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

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Insufficient Information (4580)

Event Date 01/25/2018

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain"), device breakage ("part of the product remained") and complication of device removal ("part of the product remained") in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.In 2009, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria disability, medically significant and intervention required), swelling ("swelling"), metrorrhagia ("metrorrhagia"), the first episode of fatigue ("fatigue"), the second episode of fatigue ("chronic tiredness"), dysgeusia ("metal mouth taste"), insomnia ("insomnia"), headache ("headache"), back pain ("lumbar pain"), groin pain ("cramp in the groin"), abdominal pain ("abdominal pain") and unevaluable event ("esthetic damage").Patient was treated with essure removal on (b)(6) 2018; however, during removal, patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal (seriousness criteria medically significant and intervention required).As treatment she underwent another surgery on (b)(6) 2018.At the time of the report, the pelvic pain, device breakage, complication of device removal, swelling, metrorrhagia, the last episode of fatigue, dysgeusia, insomnia, headache, back pain, groin pain, abdominal pain and unevaluable event outcome was unknown.The reporter considered abdominal pain, back pain, complication of device removal, device breakage, dysgeusia, groin pain, headache, insomnia, metrorrhagia, pelvic pain, swelling, unevaluable event, the first episode of fatigue and the second episode of fatigue to be related to essure.No lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformances 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') and device breakage ('part of the product remained') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "part of the product remained" (seriousness criterion intervention required) on (b)(6) 2018.In 2009, the patient had essure inserted.On (b)(6) 2018, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain (seriousness criteria disability and intervention required), swelling ("swelling"), intermenstrual bleeding ("metrorrhagia"), fatigue ("fatigue"), chronic fatigue ("chronic tiredness"), dysgeusia ("metal mouth taste"), insomnia ("insomnia"), headache ("headache"), back pain ("lumbar pain"), groin pain ("cramp in the groin"), abdominal pain ("abdominal pain") and unevaluable event ("esthetic damage nos").The patient was treated with surgery (essure removal and surgery on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, device breakage, swelling, intermenstrual bleeding, fatigue, chronic fatigue, dysgeusia, insomnia, headache, back pain, groin pain, abdominal pain and unevaluable event outcome was unknown.The reporter considered abdominal pain, back pain, device breakage, dysgeusia, fatigue, groin pain, headache, insomnia, intermenstrual bleeding, pelvic pain, swelling, unevaluable event and chronic fatigue to be related to essure.Most recent follow-up information incorporated above includes: on 21-mar-2022: no new clinical information received, update to imdrf/fda codes only.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') and device breakage ('part of the product remained') in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "part of the product remained" (seriousness criterion intervention required) on (b)(6) 2018.In 2009, the patient had essure inserted.On (b)(6) 2018, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain (seriousness criteria disability and intervention required), swelling ("swelling"), intermenstrual bleeding ("metrorrhagia"), fatigue ("fatigue"), chronic fatigue ("chronic tiredness"), dysgeusia ("metal mouth taste"), insomnia ("insomnia"), headache ("headache"), back pain ("lumbar pain"), groin pain ("cramp in the groin"), abdominal pain ("abdominal pain") and unevaluable event ("esthetic damage nos").The patient was treated with surgery (essure removal and surgery on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, device breakage, swelling, intermenstrual bleeding, fatigue, chronic fatigue, dysgeusia, insomnia, headache, back pain, groin pain, abdominal pain and unevaluable event outcome was unknown.The reporter considered abdominal pain, back pain, device breakage, dysgeusia, fatigue, groin pain, headache, insomnia, intermenstrual bleeding, pelvic pain, swelling, unevaluable event and chronic fatigue to be related to essure.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 12-apr-2022: 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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj, NJ 07981
• MDR Report Key: 8245672
• MDR Text Key: 132987720
• Report Number: 2951250-2019-00333
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2022

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 Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 03/21/2022; 04/12/2022
• Supplement Dates FDA Received: 03/29/2022; 04/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Sex: Female