MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problems Bent (1059); Difficult to Remove (1528); Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a pharmacist in (b)(6) on (b)(6) 2015 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted on an unspecified date with lot number d35370 (expiration date 28-nov-2017) and c68800 (expiration date 30-jun-2017).It was reported that with lot d35370, first implant could not be placed as it was bent into delivery catheter and with lot c68800, second implant did not release during insertion attempt; moreover, implant broke during removal prolonging intervention duration.No occurrence of adverse event.Essure insertion was performed with no difficulty with each remaining implant from both batches.Company causality comment this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and implant broke during removal.This event, interpreted as device breakage, is non-serious and listed in the reference safety information for essure.In the present case, implant did not release during insertion attempt and broke during removal, therefore causality with the essure procedure cannot be excluded.Insertion was performed with no difficulty with the remaining implant.This case was regarded as other reportable incident, as although the reported device breakage did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.A product technical analysis and further information are expected.

Manufacturer Narrative

Ptc investigation result was received on 18-jan-2016.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc global number (b)(4).(b)(4).Final assessment: deployment difficulty is defined as a failure of the micro-insert outer coils to expand from the wound down position.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper deployment: rollback to initial hard stop; depress button; perform final rollback.Under normal circumstances, when the physician completes the proper essure placement steps, the release ribbon should disengage from the platinum half band (welded onto outer coils of micro-insert).Once disengagement occurs, the outer coils should expand.If it does not, this is referred to deployment difficulty.Several factors can contribute to a deployment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from expanding and releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the inserts grip on the delivery wire, and potential manufacturing deficiencies.For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.We conducted a review of the manufacturing batch records (c68800 production date 30-jun-2014 and expiration date 30-jun-2017; d35370 production date 27-nov-2014 and expiration date 28-nov-2017) and confirmed that final product testing for these lots were performed per requirements and the product met all release requirements.We were unable to confirm any quality defect or device malfunction at this time.The possibility of a deployment difficulty event, bent tip and device breakage is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information no product quality defect was confirmed.Moreover, no medical events were reported at this time, therefore the assessment of a relationship with a quality defect is not applicable.Since no medical events were reported, a batch investigation with respect to similar adverse event cases is not applicable.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 19-jan-2016 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and implant broke during removal.This event, interpreted as device breakage, is non-serious and listed in the reference safety information for essure.In the present case, implant did not release during insertion attempt and broke during removal, therefore causality with the essure procedure cannot be excluded.Insertion was performed with no difficulty with the remaining implant.This case was regarded as other reportable incident, as although the reported device breakage did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.In this case, no product was returned.A review of the manufacturing batch records was conducted and confirmed that final product testing for these lots were performed per requirements and the product met all release requirements.Based on the available information no product quality defect was confirmed.Despite follow-up attempt, no further information was obtained.

Manufacturer Narrative

Device breakage questionnaire received on (b)(4) 2016: the patient's date of birth was updated.The breakage of implant was diagnosed during placement.There was no difficulty to introduce catheter in right ostium but implant did not deploy correctly (remained in wound-down configuration in uterus).In front of the efficiency doubt, implant was removed with pliers.Implant removal was difficult and it took a long time as implant broke and remained very in adhered to the fallopian tube.The instructions in the ifu were followed.Essure was removed on the day of the placement ((b)(6) 2015).Essure was removed because it was medically necessary not because of patient request.The broken pieces were retrieved in abdomen/pelvis.Broken pieces were not kept.There was no patient injury but intervention duration was prolonged.The device was partially available.The patient recovered.Device similar case listing.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(4) 2016 for the following meddra preferred terms: device breakage: the analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pt.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and implant broke during removal.This event, interpreted as device breakage, is non-serious and listed in the reference safety information for essure.In the present case, implant did not release during insertion attempt and broke during removal, therefore causality with the essure procedure cannot be excluded.Insertion was performed with no difficulty with the remaining implant.This case was regarded as other reportable incident, as although the reported device breakage did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.In this case, no product was returned.A review of the manufacturing batch records was conducted and confirmed that final product testing for these lots were performed per requirements and the product met all release requirements.Based on the available information no product quality defect was confirmed.

Manufacturer Narrative

Follow up information received on 26-oct-2016: updated quality-safety evaluation of product technical complaint (ptc) upon sample receipt.This adverse event report is related to a ptc and the bayer reference number for the ptc report is (b)(4).Batch c68800 (production date 30-jun-2014/ expiration date 30-jul-2016) sample was received.Batch d35370 (production date 27-nov-2014/ expiration date 28-nov-2016) sample was not returned.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 (instructions for use) 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.Deployment difficulty is defined as a failure of the micro-insert outer coils to expand from the wound down position.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper deployment: rollback to in wal hard stop; depress button; perform final rollback.Under normal circumstances, when the physician completes the proper essure placement steps, the release ribbon should disengage from the platinum half band (welded onto outer coils of micro-insert).Once disengagement occurs, the outer coils should expand.If it does not, this is referred to deployment difficulty.Several factors can contribute to a deployment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from expanding and releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the inserts grip on the deliver wire, and potential manufacturing deficiencies.We conducted an investigation of the actual device involved in this complaint.Visual inspection was performed and it was confirmed that all components are present.All ifu (instructions for use) steps were completed, inner catheter and delivery wire bonds were cured, and coil catheter was found stretched.Micro insert was not returned for this investigation therefore we are not able to investigate the reported breakage during removal.In regards of dimensional inspection as per device condition, dimensions were not able to be performed.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, it is possible the essure device could have been defective prior to removal from the package.We also conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.The possibility of a deployment difficulty, breakage and bent tip are anticipated events and there was no event reported which indicates a new technical failure mode for the device.Based on the available information a product quality defect could not be confirmed but is considered plausible.Based on the provided information the defect type corresponds to the following meddra ll: device use error and device deployment issue.Since no medical events were reported at this point in time, the assessment of a relationship with a quality defect, as well as a batch investigation with respect to similar ae cases are not applicable.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 28-oct-2016 for the following meddra preferred term: device breakage: the analysis in the global safety database revealed 1421 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pt.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and implant broke during removal.This event, interpreted as device breakage, is non-serious and listed in the reference safety information for essure.In the present case, implant did not release during insertion attempt and broke during removal, therefore causality with the essure procedure cannot be excluded.Insertion was performed with no difficulty with the remaining implant.This case was regarded as other reportable incident, as although the reported device breakage did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.In this case, no product was returned.A review of the manufacturing batch records was conducted and confirmed that final product testing for these lots were performed per requirements and the product met all release requirements.Based on the available information a product quality defect could not be confirmed but is considered plausible.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd.; milpitas CA 95035
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd., p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5240309
• MDR Text Key: 32227308
• Report Number: 2951250-2015-01614
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: D35370 / C68800
• Other Device ID Number: (01)10888853003051(17)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 42 YR