NCT01045057 · ADVERSE EVENTS

Adverse events

Clinical Feasibility of New Tracheoesophageal Puncture Set · Source last updated 2021-06-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: During one month after the surgery
Other-event reporting threshold: 0%

all adverse events, including expected/non-related events were recorded

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Provox Vega Puncture Set Group of larynx cancer patients undergoing laryngectomy whereby the puncture and the placement of the voice prosthesis is done with the Provox Vega Puncture set	0 / 27	8 / 27	Not reported / Not reported

Group identifiers: EG000: Provox Vega Puncture Set

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
In all 3 patients known significant risk factors were present that are deemed to have caused the fistula. As such, these complications are not considered related to device/procedure. Fistula occurrence rate was within previously reported ranges.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
3
num At Risk
27
num Events
3
term
Pharyngocutaneous Fistula
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Posterior pharyngeal wall was damaged during dilatation before the puncture took place. Non-device related.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
term
Damage posterior pharyngeal wall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Puncture penetrated posterior esophageal wall because window of device used for pharynx protection (not part of subject device)could not be located by palpation or visualization. Event did not cause any harm to patient. Event is not device related.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
term
Damage posterior esophageal wall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Voice prosthesis retracted while cleaning it, and was repositioned. No patient harm. Event is related to patient anatomy, not related to device/procedure.Occurred in home situation, can occur when voice prosthesis (e.g. due to edema) fits too tight.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
term
Retracted voice prosthesis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Patient developed tracheitis, caused by COPD and the related use of Prednisone and inhalation medications. Patient received antibiotics and was fine. Event was unrelated to device.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
term
Tracheitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Wound healing problems considered to be caused by pre-existing risk factors (Radiotherapy,prednisone use)and surgical risk factor of bilateral neck dissection.Not device related.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
term
Wound dehiscence

Complete source fields

description

all adverse events, including expected/non-related events were recorded

event Groups

description
Group of larynx cancer patients undergoing laryngectomy whereby the puncture and the placement of the voice prosthesis is done with the Provox Vega Puncture set
id
EG000
other Num Affected
8
other Num At Risk
27
serious Num Affected
0
serious Num At Risk
27
title
Provox Vega Puncture Set

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
In all 3 patients known significant risk factors were present that are deemed to have caused the fistula. As such, these complications are not considered related to device/procedure. Fistula occurrence rate was within previously reported ranges.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
3
num At Risk
27
num Events
3
term
Pharyngocutaneous Fistula
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Posterior pharyngeal wall was damaged during dilatation before the puncture took place. Non-device related.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
term
Damage posterior pharyngeal wall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Puncture penetrated posterior esophageal wall because window of device used for pharynx protection (not part of subject device)could not be located by palpation or visualization. Event did not cause any harm to patient. Event is not device related.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
term
Damage posterior esophageal wall
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Voice prosthesis retracted while cleaning it, and was repositioned. No patient harm. Event is related to patient anatomy, not related to device/procedure.Occurred in home situation, can occur when voice prosthesis (e.g. due to edema) fits too tight.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
term
Retracted voice prosthesis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Patient developed tracheitis, caused by COPD and the related use of Prednisone and inhalation medications. Patient received antibiotics and was fine. Event was unrelated to device.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
term
Tracheitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Wound healing problems considered to be caused by pre-existing risk factors (Radiotherapy,prednisone use)and surgical risk factor of bilateral neck dissection.Not device related.
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
1
num At Risk
27
num Events
1
term
Wound dehiscence

time Frame

During one month after the surgery

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Preserved source evidence · Not medical advice