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

Model Number ESS305

Device Problems Material Fragmentation (1261); Problem with Sterilization (1596)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a health professional in (b)(6) on 17-nov-2016 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2016.Surgeon was trained to essure insertion procedure.During essure insertion procedure performed on (b)(6) 2016, at introduction of device into hysteroscope, a fragment of essure insert used during the previous insertion procedure came out into the patient.The pharmacist then clarified that a part of the sheath remained in hysteroscope and was extracted during the following essure insertion procedure when another device was introduced in hysteroscope.((b)(4) was created for the previous insertion procedure).Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and during the procedure a part of sheath of device used during the previous insertion procedure came out into the patient.This event was considered anticipated in the reference safety information for essure.In the present case, a part of the sheath from a previous essure procedure remained in the hysteroscope.During essure insertion, at introduction of device into hysteroscope, the fragment came out into the patient.The fact that the fragment from a previous insertion procedure remained in the hysteroscope suggests that an inadequate hysteroscope disinfection/ sterilization process occurred.However, given the nature of the reported event, a causal relationship with essure cannot be excluded.This case was regarded as other reportable incident, as although the event did not lead to serious health deterioration this might have occurred under less fortunate circumstances.Further information and product technical analysis are being sought.

Manufacturer Narrative

This spontaneous case was reported by an other health professional and describes the occurrence of wrong technique in device usage process ("a part of sheath of device used during the previous insertion procedure came out into the patient") in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On (b)(6) 2016, the patient experienced wrong technique in device usage process.At the time of the report, the wrong technique in device usage process outcome was unknown.The reporter provided no causality assessment for wrong technique in device usage process with essure.The reporter commented: (case (b)(6) was created for the previous insertion procedure).The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 30-may-2017 for the following meddra preferred terms: wrong technique in device usage process: 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.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.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 llt: device use error.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.Most recent follow-up information incorporated above includes: on 29-may-2017: quality safety evaluation of ptc.Company causality comment: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• 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. lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6167354
• MDR Text Key: 62187143
• Report Number: 2951250-2016-02667
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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