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

Model Number ESS305

Device Problems Break (1069); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This spontaneous case describes the occurrence of medical device removal ('had her fallopian tube opened laparoscopically and has had it removed, leaving behind remnants/has had the device removed in a completely different way') and device breakage ('has had it removed, leaving behind remnants') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criterion medically significant) and complication of device removal ("leaving behind remnants").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the medical device removal, device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage and medical device removal to be related to essure.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case describes the occurrence of medical device removal ('had her fallopian tube opened laparoscopically and has had it removed, leaving behind remnants / has had the device removed in a completely different way') and device breakage ('has had it removed, leaving behind remnants') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criterion medically significant) and complication of device removal ("leaving behind remnants").The patient was treated with surgery (essure removal).At the time of the report, the medical device removal, device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage and medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-may-2020: quality safety evaluation of ptc.On 25-may-2020: no new clinical information provided.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case describes the occurrence of medical device removal ('had her fallopian tube opened laparoscopically and has had it removed, leaving behind remnants / has had the device removed in a completely different way') and device breakage ('has had it removed, leaving behind remnants') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced device breakage (seriousness criterion medically significant) and complication of device removal ("leaving behind remnants").The patient was treated with surgery (essure removal).At the time of the report, the medical device removal, device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage and medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 6-apr-2021: ha number re-sent.No new information received, update to imdrf/fda codes only.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary 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: 10054307
• MDR Text Key: 190889997
• Report Number: 2951250-2020-07321
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• 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
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention