BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10194422 · Received June 25, 2020

    Report

    Report Number
    2951250-2020-09517
    Event Type
    Injury
    Date Received
    June 25, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863568) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA, GRAND MULTIPARITY, PELVIC PAIN FEMALE, MENORRHAGIA AND ENDOMETRIAL ABLATION. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY.CYSTOSCOPY.). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: IN EARLIER FOLLOW UP DOB WAS MENTIONED AS (B)(6) 1983 AND IN CURRENT FOLLOW UP ITS MENTIONED AS (B)(6) 1980. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: MULTIPLE FLUOROSCOPIC IMAGES OF THE PELVIS WERE ACQUIRED FOLLOWING PLACEMENT OF BALLOON TIP CATHETER INTO THE UTERUS BY DOCTOR WHO PERFORMED THE PROCEDURE. NEXT, FOLLOWING ADMINISTRATION OF 20 CC OMNIPAQUE 240 VIA THE BALLOON TIP CATHETER, THERE IS NOTED TO BE FILLING OF THE UTERUS AND CERVIX. THE ISTHMIC PORTION OF THE RIGHT FALLOPIAN TUBE APPEARS FILLED. HOWEVER, THERE IS NO APPRECIABLE SPILLAGE OF CONTRAST MATERIAL FROM EITHER FALLOPIAN TUBE INTO THE PERITONEAL SPACE.. LOT NUMBER:863568 MANUFACTURING DATE: 2011-05 EXPIRATION DATE:2014-05 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-AUG-2020: QUALITY-SAFETY EVALUATION OF PTC 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('INCREASINGLY SEVERE PAIN / CHRONIC PELVIC PAIN') AND DEVICE BREAKAGE ('MULTIPLE METAL FRAGMENT OF A SPRING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 838671) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED VULVAL ITCHING AND PARATUBAL CYST. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MEDICAL DEVICE DISCOMFORT ("DISCOMFORT"), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING") AND FATIGUE ("CHRONIC FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD UNDERGONE ESSURE REMOVAL SURGERY, SALPINGECTOMY). ESSURE WAS REMOVED IN (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DEVICE BREAKAGE, MEDICAL DEVICE DISCOMFORT, BACK PAIN, ABDOMINAL PAIN, ABDOMINAL DISTENSION AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BACK PAIN, DEVICE BREAKAGE, FATIGUE, MEDICAL DEVICE DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUL-2020: MR RECEIVED. LOT NUMBER WAS ADDED. NEW EVENT ADDED (FROM MR): MULTIPLE METAL FRAGMENT OF A SPRING. REPORTER ADDED, CONCURRENT CONDITIONS ADDED. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('INCREASINGLY SEVERE PAIN / CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MEDICAL DEVICE DISCOMFORT ("DISCOMFORT"), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), ABDOMINAL DISTENSION ("ABDOMINAL BLOATING") AND FATIGUE ("CHRONIC FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD UNDERGONE ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED IN (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN, MEDICAL DEVICE DISCOMFORT, BACK PAIN, ABDOMINAL PAIN, ABDOMINAL DISTENSION AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, BACK PAIN, FATIGUE, MEDICAL DEVICE DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CAN NOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED THEREFORE NO MEDDRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JUN-2020: PLAINTIFF INFORMATION FORM RECEIVED. THE CASE WAS UPGRADED FROM NON-SERIOUS INCIDENT TO SERIOUS INCIDENT. ESSURE INSERTION AND REMOVAL DATE WERE ADDED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661839 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 838671-NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R