MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hemorrhage/Bleeding (1888); Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Type Injury

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain") and dysfunctional uterine bleeding ("dysfunctional uterine bleeding") in a (b)(6) female patient who received essure.The occurrence of additional non-serious events is detailed below.In (b)(6) 2008, the patient started essure.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and clinically significant/intervention required), dysfunctional uterine bleeding (seriousness criteria medically significant and clinically significant/intervention required) with vaginal haemorrhage, fatigue ("fatigue"), abdominal pain ("abdominal pain"), and dysmenorrhoea.The patient was treated with total vaginal hysterectomy with an attempted removal of her essure coils on (b)(6) 2015; and the patient experienced device breakage , device difficult to use and complication of device removal ("one of the essure coils was not fully removed during surgery and remains in plaintiff's body").Essure was withdrawn.At the time of the report, the pelvic pain, dysfunctional uterine bleeding, dysmenorrhoea, fatigue, device breakage, complication of device removal and device difficult to use outcome was unknown and the abdominal pain had not resolved.The reporter considered pelvic pain, dysfunctional uterine bleeding, abdominal pain, dysmenorrhoea, fatigue, device breakage, complication of device removal and device difficult to use to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): on (b)(6) 2009: hysterosalpingogram result was bilateral fallopian tubes occluded.On (b)(6) 2010: computerised tomogram pelvis result was not provided.On (b)(6) 2015: laparoscopy result was not provided.On (b)(6) 2010: computerised tomogram pelvis (cont.) - performed with contrast due to chronic pelvic pain and dysfunctional uterine bleeding.On (b)(6) 2015: diagnostic laparoscopy (cont.) - to evaluate her heavy and painful vaginal bleeding.Company causality comment: this spontaneous case report refers to a female consumer who had essure inserted and experienced chronic pelvic pain and dysfunctional uterine bleeding.Approximately 7 years after insertion, she underwent a total vaginal hysterectomy with an attempted removal of her essure® coils; however, one of the coils was not fully removed during surgery and remains in consumer's body (seen as device breakage and complication of device removal).All these reported events are anticipated in the reference safety information for essure.Pelvic pain and changes in bleeding pattern, including heavy and unscheduled bleeding, may occur within consumer under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between these events and suspected insert cannot be excluded.During difficult insertions and removals, single cases of essure breakage have been reported.In this particular case, the exact time point of breakage is not clear and it was only noted during removal procedure.Based on the nature of this event, it was also assessed as related to essure.This case was regarded as incident since intervention was required.A product technical analysis is being sought.No active follow-up is allowed and further information is expected only through litigation process.

Manufacturer Narrative

Quality-safety evaluation of ptc: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The inserts outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.Sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility of micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 23-mar-2017: quality-safety evaluation of ptc.Company causality comment: this spontaneous case report refers to a female consumer who had essure inserted and experienced chronic pelvic pain and dysfunctional uterine bleeding.Approximately 7 years after insertion, she underwent a total vaginal hysterectomy with an attempted removal of her essure® coils; however, one of the coils was not fully removed during surgery and remains in consumer's body (seen as device breakage and complication of device removal).All these reported events are anticipated in the reference safety information for essure.Pelvic pain and changes in bleeding pattern, including heavy and unscheduled bleeding, may occur within consumer under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between these events and suspected insert cannot be excluded.During difficult insertions and removals, single cases of essure breakage have been reported.In this particular case, the exact time point of breakage is not clear and it was only noted during removal procedure.Based on the nature of this event, it was also assessed as related to essure.This case was regarded as incident since intervention was required.A product quality defect could not be confirmed but is considered plausible.No active follow-up is allowed and further information is expected only through litigation process.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain'), device breakage ('one of the essure coils was not fully removed during surgery and remains in plaintiff's body'), device dislocation ('device migration') and dysfunctiona(b)(6) l uterine bleeding ('dysfunctional uterine bleeding') in a 37-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), device dislocation (seriousness criteria medically significant and intervention required), dysfunctional uterine bleeding (seriousness criteria medically significant and intervention required) with vaginal haemorrhage, abdominal pain ("abdominal pain"), dysmenorrhoea ("painful vaginal bleeding"), fatigue ("fatigue") and complication of device removal ("one of the essure coils was not fully removed during surgery and remains in plaintiff's body").The patient was treated with surgery (total vaginal hysterectomy with an attempted removal of her essure coils on (b)(6) 2015).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, device breakage, device dislocation, dysfunctional uterine bleeding, dysmenorrhoea, fatigue and complication of device removal outcome was unknown and the abdominal pain had not resolved.The reporter considered abdominal pain, complication of device removal, device breakage, device dislocation, dysfunctional uterine bleeding, dysmenorrhoea, fatigue and pelvic pain to be related to essure.The reporter commented: she still has a partial device implanted.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram pelvis - on (b)(6) 2010: results: not provided.Hysterosalpingogram - on (b)(6) 2009: results: bilateral fallopian tubes occluded.Laparoscopy - on (b)(6) 2015: results: not provided.Diagnostic results: on (b)(6) 2010: computerised tomogram pelvis (cont.) - performed with contrast due to chronic pelvic pain and dysfunctional uterine bleeding.On (b)(6) 2015: diagnostic laparoscopy (cont.) - to evaluate her heavy and painful vaginal bleeding.Quality-safety evaluation of ptc: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The inserts outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.Sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility of micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 28-aug-2020: pif received- new event device migration was added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

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Brand Name

ESSURE

Type of Device

TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Manufacturer (Section D)

BAYER PHARMA AG

müllerstr. 178

berlin, 13353

GM 13353

MDR Report Key

6435735

MDR Text Key

70907258

Report Number

2951250-2017-01061

Device Sequence Number

Product Code

HHS

Combination Product (y/n)

PMA/PMN Number

P020014

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Health Professional

Device Model Number

ESS305

Device Catalogue Number

ESS305

Was Device Available for Evaluation?

Initial Date Manufacturer Received

02/28/2017

Initial Date FDA Received

03/27/2017

Supplement Dates Manufacturer Received

Not provided
08/28/2020
09/16/2020
06/15/2021

Supplement Dates FDA Received

04/20/2017
09/10/2020
09/16/2020
06/21/2021

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention;

Patient Age

37 YR

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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