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

Model Number ESS305

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

This spontaneous case was reported by a physician (b)(6) and describes the occurrence of complication of device removal ("removal was difficult as the insert was stuck in the uterine tube"), the first episode of device deployment issue ("the insert was not released because the thumb-wheel became jammed for three inserts during three procedures"), the second episode of device deployment issue ("the insert was not released because the thumb-wheel became jammed for three inserts during three procedures") and the third episode of device deployment issue ("the insert was not released because the thumb-wheel became jammed for three inserts during three procedures") in a female patient who had essure (batch no.623833) inserted.Other product or product use issues identified: device difficult to use "removal was difficult as the insert was stuck in the uterine tube" (seriousness criterion medically significant) in 2007.On (b)(6) 2007, the patient had 3 attempts to have essure inserted.During these attempts, she experienced device deployment issue ("the insert was not released because the thumb-wheel became jammed for three inserts during three procedures").In addition, during one of these insertion attempts, she experienced device difficult to use and complication of device removal ("removal was difficult as the insert was stuck in the uterine tube").At the time of the report, the complication of device removal and the last episode of device deployment issue outcome was unknown.The reporter provided no causality assessment for complication of device removal, the first episode of device deployment issue, the second episode of device deployment issue and the third episode of device deployment issue with essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-oct-2017: quality safety evaluation of ptc.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 16-oct-2017 for the following meddra preferred term: device difficult to use - the analysis in the global safety database revealed 81 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.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: 7012776
• MDR Text Key: 91437791
• Report Number: 2951250-2017-06328
• 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
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 623833
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2017
• 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
• Patient Outcome(s): Other