BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3952350 · Received July 17, 2014

    Report

    Report Number
    2951250-2014-00232
    Date Received
    July 17, 2014
    Date of Event
    May 9, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION RECEIVED ON (B)(6)-2014: THIS CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT. IT WAS REPORTED THAT PATIENT MEDICAL HISTORY INCLUDED A DELIVERY ON (B)(6)-2014. ESSURE, EXPIRATION DATE OCT-2016, WAS INSERTED 16 WEEKS POSTPARTUM. CERVICAL DILATATION WAS APPLIED AND VERSED AND DIPRIVAN WERE GIVEN DURING INSERTION. PHYSICIAN CONSIDERED BOTH THE PROCEDURE, WHICH TOOK LESS THAN 20 MINUTES, AND THE VISUALIZATION OF THE TUBAL OSTIUM BOTH SIDES EASY. NO FLUID LOSS MORE THAN 1500CC DURING HYSTEROSCOPY. ON (B)(6)-2014 THE CONFIRMATION OF ESSURE PLACEMENT WAS PERFORMED VIA ULTRASOUND, WHICH SHOWED THAT BOTH COILS WERE IN PLACE. CONDOMS WERE USED AS BACK-UP CONTRACEPTION AFTER ESSURE INSERTION AND BEFORE TOTAL OCCLUSION CONFIRMATION. NO HYSTEROSALPINGOGRAM (HSG) WAS PERFORMED. PERFORATION DID NOT OCCUR. ON (B)(6)-2014 PATIENT WAS HOSPITALIZED AND BOTH COILS WERE SURGICALLY REMOVED BY HYSTEROSCOPY AND LAPAROSCOPY. SHE REQUESTED THE REMOVAL DUE TO PAIN AND RASH; APPARENT ALLERGIC REACTION. DURING SURGERY IT WAS OBSERVED THAT BOTH DEVICES WERE IN CORRECT POSITION. SALPINGECTOMY WAS PERFORMED FOR STERILIZATION. SHE WAS DISCHARGED ON THE SAME DAY. PATHOLOGY TESTS WERE PERFORMED AND THE RESULTS SHOWED MARKED ACUTE AND CHRONIC SALPINGITIS. CURRENTLY SHE WAS ASYMPTOMATIC AND DOING WELL, BUT PHYSICIAN BELIEVED THAT SHE HAD LIKELY ALLERGIC REACTION TO COILS. NO FURTHER INFORMATION WAS PROVIDED. PTC INVESTIGATION RESULT RECEIVED ON (B)(6)-2014: PTC GLOBAL NUMBER: (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT AT THIS TIME. MEDICAL ASSESSMENT: THE MEDICAL EVENTS REPORTED ARE POSSIBLE UNDESIRABLE EVENTS WITH THE USE OF ESSURE AND NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. FOUR (4) ADDITIONAL AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER B82480 BUT NONE OF THESE CASES REFER TO A SIMILAR TYPE OF MEDICAL EVENT. NO BATCH SIGNAL COULD BE IDENTIFIED AT THIS TIME. THE REVIEW OF THE LOT HISTORY RECORDS CONFIRMED THAT THE PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A GYNECOLOGIST/OBSTETRICIAN IN UNITED STATES ON (B)(6)-2014 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED ABDOMINAL PAIN, BLEEDING, AND RASH. NO INFORMATION GIVEN ON PATIENT'S HISTORY, PAST DRUGS AND CONCURRENT CONDITIONS. IT WAS NOT REPORTED WHETHER THE PATIENT RECEIVED ANY CONCOMITANT MEDICATION. ON (B)(6)-2014 THE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED, LOT NUMBER B82480, FOR STERILIZATION. ON (B)(6)-2014, THE PATIENT SAW HER HEALTH CARE PROFESSIONAL FOR BLEEDING, ABDOMINAL PAIN, AND RASH. AN ULTRASOUND WAS DONE, RESULTS NOT REPORTED. ON (B)(6) 2014, ESSURE WAS REMOVED BILATERALLY AND BOTH FALLOPIAN TUBES. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN ABDOMINAL PAIN, BLEEDING, AND RASH AND ESSURE IS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419306 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B82480

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other