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

Model Number ESS305

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Internal Organ Perforation (1987); Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("caused the essure coils to migrate"), device breakage ("device fracture") and perforation ("perforated organs") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), perforation (seriousness criterion medically significant) and pain ("pain").The patient was treated with surgery (numerous surgical procedures).Essure was removed.At the time of the report, the device dislocation, device breakage, perforation and pain outcome was unknown.The reporter considered device breakage, device dislocation, pain and perforation to be related to essure.The reporter commented: plaintiff had to undergo numerous surgical procedures, diagnostic procedures, and may have to undergo surgeries, diagnostic testing, treatment and rehabilitation into the indefinite future.Incident 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("caused the essure coils to migrate"), device breakage ("device fracture") and perforation ("perforated organs") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), perforation (seriousness criterion medically significant) and pain ("pain").The patient was treated with surgery (numerous surgical procedures) and surgery (numerous surgical procedures).Essure was removed.At the time of the report, the device dislocation, device breakage, perforation and pain outcome was unknown.The reporter considered device breakage, device dislocation, pain and perforation to be related to essure.The reporter commented: plaintiff had to undergo numerous surgical procedures, diagnostic procedures, and may have to undergo surgeries, diagnostic testing, treatment and rehabilitation into the indefinite future.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-jun-2018: quality-safety evaluation of ptc.Incident 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: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7496253
• MDR Text Key: 107689584
• Report Number: 2951250-2018-02106
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/04/2018

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 Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 07/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention