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

Model Number ESS305

Device Problems Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain'), device breakage ('essure fracture') and complication of device removal ('failed removal surgery') in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), complication of device removal (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), haemorrhage ("general abnormal bleeding"), psychological trauma ("psych injury") and urinary tract infection ("urinary tract infection").The patient was treated with surgery (salpingectomy - bilateral).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, device breakage, complication of device removal, abdominal pain, haemorrhage, psychological trauma and urinary tract infection had resolved.The reporter considered abdominal pain, complication of device removal, device breakage, haemorrhage, pelvic pain, psychological trauma and urinary tract infection to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-may-2020: invalid case validated; patient information updated; product information updated; adverse events added to case: "pelvic pain"; "abdominal pain"; "bleeding nos"; "psychological trauma"; "urinary tract infection"; "device breakage"; "complication of device removal".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 pelvic pain ('pelvic pain'), device breakage ('essure fracture') and complication of device removal ('failed removal surgery') in a 25-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), complication of device removal (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), haemorrhage ("general abnormal bleeding"), psychological trauma ("psych injury") and urinary tract infection ("urinary tract infection").The patient was treated with surgery (salpingectomy - bilateral).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, device breakage, complication of device removal, abdominal pain, haemorrhage, psychological trauma and urinary tract infection had resolved.The reporter considered abdominal pain, complication of device removal, device breakage, haemorrhage, pelvic pain, psychological trauma and urinary tract infection 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 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain'), device breakage ('essure fracture') and complication of device removal ('failed removal surgery') in a 25-year-old female patient who had essure (batch no.20227513) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included ovarian cyst, paratubal cyst, peripheral swelling, bowel motility disorder, uterine bleeding, sore throat, urinary tract infection, headache, urinary frequency, back pain, acute bronchitis and uterine dilation and curettage.Previously administered products included for an unreported indication: keflex and cipro.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), complication of device removal (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), genital haemorrhage ("general abnormal bleeding"), psychological trauma ("psych injury") and urinary tract infection ("urinary tract infection").The patient was treated with surgery (salpingectomy - bilateral).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, device breakage, complication of device removal, abdominal pain, genital haemorrhage, psychological trauma and urinary tract infection had resolved.The reporter considered abdominal pain, complication of device removal, device breakage, genital haemorrhage, pelvic pain, psychological trauma and urinary tract infection to be related to essure.The reporter commented: discrepancy noted: essure insertion date as per mr is (b)(6) 2010.Left : 6 coils.Right: the number of expanded coils that appeared trailing to the uterine cavity on this side was 4.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram pelvis - on (b)(6) 2014: there is a punctate metallic foreign body within the left uterine cornua there is a curvilinear metallic device within the right adnexa extending from the cornua into the periuterine tissues.These metallic foreign bodies are likely related to remnants of the essure coils.There is no evidence of an abscess, drainable hematoma, or bowel injury.The adjacent sigmoid colon and rectum are unremarkable.Most recent follow-up information incorporated above includes: on 20-apr-2021: mr received: reporter, lot number, medical history, historical drug, lab test and rcc 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 pelvic pain ('pelvic pain'), device breakage ('essure fracture') and complication of device removal ('failed removal surgery') in a 25-year-old female patient who had essure (batch no.20227513) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included ovarian cyst, paratubal cyst, peripheral swelling, bowel motility disorder, uterine bleeding, sore throat, urinary tract infection, headache, urinary frequency, back pain, acute bronchitis and uterine dilation and curettage.Previously administered products included for an unreported indication: keflex and cipro.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), complication of device removal (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), genital haemorrhage ("general abnormal bleeding"), psychological trauma ("psych injury") and urinary tract infection ("urinary tract infection").The patient was treated with surgery (salpingectomy - bilateral).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, device breakage, complication of device removal, abdominal pain, genital haemorrhage, psychological trauma and urinary tract infection had resolved.The reporter considered abdominal pain, complication of device removal, device breakage, genital haemorrhage, pelvic pain, psychological trauma and urinary tract infection to be related to essure.The reporter commented: discrepancy noted: essure insertion date as per mr is (b)(6) 2010.Left : 6 coils right: the number of expanded coils that appeared trailing to the uterine cavity on this side was 4.Diagnostic results (normal ranges are provided in parenthesis if available): computerised tomogram pelvis - on (b)(6) 2014: there is a punctate metallic foreign body within the left uterine cornua there is a curvilinear metallic device within the right adnexa extending from the cornua into the periuterine tissues.These metallic foreign bodies are likely related to remnants of the essure coils.There is no evidence of an abscess, drainable hematoma, or bowel injury.The adjacent sigmoid colon and rectum are unremarkable.Lot number: 20227513 manufacturing date: 2009-12 expiration date: 2012-12.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 3-may-2021: quality safety evaluation of ptc we received a lot number in this case.A technical investigation was 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.

• 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: 10075616
• MDR Text Key: 191585656
• Report Number: 2951250-2020-07966
• 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: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2012
• Device Model Number: ESS305
• Device Lot Number: 20227513
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 25 YR