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); Device Dislodged or Dislocated (2923)

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

Event Type  Injury  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of uterine perforation ("they found multiple perforations") and device dislocation ("one coil suspected of being located in the mesentery of the colon") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: no known history of pelvic pain before any of the essure placements.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), procedural pain ("had three previous failed attempts at essure placement who complained of pain"), complication of device insertion ("had three previous failed attempts at essure placement who complained of pain") and complication of device removal ("one remaining coil suspected of being located in the mesentery of the colon, plans to remove remaining coil").The patient was treated with surgery (underwent a hysterectomy) and surgery (md plans to remove remaining coil).At the time of the report, the uterine perforation, procedural pain, complication of device insertion and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device insertion, complication of device removal, device dislocation, procedural pain and uterine perforation with essure.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: several perforations in various locations.Post-op she was found on x-ray to have one remaining coil suspected of being located in the mesentery of the colon.Company causality comment: 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
• 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: 6684208
• MDR Text Key: 78985803
• Report Number: 2951250-2017-02430
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Date Manufacturer Received: 06/16/2017
• 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; Required Intervention