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

Model Number ESS305

Device Problems Break (1069); Biocompatibility (2886); Expulsion (2933); Material Integrity Problem (2978); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Uterine Perforation (2121); Device Embedded In Tissue or Plaque (3165); Fallopian Tube Perforation (4506); Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('one essure perforated a fallopian tube'), embedded device ('a sreange penetratig thing was extracted from the uterus ') and device breakage ('essure fragment persists in the patient ') in a (b)(6) year old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: the patient had no relevant personal medical-surgical history.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2018, the patient experienced complication of device removal ("incomplete extraction of essure "), 8 years 8 months after insertion of essure.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), genital haemorrhage ("excessive bleeding"), hypersensitivity ("allergic reaction "), swelling ("swelling "), pelvic pain ("pelvic pain "), arthralgia ("joint pain"), fatigue ("chronic fatigue"), dyspareunia ("very severe pain during sexual intercourse ") and device expulsion ("device had moved with pieces in the uterus") and was found to have weight increased ("weight gain ").The patient was treated with surgery (device removal and laparoscopic salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the fallopian tube perforation, embedded device, complication of device removal and device expulsion outcome was unknown and the device breakage, genital haemorrhage, hypersensitivity, swelling, pelvic pain, fatigue, weight increased and dyspareunia had not resolved.The reporter considered arthralgia, complication of device removal, device breakage, device expulsion, dyspareunia, embedded device, fallopian tube perforation, fatigue, genital haemorrhage, hypersensitivity, pelvic pain, swelling and weight increased to be related to essure.The reporter commented: after the incomplete extraction, since she still has remains, which is why she is on the waiting list, the symptoms have not yet disappeared.As she is without her tubes, after the final operation that is still pending, she will not have a uterus either, since she has been told that it will be removed.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 fallopian tube perforation ('one essure perforated a fallopian tube'), embedded device ('a sreange penetratig thing was extracted from the uterus') and device breakage ('essure fragment persists in the patient') in a 32-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: the patient had no relevant personal medical-surgical history.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2018, the patient experienced complication of device removal ("incomplete extraction of essure"), 8 years 8 months after insertion of essure.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), genital haemorrhage ("excessive bleeding"), hypersensitivity ("allergic reaction"), swelling ("swelling"), pelvic pain ("pelvic pain"), arthralgia ("joint pain"), fatigue ("chronic fatigue"), dyspareunia ("very severe pain during sexual intercourse") and device expulsion ("device had moved with pieces in the uterus") and was found to have weight increased ("weight gain").The patient was treated with surgery (device removal and laparoscopic salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the fallopian tube perforation, embedded device, arthralgia, complication of device removal and device expulsion outcome was unknown and the device breakage, genital haemorrhage, hypersensitivity, swelling, pelvic pain, fatigue, weight increased and dyspareunia had not resolved.The reporter considered arthralgia, complication of device removal, device breakage, device expulsion, dyspareunia, embedded device, fallopian tube perforation, fatigue, genital haemorrhage, hypersensitivity, pelvic pain, swelling and weight increased to be related to essure.The reporter commented: after the incomplete extraction, since she still has remains, which is why she is on the waiting list, the symptoms have not yet disappeared.As she is without her tubes, after the final operation that is still pending, she will not have a uterus either, since she has been told that it will be removed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-jun-2020: quality safety evaluation of ptc.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 fallopian tube perforation ('one essure perforated a fallopian tube'), embedded device ('a sreange penetratig thing was extracted from the uterus') and device breakage ('essure fragment persists in the patient') in a 32-year-old female patient who had essure (batch no.634985) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included penicillin allergy.The patient had no relevant personal medical-surgical history.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2018, the patient experienced complication of device removal ("incomplete extraction of essure"), 8 years 8 months after insertion of essure.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), genital haemorrhage ("excessive bleeding"), hypersensitivity ("allergic reaction"), swelling ("swelling"), pelvic pain ("pelvic pain"), arthralgia ("joint pain"), fatigue ("chronic fatigue"), dyspareunia ("very severe pain during sexual intercourse") and device expulsion ("device had moved with pieces in the uterus") and was found to have weight increased ("weight gain").The patient was treated with surgery (device removal and laparoscopic salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the fallopian tube perforation, embedded device, arthralgia, complication of device removal and device expulsion outcome was unknown and the device breakage, genital haemorrhage, hypersensitivity, swelling, pelvic pain, fatigue, weight increased and dyspareunia had not resolved.The reporter considered arthralgia, complication of device removal, device breakage, device expulsion, dyspareunia, embedded device, fallopian tube perforation, fatigue, genital haemorrhage, hypersensitivity, pelvic pain, swelling and weight increased to be related to essure.The reporter commented: after the incomplete extraction, since she still has remains, which is why she is on the waiting list, the symptoms have not yet disappeared.As she is without her tubes, after the final operation that is still pending, she will not have a uterus either, since she has been told that it will be removed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-sep-2021: the follow information were updated other health care reporter's, medical history, batch number.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 fallopian tube perforation ('one essure perforated a fallopian tube'), embedded device ('a sreange penetratig thing was extracted from the uterus') and device breakage ('essure fragment persists in the patient') in a 32-year-old female patient who had essure (batch no.634985) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included penicillin allergy.The patient had no relevant personal medical-surgical history.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2018, the patient experienced complication of device removal ("incomplete extraction of essure"), 8 years 8 months after insertion of essure.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), genital haemorrhage ("excessive bleeding"), hypersensitivity ("allergic reaction"), swelling ("swelling"), pelvic pain ("pelvic pain"), arthralgia ("joint pain"), fatigue ("chronic fatigue"), dyspareunia ("very severe pain during sexual intercourse") and device expulsion ("device had moved with pieces in the uterus") and was found to have weight increased ("weight gain").The patient was treated with surgery (device removal and laparoscopic salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the fallopian tube perforation, embedded device, arthralgia, complication of device removal and device expulsion outcome was unknown and the device breakage, genital haemorrhage, hypersensitivity, swelling, pelvic pain, fatigue, weight increased and dyspareunia had not resolved.The reporter considered arthralgia, complication of device removal, device breakage, device expulsion, dyspareunia, embedded device, fallopian tube perforation, fatigue, genital haemorrhage, hypersensitivity, pelvic pain, swelling and weight increased to be related to essure.The reporter commented: after the incomplete extraction, since she still has remains, which is why she is on the waiting list, the symptoms have not yet disappeared.As she is without her tubes, after the final operation that is still pending, she will not have a uterus either, since she has been told that it will be removed.Lot number: 634985, manufacturing date: 2009-04, and expiration date: 2012-04.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 6-sep-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: 10050428
• MDR Text Key: 190749920
• Report Number: 2951250-2020-07086
• 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,foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2021

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 Expiration Date: 04/01/2012
• Device Model Number: ESS305
• Device Lot Number: 634985
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR