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

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of device dislocation ("suggests a slight displacement of a component") in a 36 year-old female patient who had essure inserted (lot no.C49139) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of lower abdominal discomfort on (b)(6) 2019, uti on (b)(6) 2019, respiratory tract infection and cystitis on (b)(6) 2019, ovarian pain on (b)(6) 2018, vulval lesion (painful stinging lesions in the vulva) on (b)(6) 2018, anxiety and dizziness on (b)(6) 2017 and paresthesia on (b)(6) 2016.The only concomitant product mentioned was ibuprofen.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the day of essure insertion, she experienced abdominal pain ("chronic abdominal pain"), suprapubic pain ("discomfort in the suprapubic area radiating to the leg"), back pain ("lumbar pain"), headache ("headache"), arthralgia ("hip pain / joint pain"), fatigue ("fatigue") and alopecia ("alopecia").Essure was removed on (b)(6) 2019.An unknown time she experienced device dislocation (seriousness criteria hospitalisation and intervention required) and abdominal pain lower ("intense pain in the iliac fossa").The patient was hospitalised from (b)(6) 2019.The patient was treated with surgery (laparoscopic bilateral salpingectomy and device extraction).At the time of the report, the outcome of device dislocation was unknown.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, back pain, device dislocation, fatigue, headache and suprapubic pain to be related to essure administration.The reporter commented: despite the mobilization / defective placement of the device being evident already in 2015, and again in 2018 and its symptoms, it was not until (b)(6) 2019 that essure was withdrawn.It is indicated that she was admitted due to pain due to prostheses, implants and genitourinary grafts, initial contact.Procedures: fallopian tube removal, intraluminal device, percutaneous endoscopic approach.Damage: acquired absence of another genital organ.Reason: malpractice.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 76 kg.[hysterosalpingogram] on (b)(6) 2015: tests left essure placement.[ultrasound scan] in (b)(6) 2015: verification of device normo-insertion 3 months after insertion procedure.[x-ray] on (b)(6) 2018: a millimeter metal particle superimposed on the one on the side, suggesting a slight displacement of a component.Batch no: c49139, production date: 2014-04-09, expiration date: 2017-04-30.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 04-aug-2023: plaintiff fact sheet and medical record received.Case became serious incident.Event injury replaced with event device dislocation.New events added: suprapubic pain, joint pain, abdominal pain, back pain, headache, hip pain, fatigue, alopecia.Essure removal surgery and details added.New reporter and patient details updated.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.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of device dislocation ("suggests a slight displacement of a component") in a 36 year-old female patient who had essure inserted (lot no.C49139) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of lower abdominal discomfort on (b)(6) 2019, uti on (b)(6) 2019, respiratory tract infection and cystitis on (b)(6) 2019, ovarian pain on (b)(6) 2018, vulval lesion (painful stinging lesions in the vulva) on (b)(6) 2018, anxiety and dizziness on (b)(6) 2017 and paresthesia on (b)(6) 2016.The only concomitant product mentioned was ibuprofen.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, the day of essure insertion, she experienced abdominal pain ("chronic abdominal pain"), suprapubic pain ("discomfort in the suprapubic area radiating to the leg"), back pain ("lumbar pain"), headache ("headache"), arthralgia ("hip pain / joint pain"), fatigue ("fatigue") and alopecia ("alopecia").Essure was removed on (b)(6) 2019.An unknown time later she experienced device dislocation (seriousness criteria hospitalisation and intervention required) and abdominal pain lower ("intense pain in the iliac fossa").The patient was hospitalised from (b)(6) 2019 to (b)(6) 2019.The patient was treated with surgery (laparoscopic bilateral salpingectomy and device extraction).At the time of the report, the outcome of device dislocation was unknown.The reporter considered abdominal pain, abdominal pain lower, alopecia, arthralgia, back pain, device dislocation, fatigue, headache and suprapubic pain to be related to essure administration.The reporter commented: despite the mobilization / defective placement of the device being evident already in 2015, and again in 2018 and its symptoms, it was not until (b)(6) 2019 that essure was withdrawn.It is indicated that she was admitted due to pain due to prostheses, implants and genitourinary grafts, initial contact.Procedures: fallopian tube removal, intraluminal device, percutaneous endoscopic approach.Damage: acquired absence of another genital organ.Reason: malpractice.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 76 kg.[hysterosalpingogram] on (b)(6) 2015: tests left essure placement.[ultrasound scan] in (b)(6) 2015: verification of device normo-insertion 3 months after insertion procedure.[x-ray] on (b)(6) 2018: a millimeter metal particle superimposed on the one on the side, suggesting a slight displacement of a component.Batch no: c49139.Production date: 2014-04-09 expiration date: 2017-04-30.Quality-safety evaluation of ptc: for essure: 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.The most recent follow-up information incorporated above includes data received on: 18-aug-2023: 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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 17507862
• MDR Text Key: 321055533
• Report Number: 2951250-2023-02786
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: ESS305
• Device Lot Number: C49139
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2023
• Date Device Manufactured: 04/09/2014
• 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
• Treatment: IBUPROFEN; IBUPROFEN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 76 KG