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

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Anemia (1706); Fatigue (1849); Pain (1994); Heavier Menses (2666); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2011

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm (reference number: (b)(4)) on 12-jun-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("hemorrhagic menses") and device breakage ("one of the implants broke during bilateral salpingectomy") in a female patient who had essure (batch no.816055) inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2011, the patient had essure inserted.On the same day, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required).On (b)(6) 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("complication of device removal").On an unknown date, the patient experienced anaemia ("chronic anemia"), fatigue ("abnormally intense fatigue") and pelvic pain ("pelvic pain").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2017) and surgery (piece was removed).Essure was removed on (b)(6) 2017.At the time of the report, the menorrhagia, device breakage, complication of device removal, anaemia, fatigue and pelvic pain outcome was unknown.The reporter considered anaemia, complication of device removal, device breakage, fatigue, menorrhagia and pelvic pain to be related to essure.The reporter commented: the broken piece during removal was removed and is supposedly complete, but she will need to undergo an abdominal x-ray to be certain that everything is ok.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 14-jun-2017 for the following meddra preferred terms: device breakage.The analysis in the global safety database revealed 1639 cases.Menorrhagia.The analysis in the global safety database revealed 400 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Company causality comment: incident.At the time of reporting, 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 case was initially received via regulatory authority ansm (reference number: (b)(4)) on 12-jun-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("hemorrhagic menses") and device breakage ("one of the implants broke during bilateral salpingectomy") in a female patient who had essure (batch no.(b)(4)) inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2011, the patient had essure inserted.On the same day, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required).On (b)(6) 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("complication of device removal").On an unknown date, the patient experienced anaemia ("chronic anemia"), fatigue ("abnormally intense fatigue") and pelvic pain ("pelvic pain").The patient was treated with surgery (bilateral salpingectomy on (b)(6) 2017 and piece was removed).Essure was removed on (b)(6) 2017.At the time of the report, the menorrhagia, device breakage, complication of device removal, anaemia, fatigue and pelvic pain outcome was unknown.The reporter considered anaemia, complication of device removal, device breakage, fatigue, menorrhagia and pelvic pain to be related to essure.The reporter commented: the broken piece during removal was removed and is supposedly complete, but she will need to undergo an abdominal x-ray to be certain that everything is ok.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(4) 2017 for the following meddra preferred terms: device breakage.The analysis in the global safety database revealed 1649 cases.Menorrhagia.The analysis in the global safety database revealed 407 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.Most recent follow-up information incorporated above includes: on (b)(4) 2017: quality safety evaluation of ptc.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 12-jun-2017.The most recent information was received on 27-may-2019.This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ('pelvic pain') and device breakage ('one of the implants broke during bilateral salpingectomy') in a 41-year-old female patient who had essure (batch no.816055) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included appendectomy, pollen allergy and allergy to animals.The patient had no concurrent non-gynecological conditions.Concurrent conditions included menorrhagia.In 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In (b)(6) 2011, the patient had essure inserted.On (b)(6) 2017, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("complication of device removal / persistence of two resifues on right side").On an unknown date, the patient experienced dysmenorrhoea ("painful menstruation since removal of essure"), anaemia ("chronic anemia") and fatigue ("abnormally intense fatigue").The patient was treated with surgery (bilateral salpingectomy and piece was removed).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, device breakage, dysmenorrhoea, complication of device removal, anaemia and fatigue outcome was unknown.The reporter considered anaemia, complication of device removal, device breakage, dysmenorrhoea, fatigue and pelvic pain to be related to essure.The reporter commented: the broken piece during removal was removed and is supposedly complete, but she will need to undergo an abdominal x-ray to be certain that everything is ok.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 19.6 kg/sqm.Further company follow-up with the consumer is not possible.Most recent follow-up information incorporated above includes: on 27-may-2019: as per information received from the french health authorities, case (b)(4) (legacy device report num 2951250-2019-01946) was identified as a duplicate of this case.All the information from deleted case (b)(4) has been transferred to this case.New reporters added; patient¿s demographic details and medical history provided; event menorrhagia was deleted as it was reported as concurrent condition; painful menstruation since removal of essure was added as event.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this 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: 6653644
• MDR Text Key: 78020367
• Report Number: 2951250-2017-02251
• 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,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2019

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 Expiration Date: 01/01/2014
• Device Model Number: ESS305
• Device Lot Number: 816055
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 06/20/2017
• Supplement Dates Manufacturer Received: 07/11/2017; 05/27/2019
• Supplement Dates FDA Received: 07/20/2017; 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 52