MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problems Material Fragmentation (1261); Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a surgeon, general surgery in (b)(6) on 25-sep-2015 which refers to a female patient of unspecified age who had an attempt to have essure (fallopian tube occlusion insert) inserted, lot number d31449.The physician reported that during the insertion procedure, in the operating room and the patient with a laryngeal mask, partial retraction of the sheath and no release of the essure device occurred.A piece of metal remained in the patient's ostium.The complete essure system was kept.The physician reported there was no cause related to the patient which could explain the event.Bilateral placement was not performed because essure procedure was stopped.The postoperative course reported was possible unilateral residual permeability which required celioscopy.Follow up information received on 19-oct-2015: (b)(4).Product technical complaint (ptc) investigation and final assessment were received.The bayer reference number for the ptc report is:(b)(4).Final assessment failure mode/mechanism: 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.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 record and confirmed that final product testing for this lot was 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 the catheter breaking and detachment difficulty event is an anticipated event and there was no event reported wick indicates a new technical failure mode for the device.Medical assessment this ptc was initiated due to a reported technical product issue (breakage) in the context of a complicated insertion.No medical event(s) were reported.A review of similar cases for this batch is not applicable as no medical event(s) were reported.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship to a quality defect.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had an attempt to have essure (fallopian tube occlusion insert) inserted and a piece of metal remained in the ostium during insertion procedure.Bilateral placement was not performed because essure procedure was stopped.The event, interpreted as device breakage, is non-serious and unlisted in the reference safety information for essure.According to the product technical complaint analysis, the possibility of the catheter breaking is an anticipated event.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure insertion procedure, a causal relationship with suspect insert cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Additionally, non-serious event was reported.No sample was provided but a review of the manufacturing batch record confirmed that lot met all release requirements.Based on available information, there is no reason to suspect a causal relationship to a potential quality deficit as no defect was confirmed and no medical events were reported.Further information has been requested.

Manufacturer Narrative

Follow-up information received on 18-dec-2015: follow-up attempts have been made with no response to date.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 21-dec-2015 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 medically confirmed, spontaneous case report refers to a female patient who had an attempt to have essure (fallopian tube occlusion insert) inserted and a piece of metal remained in the ostium during insertion procedure.Bilateral placement was not performed because essure procedure was stopped.The event, interpreted as device breakage, is non-serious and unlisted in the reference safety information for essure.According to the product technical complaint analysis, the possibility of the catheter breaking is an anticipated event.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure insertion procedure, a causal relationship with suspect insert cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Additionally, non-serious event was reported.No sample was provided but a review of the manufacturing batch record confirmed that lot met all release requirements.Based on available information, there is no reason to suspect a causal relationship to a potential quality deficit as no defect was confirmed and no medical events were reported.Despite follow up attempts, no further information was obtained.

Manufacturer Narrative

The ptc investigation result was updated and received on 22-feb-2016.(b)(4).Final assessment detachment difficulty is defined as a failure of the micro-insert to detach (separate) from the delivery system.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper detachment: rollback to initial hard stop.Depress button.Perform final rollback.Under normal circumstances, when the physician completes all deployment steps as outlined in the ifu, the micro-insert assembly will detach from the delivery wire and remain in the fallopian tube.Several factors can contribute to a detachment 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 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.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.As received, no micro-insert returned, inner catheter was stretched and all ifu steps were completed.We were unable to confirm any quality defect of device malfunction at this time.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.The possibility of a detachment difficulty event 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 ae cases is not applicable.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 23-feb-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 medically confirmed, spontaneous case report refers to a female patient who had an attempt to have essure (fallopian tube occlusion insert) inserted and a piece of metal remained in the ostium during insertion procedure.Bilateral placement was not performed because essure procedure was stopped.The event, interpreted as device breakage, is non-serious and unlisted in the reference safety information for essure.According to the product technical complaint analysis, the possibility of the catheter breaking is an anticipated event.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure insertion procedure, a causal relationship with suspect insert cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Additionally, non-serious event was reported.Since product was returned, an investigation of the actual device involved in this complaint was performed.Based on the available information no product quality defect was confirmed.Despite follow up attempts, no further information was obtained.

Manufacturer Narrative

Data correction: the product code knh was replaced with hhs.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5166374
• MDR Text Key: 28907192
• Report Number: 2951250-2015-01211
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2017
• Device Model Number: ESS305
• Device Lot Number: D31449
• Other Device ID Number: (01)10888853003051(17)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2014
• 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