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

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Insufficient Information (3190); Migration (4003)

Patient Problems Pain (1994); Perforation (2001); Uterine Perforation (2121); Heavier Menses (2666); 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 perforation ("perforation"), device breakage ("device fracture") and genital haemorrhage ("abnormal bleeding") in a female patient who had essure inserted.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device breakage (seriousness criteria medically significant and intervention required) and genital haemorrhage (seriousness criterion medically significant).The patient was treated with surgery (to remove the essure implant) and surgery (surgery to remove the essure implant).Essure was removed on (b)(6) 2015.At the time of the report, the perforation, device breakage and genital haemorrhage outcome was unknown.The reporter considered device breakage, genital haemorrhage and perforation 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 uterine perforation ('perforation/migration') and device breakage ('device fracture') in an adult female patient who had essure (batch no.C056r8-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device breakage (seriousness criteria medically significant and intervention required) and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (total hysterectomy, bilateral salpingectomy, oophorectomy).Essure was removed on (b)(6) 2015.At the time of the report, the uterine perforation, device breakage and genital haemorrhage outcome was unknown.The reporter considered device breakage, genital haemorrhage and uterine perforation to be related to essure.The reporter commented: on the left side it was noted that the coil was extruding from the uterine fallopian junction.The lot number reported (c056r8) is not valid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-sep-2020: quality safety evaluation of ptc.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 was reported by a lawyer and describes the occurrence of perforation ('perforation/migration') and device breakage ('device fracture') in an adult female patient who had essure (batch no.C056r8) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device breakage (seriousness criteria medically significant and intervention required) and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (total hysterectomy, bilateral salpingectomy, oopherectomy).Essure was removed on (b)(6) 2015.At the time of the report, the perforation, device breakage and genital haemorrhage outcome was unknown.The reporter considered device breakage, genital haemorrhage and perforation to be related to essure.The reporter commented: on the left side it was noted that the coil was extruding from the uterine fallopian junction.Most recent follow-up information incorporated above includes: on (b)(6) 2020: mr received: lot number and rcc note, reporters were added.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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ('perforation/migration') and device breakage ('device fracture') in an adult female patient who had essure (batch no.C056r8-not valid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device breakage (seriousness criteria medically significant and intervention required) and genital haemorrhage ("abnormal bleeding").The patient was treated with surgery (total hysterectomy, bilateral salpingectomy, oophorectomy).Essure was removed on (b)(6) 2015.At the time of the report, the perforation, device breakage and genital haemorrhage outcome was unknown.The reporter considered device breakage, genital haemorrhage and perforation to be related to essure.The reporter commented: on the left side it was noted that the coil was extruding from the uterine fallopian junction.The lot number reported (c056r8) is not valid.Most recent follow-up information incorporated above includes: on 10-sep-2020: update of information (batch is not valid).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: 7073933
• MDR Text Key: 93420902
• Report Number: 2951250-2017-09512
• 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,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Model Number: ESS305
• Device Lot Number: C056R8-NOT VALID
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention