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

Model Number ESS305

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Anemia (1706); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Rash (2033); Abnormal Vaginal Discharge (2123); Weight Changes (2607); 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 pelvic pain ('chronic pelvic pain') and genital haemorrhage ('bleeding') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included menorrhagia, uterine bleeding, fatigue, anemia and vaginal discharge.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia"), migraine ("migraines") and rash ("rashes") and was found to have weight increased ("weight gain").The patient was treated with surgery (ablation and laparoscopic bilateral salpingectomy with bilateral cornual wedge resection).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, genital haemorrhage, dyspareunia, migraine, rash and weight increased outcome was unknown.The reporter considered dyspareunia, genital haemorrhage, migraine, pelvic pain, rash and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: bilateral essure devices are intact.There is no free spillage of contrast noted in the peritoneal cavity.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 ('chronic pelvic pain') and genital haemorrhage ('bleeding') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included menorrhagia, uterine bleeding, fatigue, anemia and vaginal discharge.On (b)(6)2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia"), migraine ("migraines") and rash ("rashes") and was found to have weight increased ("weight gain").The patient was treated with surgery (ablation and laparoscopic bilateral salpingectomy with bilateral cornual wedge resection).Essure was removed on (b)(6)2019.At the time of the report, the pelvic pain, genital haemorrhage, dyspareunia, migraine, rash and weight increased outcome was unknown.The reporter considered dyspareunia, genital haemorrhage, migraine, pelvic pain, rash and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6)2009: bilateral essure devices are intact.There is no free spillage of contrast noted in the peritoneal cavity.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-feb-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 device breakage ('each fallopian tube contains a metal, cylindrical fragment of hard ware'), pelvic pain ('chronic pelvic pain') and genital haemorrhage ('bleeding') in an adult female patient who had essure (batch no.619616) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included menorrhagia, uterine bleeding, fatigue, anemia and vaginal discharge.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia"), migraine ("migraines") and rash ("rashes") and was found to have weight increased ("weight gain").The patient was treated with surgery (ablation and laparoscopic bilateral salpingectomy with bilateral cornual wedge resection).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, dyspareunia, migraine, rash and weight increased outcome was unknown.The reporter considered device breakage, dyspareunia, genital haemorrhage, migraine, pelvic pain, rash and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: bilateral essure devices are intact.There is no free spillage of contrast noted in the peritoneal cavity.Most recent follow-up information incorporated above includes: on 9-jul-2020: mr received :lot no and reporter information added.New event added:device breakage.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 device breakage ('each fallopian tube contains a metal, cylindrical fragment of hard ware'), pelvic pain ('chronic pelvic pain') and genital haemorrhage ('bleeding') in an adult female patient who had essure (batch no.619616) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included menorrhagia, uterine bleeding, fatigue, anemia and vaginal discharge.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia"), migraine ("migraines") and rash ("rashes") and was found to have weight increased ("weight gain").The patient was treated with surgery (ablation and laparoscopic bilateral salpingectomy with bilateral cornual wedge resection).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, pelvic pain, genital haemorrhage, dyspareunia, migraine, rash and weight increased outcome was unknown.The reporter considered device breakage, dyspareunia, genital haemorrhage, migraine, pelvic pain, rash and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: bilateral essure devices are intact.There is no free spillage of contrast noted in the peritoneal cavity.Lot number:619616 manufacturing date: 2009/02 expiration date: 2012/02.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-aug-2020: 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: 9568872
• MDR Text Key: 187266077
• Report Number: 2951250-2020-00337
• 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: 08/17/2020

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: 02/01/2012
• Device Model Number: ESS305
• Device Lot Number: 619616
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 12/19/2019; 07/09/2020; 08/05/2020
• Supplement Dates FDA Received: 02/18/2020; 08/03/2020; 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention