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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Anemia (1706); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Perforation (2001); Scarring (2061); Uterine Perforation (2121); Heavier Menses (2666); Genital Bleeding (4507)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (fda, reference number: mw5077440) on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of uterine perforation ("constant repuncturing of my uterus") and genital haemorrhage ("continuous heavy bleeding") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida and parity 2 (she inserted essure after having her 2nd son).Concomitant products included alprazolam (xanax), fluoxetine hydrochloride (prozac) and topiramate (topamax).On an unknown date, the patient had essure inserted.On (b)(6) 2012, the patient experienced uterine pain ("constant re-puncturing of uterus").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and congenital anomaly), genital haemorrhage (seriousness criteria medically significant and intervention required), migraine ("debilitating migraines"), anaemia ("severe anemia"), scar ("excessive scar tissue") and abdominal adhesions ("essure caused the bladder and colon to fuse to uterus").The patient was treated with surgery (total abdominal hysterectomy) and surgery (total abdominal hysterectomy).Essure was removed.In 2013, the genital haemorrhage had resolved.At the time of the report, the uterine pain, migraine, anaemia, scar and abdominal adhesions outcome was unknown.The reporter considered abdominal adhesions, anaemia, genital haemorrhage, migraine, scar, uterine pain and uterine perforation to be related to essure.The reporter commented: that she had a serious injury (required intervention and other serious important medical event) but did not specify it to one of the events.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

E was initially received via regulatory authority (fda, reference number: mw5077440) on 04-jun-2018.The most recent information was received on 21-nov-2018.This spontaneous case was reported by a consumer and describes the occurrence of uterine perforation ("constant repuncturing of my uterus") and genital haemorrhage ("continuous heavy bleeding") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida and parity 2 (she inserted essure after having her 2nd son).Concomitant products included alprazolam (xanax), fluoxetine hydrochloride (prozac) and topiramate (topamax).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced uterine pain ("constant re-puncturing of uterus").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), migraine ("debilitating migraines"), anaemia ("severe anemia"), scar ("excessive scar tissue") and abdominal adhesions ("essure caused the bladder and colon to fuse to uterus").The patient was treated with surgery (total abdominal hysterectomy) and surgery (total abdominal hysterectomy).Essure was removed on 22-feb-2013.In 2013, the genital haemorrhage had resolved.At the time of the report, the uterine perforation, uterine pain, migraine, anaemia, scar and abdominal adhesions outcome was unknown.The reporter considered abdominal adhesions, anaemia, genital haemorrhage, migraine, scar, uterine pain and uterine perforation to be related to essure.The reporter commented: that she had a serious injury (required intervention and other serious important medical event) but did not specify it to one of the events.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 21-nov-2018: quality safety evaluation of ptc 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 case was initially received via regulatory authority (fda, reference number: mw5077440) on 04-jun-2018.The most recent information was received on 19-apr-2021.This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('constant repuncturing of my uterus / migrated'), device dislocation ('migrated from position') and genital haemorrhage ('continuous heavy bleeding') in a 30-year-old female patient who had essure (batch no.919039) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida and parity 2 (she inserted essure after having her 2nd son).Concomitant products included alprazolam (xanax), fluoxetine hydrochloride (prozac) and topiramate (topamax).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced uterine pain ("constant re-puncturing of uterus").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), migraine ("debilitating migraines"), anaemia ("severe anemia"), scar ("excessive scar tissue") and abdominal adhesions ("essure caused the bladder and colon to fuse to uterus").The patient was treated with surgery (total abdominal hysterectomy, total abdominal hysterectomy and bilateral salpingectomy and total abdominal hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2013.In 2013, the genital haemorrhage had resolved.At the time of the report, the uterine perforation, device dislocation, uterine pain, migraine, anaemia, scar and abdominal adhesions outcome was unknown.The reporter considered abdominal adhesions, anaemia, device dislocation, genital haemorrhage, migraine, scar, uterine pain and uterine perforation to be related to essure.The reporter commented: that she had a serious injury (required intervention and other serious important medical event) but did not specify it to one of the events.Date(s) of insertion: (b)(6) 2012.Date(s) of removal: (b)(6) 2013 (discrepancy noted).Most recent follow-up information incorporated above includes: on 19-apr-2021: mr received: lot number, event device migrated added.Reporter information, rcc note added.Incident: 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 uterine perforation ('constant repuncturing of my uterus / migrated'), device dislocation ('migrated from position') and genital haemorrhage ('continuous heavy bleeding') in a 30-year-old female patient who had essure (batch no.919039) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida and parity 2 (she inserted essure after having her 2nd son).Concomitant products included alprazolam (xanax), fluoxetine hydrochloride (prozac) and topiramate (topamax).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced uterine pain ("constant re-puncturing of uterus").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), migraine ("debilitating migraines"), anaemia ("severe anemia"), scar ("excessive scar tissue") and abdominal adhesions ("essure caused the bladder and colon to fuse to uterus").The patient was treated with surgery (total abdominal hysterectomy, total abdominal hysterectomy and bilateral salpingectomy and total abdominal hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2013.In 2013, the genital haemorrhage had resolved.At the time of the report, the uterine perforation, device dislocation, uterine pain, migraine, anaemia, scar and abdominal adhesions outcome was unknown.The reporter considered abdominal adhesions, anaemia, device dislocation, genital haemorrhage, migraine, scar, uterine pain and uterine perforation to be related to essure.The reporter commented: that she had a serious injury (required intervention and other serious important medical event) but did not specify it to one of the events.Date(s) of insertion: (b)(6) 2012 date(s) of removal: (b)(6) 2013, (b)(6) 2013(discrepancy noted).Lot number: 919039 manufacturing date: 2011-11 expiration date: 2014-11 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 incident 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.

• 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: 7618054
• MDR Text Key: 111637575
• Report Number: 2951250-2018-02699
• 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: 05/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2014
• Device Model Number: ESS305
• Device Lot Number: 919039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROZAC; PROZAC; PROZAC; PROZAC; TOPAMAX; TOPAMAX; TOPAMAX; TOPAMAX; XANAX; XANAX; XANAX; XANAX; PROZAC; TOPAMAX; XANAX
• Patient Outcome(s): Congenital Anomaly; Other; Required Intervention
• Patient Age: 30 YR