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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Failure of Implant (1924); Discomfort (2330); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2011

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("coils expelled and embedded"), device breakage ("coils broke during removal procedure") and device expulsion ("coils expelled and embedded") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2009, the patient had essure inserted.In 2011, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("she has fragments inside her").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required) and malaise ("sicker").The patient was treated with surgery (hysterectomy in 2011) and surgery (total hysterectomy scheduled).Essure was removed.At the time of the report, the embedded device, device breakage, device expulsion and complication of device removal outcome was unknown and the malaise had not resolved.The reporter considered complication of device removal, device breakage, device expulsion, embedded device and malaise to be related to essure.The reporter commented: consumer stated that coils broke inside her during removal procedure.She has fragments insider her (total hysterectomy was scheduled).Incident no lot n:umber 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

Ntaneous case was reported by a lawyer and describes the occurrence of embedded device ("coils expelled and embedded"), device breakage ("coils broke during removal procedure") and device expulsion ("coils expelled and embedded") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2009, the patient had essure inserted.In 2011, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("she has fragments inside her").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required) and malaise ("sicker").The patient was treated with surgery (hysterectomy in 2011) and surgery (total hysterectomy scheduled).Essure was removed.At the time of the report, the embedded device, device breakage, device expulsion and complication of device removal outcome was unknown and the malaise had not resolved.The reporter considered complication of device removal, device breakage, device expulsion, embedded device and malaise to be related to essure.The reporter commented: consumer stated that coils broke inside her during removal procedure.She has fragments insider her (total hysterectomy was scheduled).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-oct-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: 7642249
• MDR Text Key: 112486419
• Report Number: 2951250-2018-02856
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• 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
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention