MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

On march 3, 2017, bayer received a cluster of essure complaint reports originating from the (b)(6), device vigilance database via legal proceedings.Following receipt, bayer consulted (b)(6) in order to obtain the relevant case reference number information.On march 24, 2017, (b)(6) 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.

Event Description

This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("even by pulling on the catheter it was not possible to withdraw it, the catheter broke/ then, the insert broke when the physician pulled on it during examination on the table"), device deployment issue ("during placement of essure in the left tube, after release, the insert remained attached to the delivery catheter/ upon inspection of the system after withdrawal from the cavity, it was noted that the insert had not been released"), device difficult to use ("a piece, probably in plastic, remained in the tube (a piece was retrieved using forceps for foreign bodies).What will become of the piece remaining in the tube is also uncertain.") and complication of device insertion ("even by pulling on the catheter it was not possible to withdraw it, the catheter broke/ then, the insert broke when the physician pulled on it during examination on the table") in a female patient who had essure (batch no.B44004) inserted.Other product or product use issues identified: device ineffective "occlusion of the tube is uncertain".On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced device breakage, device deployment issue, device difficult to use and complication of device insertion.At the time of the report, the device breakage, device deployment issue, device difficult to use and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue and device difficult to use with essure.The reporter commented: another device was placed in the other tube with no problems.Hysterography is planned in 3 months.Company causality comment: this spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and even by pulling on the catheter it was not possible to withdraw it, the catheter broke/ then, the insert broke when the physician pulled on it during examination on the table.Hysterography was planned in 3 months.This event, interpreted as device breakage, is anticipated in the reference safety information for essure.In the present case the device breakage occurred during essure insertion procedure, therefore causality with essure cannot be excluded.Although there was no reported death or serious health deterioration, this might have occurred under less fortunate circumstances and therefore case was regarded as a reportable incident.A product technical analysis and further information are expected.

Manufacturer Narrative

This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("even by pulling on the catheter it was not possible to withdraw it, the catheter broke.Then, the insert broke when the physician pulled on it during examination on the table"), device deployment issue ("during placement of essure in the left tube, after release, the insert remained attached to the delivery catheter.Upon inspection of the system after withdrawal from the cavity, it was noted that the insert had not been released"), complication of device removal ("a piece, probably in plastic, remained in the tube (a piece was retrieved using forceps for foreign bodies).What will become of the piece remaining in the tube is also uncertain.") and complication of device insertion ("even by pulling on the catheter it was not possible to withdraw it, the catheter broke/ then, the insert broke when the physician pulled on it during examination on the table") in a female patient who had essure (batch no.B44004) inserted.Other product or product use issues identified: device ineffective "occlusion of the tube is uncertain".On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced device breakage, device deployment issue, complication of device removal and complication of device insertion.At the time of the report, the device breakage, device deployment issue, complication of device removal and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion, complication of device removal, device breakage and device deployment issue with essure.The reporter commented: another device was placed in the other tube with no problems.Hysterography is planned in 3 months.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 16-jun-2017 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.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 15-jun-2017: no further information was received after follow-up attempts.Company causality comment: 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.

Manufacturer Narrative

This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("even by pulling on the catheter it was not possible to withdraw it, the catheter broke/ then, the insert broke when the physician pulled on it during examination on the table"), device deployment issue ("during placement of essure in the left tube, after release, the insert remained attached to the delivery catheter/ upon inspection of the system after withdrawal from the cavity, it was noted that the insert had not been released"), complication of device removal ("a piece, probably in plastic, remained in the tube (a piece was retrieved using forceps for foreign bodies).What will become of the piece remaining in the tube is also uncertain.") and complication of device insertion ("even by pulling on the catheter it was not possible to withdraw it, the catheter broke/ then, the insert broke when the physician pulled on it during examination on the table") in a female patient who had essure (batch no.B44004) inserted.Other product or product use issues identified: device ineffective "occlusion of the tube is uncertain".On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced device breakage, device deployment issue, complication of device removal and complication of device insertion.At the time of the report, the device breakage, device deployment issue, complication of device removal and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion, complication of device removal, device breakage and device deployment issue with essure.The reporter commented: another device was placed in the other tube with no problems.Hysterography is planned in 3 months.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 (b)(6) 2017 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1.793 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: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-oct-2017: quality-safety evaluation of ptc.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: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• 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. shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6537436
• MDR Text Key: 74410299
• Report Number: 2951250-2017-01864
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: B44004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2017
• 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