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

Model Number ESS305

Device Problems Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of device dislocation ("metallic foreign body in her abdomen, which appears to be the essure / floating free in her abdominal cavity") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "could not place insert into right tube; apparently it was blocked or just couldn't get it in" in (b)(6) 2015.In (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and adverse event ("she was seen for some other complaint in the er").Essure treatment was not changed.At the time of the report, the device dislocation and adverse event outcome was unknown.The reporter provided no causality assessment for adverse event and device dislocation with essure.The reporter commented: doctor is planning to perform a laparoscopy to remove these things so that it does not perforate her bowel or any other structure because it is definitely floating free in her abdominal cavity.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2016: both tubes occluded on (b)(6) 2017, ct scan done and it showed she had a metallic foreign body in her abdomen, which appears to be the essure.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
• 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: 6837574
• MDR Text Key: 84330418
• Report Number: 2951250-2017-03325
• 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: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2017
• 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
• Patient Age: 34 YR