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

Model Number ESS305

Device Problems Break (1069); Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in (b)(6) on (b)(6) 2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2015 for sterilization (lot number c35394).Essure inserted via a storz trophy hysteroscope, positioned in tubal ostea and wheel wound back to retract introducer catheter and button deployed.But when wheel retracted for the second time the catheter would not separate and the essure coil stretched and broke off, leaving some material in the uterus, green plastic and broken metal which was retrieved by the surgeon.A second micro-insert was tried and a similar result occurred but micro-insert was delivered and was in situ.Introducer catheters retrieved were catheter minus the micro-insert and the second minus the micro-insert and an elongated guidewire.Three essure catheters were used in all and 2 implants are in situ.No additional information was provided.Follow up information received on (b)(6) 2015: the patient was (b)(6) years old at time of the insertion.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and during a difficult insertion, essure broke off leaving material in the uterus (green plastic and broken metal) which was retrieved by surgeon.This event, seen as device breakage, is non-serious and unlisted in the reference safety information for essure.During difficult insertions or removals, essure device breakage may occur.In this case, essure was positioned in tubal ostea and when the wheel retracted for the second time, the catheter would not separate and the essure coil stretched and broke off, leaving some material in the uterus (green plastic and broken metal).This material was then retrieved per physician.A second micro-insert was attempted and a similar result occurred but micro-insert was delivered and was in situ.Considering the reported event has occurred associated to insertion procedure, causality with essure use cannot be excluded.This case is assessed as other reportable incident since the breakage in this report did not lead to serious injury, however, it might have led under less fortunate circumstances.Technical analysis and further information have been requested.

Manufacturer Narrative

Follow-up information received on 04-aug-2015: essure was removed by graspers via uterus at day of insertion attempt.No injury to the patient was reported.She was recovered and device was not available.Ptc investigation result was received on 17-aug-2015.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).Final assessment: lot c35394; mfg date: 03/2014; exp date: 03/2017.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.In this case for one of the catheters, there was difficulty getting the insert to detach from the catheter, which contributed to a catheter breakage event.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 insert's grip on the delivery wire, and potential manufacturing deficiencies.Since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we could inspect the micro-insert, the outer catheter, the inner catheter, and all parts within the handle assembly.In this case, 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 a detachment difficulty or catheter breakage event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a product technical issue.In addition, the ae case refers to a usability issue.However, no adverse events have been reported.The batch documentation of the reported batch was reviewed.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect.Since no adverse events have been reported, a batch investigation with respect to similar ae cases is not applicable.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.After internal review, correction was performed regarding information received on 17-aug-2015: final report was ticked.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 20-aug-2015 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 essure (fallopian tube occlusion insert) inserted and during a difficult insertion, essure broke off leaving material in the uterus (green plastic and broken metal) which was retrieved by surgeon.This event, seen as device breakage, is non-serious and listed according to technical investigation.During difficult insertions or removals, essure device breakage may occur.In this case, essure was positioned in tubal ostea and when the wheel retracted for the second time, the catheter would not separate and the essure coil stretched and broke off, leaving some material in the uterus (green plastic and broken metal).This material was then retrieved per physician.A second micro-insert was attempted and a similar result occurred but micro-insert was delivered and was in situ.Essure was removed per graspers via uterus at day of insertion attempt.No injury to the patient was reported.Considering the reported event has occurred associated to insertion procedure, causality with essure use cannot be excluded.This case is assessed as other reportable incident since the breakage in this report did not lead to serious injury, however, it might have led under less fortunate circumstances.Based on the available information, there is no reason to suspect a quality deficit of the product.No further information is expected.

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: 4950232
• MDR Text Key: 24651767
• Report Number: 2951250-2015-00561
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: ESS305
• Device Lot Number: C35394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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: 35 YR