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

Model Number ESS305

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2016

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("medical device removal") in an adult female patient who had essure inserted.There was no information on the patient's medical history or concurrent conditions.On (b)(6)2009, the patient had essure inserted.Essure was removed on (b)(6)2016.An unknown time later she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (hysterectomy - uterus).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: plantiff will talk to her doctor about partial hysterectomy.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 02-may-2023: previously reported event "adverse event nos: updated to "medical device removal",reporter lawyer added, reference section, non drug treatment updated.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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("medical device removal") in a 29 year-old female patient who had essure inserted for female sterilisation.The patient had a medical history of overweight, menorrhagia, dyspareunia, heavy periods, parity 1, gravida ii, abnormal uterine bleeding and pelvic pain.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2016, 2870 days after essure insertion and 314 days after its most recent use, she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (robotic-assisted total laparoscopic hysterectomy, bilateral salpingo-oophorectomy).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: plantiff will talk to her doctor about partial hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 26.172 kg/sqm.[pathology test] on (b)(6) 2016: tissues: uterus with or without tubes & ovaries-not neoplastic or prolapse - uterus, cervix, bilateral fallopian tubes.Diagnosis: uterus and cervix, bilateral fallopian tubes, hysterectomy and bilateral salpingectomy: uterus and cervix (78 grams): proliferative endometrium; moderate superficial adenomyosis; no morphologic evidence of leiomyomas or endometrial polyps; moderate chronic cervicitis with squamous metaplasia; no evidence of malignancy or hyperplasia.Fallopian tube, right, salpingectomy: status post prior tubal ligation; small paratubal cyst.Clinical information: chronic pelvic pain, hypermenorrhea, tubular ligation status.Gross description: there is a coiled wire extending into the uterus from the fallopian tube.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 07-nov-2023: reporters, patient information, medical history, lab data, indication, non drug treatment, event onset date adedd.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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 17006508
• MDR Text Key: 315970578
• Report Number: 2951250-2023-02515
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 67 KG