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

Model Number ESS305

Device Problems Break (1069); Separation Failure (2547)

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

Event Type  Injury  

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, lot number c13141.Physician reported that essure implant did not get off from catheter normally, it stuck in catheter and also in patient, while removing the implant, structure of the catheter had broken and some green material had appeared.The implant was anyway managed to remove from patient and a new implant was successfully inserted so bilateral insertion of implants was achieved.Sample is available.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and during essure insertion procedure, implant did not get off from catheter (device deployment issue), it stuck in patient (embedded device) and while removing the implant, structure of catheter had broken and some green material had appeared (device breakage).The event embedded device is serious due to medical importance and listed in the reference safety information for essure.The event device breakage is non-serious and unlisted.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body), dislocation (distal fallopian tube or peritoneal cavity) or occur as a result of uterine perforation, mainly during insertion.Also, during difficult insertion/removals, single cases have been reported of essure breakage.As the breakage and embedment occurred during essure placement procedure, a causal relationship between these events and 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.A product technical analysis is being sought.

Manufacturer Narrative

Ptc investigation results received on 09-mar-2015: ptc global number: (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 insert's grip on the delivery wire, and potential manufacturing deficiencies.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.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.We typically inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly.As received, all ifu steps were completed.No micro-insert was returned.The catheter large tight pitch coil found to be stretched and broken.A portion of green tubing found to be broken.The root case of the breakage is unknown.We were unable to confirm any quality defect or 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 and catheter breakage events during the procedure is an anticipated event.Medical assessment: this ptc was initiated due to a product quality issue reported in the context of a complicated removal of a reportedly embedded device.The ae case refers to a usability issue.The batch documentation of the reported batch was reviewed.The returned complaint sample was investigated.The technical assessment concluded unconfirmed quality defect.The reported adverse event is a known, possible, undesirable event and not indicative of a quality deficit per se.No further ae case reports have been received to date in relation to the reported batch.No batch signal could be identified.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.The list of similar cases contains reports with similar events coded in meddra.It includes recent cases received by bayer pharma and older cases received from the previous owner of the essure product (conceptus).These legacy reports have been re-coded according to bayer pharma standards.In this particular case a search in the database was performed on 11-mar-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.This includes consideration of the legacy cases in safety analyses.The cumulative review of the reports has not yielded any new safety signal.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had an attempt of essure (fallopian tube occlusion insert) insertion and during this procedure, implant did not get off from catheter (device deployment issue), it stuck in patient (embedded device) and while removing the implant, structure of catheter had broken and some green material had appeared (device breakage).All events are listed in the reference safety information for essure and according to product technical analysis (ptc/ device breakage).Embedded device is serious due to medical importance, while the other events are non-serious.During difficult insertions/removals, single cases have been reported of essure breakage.In this particular case, as the reported events occurred during essure placement procedure, causality with the 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.Ptc analysis conduct an investigation of the actual device involved in this complaint (no micro-insert was returned); the catheter large tight pitch coil was found to be stretched and broken and a portion of green tubing was found to be broken.The root cause of the breakage was unknown and they were unable to confirm any quality defect or device malfunction.Ptc medical assessment considered there is no reason to suspect a causal relationship to a potential quality deficit based on this report.No further information is expected.

Manufacturer Narrative

Data correction for us reporting: the 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: 4581873
• MDR Text Key: 20788850
• Report Number: 2951250-2015-00172
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: ESS305
• Device Lot Number: C13141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2014
• 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 Outcome(s): Other