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

Model Number ESS305

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Inflammation (1932); Pain (1994); Uterine Perforation (2121)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a female consumer of unspecified age via regulatory authority in (b)(6) ((b)(4)) on 31-mar-2016.The consumer had essure (fallopian tube occlusion insert) inserted on (b)(6) 2014.It was reported that the patient experienced protrusion and perforation of right fallopian tube, pain, inflammation and her mental and emotional health were affected.The consumer had the right coils removed on (b)(6) 2016.Left coils were left in situ.The date of adverse event was reported as (b)(6) 2014 but it was not assigned to any specific event.The outcome of the event protrusion and perforation of right fallopian tube was recovered / resolved.Reporter causality was not reported.Company causality comment: this spontaneous case report was received via health authority and refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced protrusion and perforation of right fallopian tube.The right essure coil was removed (approximately 1.5 years after its placement).The reported event is listed according to essure's reference safety information.Fallopian tube perforation may occur with any trans-cervical intrauterine procedure; including insertion of a fallopian tubal occlusion insert (essure).In this particular case, although the exact mechanism of the reported event is not known; given its nature, causality with essure cannot be excluded.Non-serious events were also reported.This case was considered an incident, since device removal was required.A product technical analysis is being sought.

Manufacturer Narrative

Follow up information received on 19-may-2016: quality-safety evaluation of product technical complaint (ptc): this adverse event report is related to a ptc and the bayer reference number for the ptc report is (b)(4).In this case, no product was returned.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.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.There was not event reported which indicates a new technical failure mode for this device.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.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 19-may-2016 for the following meddra preferred term: fallopian tube perforation.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 spontaneous case report was received via health authority and refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced protrusion and perforation of right fallopian tube.The right essure coil was removed (approximately 1.5 years after its placement).The reported event is listed according to essure's reference safety information.Fallopian tube perforation may occur with any trans-cervical intrauterine procedure; including insertion of a fallopian tubal occlusion insert (essure).In this particular case, although the exact mechanism of the reported event is not known; given its nature, causality with essure cannot be excluded.Non-serious events were also reported.This case was considered an incident, since device removal was required.The outcome of the technical investigation resulted in an unconfirmed quality defect.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: 5611959
• MDR Text Key: 43811840
• Report Number: 2951250-2016-00422
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2016
• 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
• Patient Outcome(s): Other; Required Intervention