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

Model Number ESS205

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of device breakage ("upon release of the insert,two pieces were detached of the distal part of the insert"), fallopian tube spasm ("tissue spasm in the ostium during placement of the left insert") and complication of device insertion ("the two fragments were removed using grasping forceps") in a female patient who received essure (ess205) (batch no.624277).On (b)(6) 2007, the patient started essure (ess205).On (b)(6) 2007, the same day after starting essure (ess205), the patient experienced device breakage, fallopian tube spasm and complication of device insertion.At the time of the report, the device breakage and complication of device insertion had resolved and the fallopian tube spasm outcome was unknown.The reporter provided no causality assessment for device breakage, fallopian tube spasm and complication of device insertion with essure (ess205).Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and it was reported that upon release of the insert, two pieces were detached of the distal part of the insert (seen as device breakage).The event device breakage is regarded as anticipated according to the reference safety information for essure.In this particular case, it was reported that tissue spasm in the ostium during placement of the left insert occurred.The two fragments were removed using grasping forceps.As the device breakage occurred during essure insertion procedure, a causal relationship with essure 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.Further information and product technical analysis are being sought.

Manufacturer Narrative

On march 3, 2017, bayer received a cluster of essure complaint reports originating from the ansm, health authority of (b)(4), device vigilance database via legal proceedings.Following receipt, bayer consulted ansm in order to obtain the relevant case reference number information.On march 24, 2017, ansm provided the available corresponding case reference numbers to bayer.Upon receipt of this information bayer evaluated and processed the cluster of essure reports within the global safety database by april 12, 2017.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of device breakage ("upon release of the insert, two pieces were detached of the distal part of the insert"), fallopian tube spasm ("tissue spasm in the ostium during placement of the left insert") and complication of device insertion ("the two fragments were removed using grasping forceps") in a female patient who had essure (ess205) (batch no.624277) inserted.On (b)(6) 2007, the patient had essure (ess205) inserted.On the same day, the patient experienced device breakage, fallopian tube spasm and complication of device insertion.At the time of the report, the device breakage and complication of device insertion had resolved and the fallopian tube spasm outcome was unknown.The reporter provided no causality assessment for complication of device insertion, device breakage and fallopian tube spasm with essure (ess205).The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on 12-jun-2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1.639 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.Most recent follow-up information incorporated above includes: on 9-jun-2017: device evaluation received.Company causality comment: other reportable incident.At the time of reporting, 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 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin 13353 ; GM 13353
• Manufacturer Contact: k. lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6534748
• MDR Text Key: 74306149
• Report Number: 2951250-2017-01791
• 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,Followup
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2009
• Device Model Number: ESS205
• Device Lot Number: 624277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 05/01/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/02/2017; 06/19/2017
• 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