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

Model Number ESS305

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 11/06/2014

Event Type  Injury  

Event Description

This is a spontaneous case report received from a health professional in (b)(6) on (b)(4) 2015 which refers to a female patient of unspecified age who had an attempt of essure (fallopian tube occlusion insert) insertion on (b)(6) 2014 with lot number c38210.It was reported that tubal sterilization with essure was attempted on patient's request and due to different contraception methods failure.During the procedure, in the operating room, there was a procedure failure.Defect and no release of left implant.As clinical consequences patient was submitted to a laparoscopic examination.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 a defect occurred; no release of left implant.She was submitted to a laparoscopic examination on the same day.This event, regarded as a device deployment issue, was considered serious due to medical importance and is listed according to essure's reference safety information.In this particular case, physician stated a defect occurred during the insertion procedure and left essure did not release; according to him, the performed laparoscopy was a consequence of the events.Although limited information was provided; since the event occurred in association with essure insertion; causality with the suspect insert cannot be excluded.Due to the intervention reported, this case was regarded as incident.A product technical analysis and follow-up information are expected.

Manufacturer Narrative

Follow-up information received on 08-sep-2015 no further information was obtained.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 09-sep-2015 for the following meddra preferred term: device deployment issue.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 of essure (fallopian tube occlusion insert) insertion and a defect occurred; no release of left implant.She was submitted to a laparoscopic examination on the same day.This event, regarded as a device deployment issue, was considered serious due to medical importance and is listed according to essure's reference safety information.In this particular case, physician stated a defect occurred during the insertion procedure and left essure did not release; according to him, the performed laparoscopy was a consequence of the events.Although limited information was provided; since the event occurred in association with essure insertion; causality with the suspect insert cannot be excluded.Due to the intervention reported, this case was regarded as incident.The product technical analysis concluded 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

The product technical complaint (ptc) investigation and final assessment were received on 08-jun-2015.The bayer reference number for the ptc report is: (b)(4).Batch number c38210 production date 19-mar-2014 expiration date 31-mar-2017.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.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 would 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 event during the procedure is an anticipated event.Medical assessment: this ptc was initiated due to a product quality issue and 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.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 a defect occurred; no release of left implant.She was submitted to a laparoscopic examination on the same day.This event, regarded as a device deployment issue, was considered serious due to medical importance and is listed according to essure's reference safety information.In this particular case, physician stated a defect occurred during the insertion procedure and left essure did not release; according to him, the performed laparoscopy was a consequence of the events.Although limited information was provided; since the event occurred in association with essure insertion; causality with the suspect insert cannot be excluded.Due to the intervention reported, this case was regarded as incident.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up 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: 4810366
• MDR Text Key: 5892310
• Report Number: 2951250-2015-00354
• 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: 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: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: ESS305
• Device Lot Number: C38210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention