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

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of implant") and device breakage ("fracturing of the implant") in a female patient who had essure inserted.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) with pelvic pain and device breakage (seriousness criteria medically significant and intervention required).The patient was treated with surgery (she had surgery to remove the essure) and surgery (she had surgery to remove the essure).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation and device breakage outcome was unknown.The reporter considered device breakage and device dislocation to be related to 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of implant/infero medial displacement of a medial marker associated with the right insert') and device breakage ('fracturing of the implant') in a 25-year-old female patient who had essure inserted for female sterilisation.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) with pelvic pain and device breakage (seriousness criteria medically significant and intervention required).The patient was treated with surgery (she had surgery to remove the essure,full hysto e-hell eviction).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation and device breakage outcome was unknown.The reporter considered device breakage and device dislocation to be related to essure.The reporter commented: discrepancy in insertion date (b)(6) 2015 and removal date-(b)(6) 2015.Amendment: the report was amended for the following reason: all the information from deletion case (b)(4)was transferred to this case.Reporters, documents and reference section was transferred.No new follow-up information was received from the reporter.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 was reported by a lawyer and describes the occurrence of device dislocation ('migration of implant/infero medial displacement of a medial marker associated with the right insert') and device breakage ('fracturing of the implant') in a 25-year-old female patient who had essure inserted for female sterilisation.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) with pelvic pain and device breakage (seriousness criteria medically significant and intervention required).The patient was treated with surgery (she had surgery to remove the essure,full hysto e-hell eviction).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation and device breakage outcome was unknown.The reporter considered device breakage and device dislocation to be related to essure.No further causality assessment were provided for the product.The reporter commented: discrepancy in insertion date (b)(6) 2015 and removal date-(b)(6) 2015.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-aug-2020: quality safety evaluation of ptc (product technical complaint).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.

• 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: 7056828
• MDR Text Key: 92942035
• Report Number: 2951250-2017-08530
• 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,Followup
• Report Date: 08/19/2020

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: 11/13/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 11/13/2017; 08/11/2020
• Supplement Dates FDA Received: 08/05/2020; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 25 YR