BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3952330 · Received July 18, 2014

    Report

    Report Number
    2951250-2014-00241
    Date Received
    July 18, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING. THE CODE (B)(4) WAS REPLACED WITH (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFO WAS RECEIVED ON (B)(4) 2014: ON (B)(6) 2014, ESSURE DEVICE DID NOT RELEASE FROM CATHETER. WHEN DOCTOR TRIED TO REMOVE CATHETER, IT STRETCHED AND BROKE (PREVIOUSLY REPORTED AS COIL IN PLACE BUT CATHETER ALSO STILL IN PATIENT), LEAVING THE DISTAL PORTION OF THE CATHETER STUCK TO THE ESSURE COIL STILL IN PLACE IN THE UTERUS. NO FURTHER INFORMATION WAS PROVIDED. PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(4) 2014: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (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, THE OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL ARE WITHIN MANUFACTURING SPECIFICATIONS. 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: THIS CASE REPORTED ISSUES WITH DEPLOYMENT IN TERMS OF THE DETACHMENT OF THE CATHETER AND BREAKAGE IN THAT THE CATHETER APPEARS TO HAVE REMAIN ATTACHED TO THE COIL. THESE EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. ONE (1) ADDITIONAL AE CASE REPORT HAS BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER B94873 BUT THIS CASE DID NOT REFER TO A SIMILAR TYPE OF DEPLOYMENT OR BREAKAGE 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. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND WHEN THE DOC TRIED TO REMOVE THE CATHETER, IT STRETCHED AND BROKE (PREVIOUSLY REPORTED AS COIL IN PLACE BUT CATHETER ALSO STILL IN PATIENT)/COMPLICATION OF DEVICE INSERTION AND CATHETER DID NOT SEPARATE FROM THE DISTAL PORTION OF COIL. ALL EVENTS ARE CONSIDERED NON-SERIOUS. THE EVENT: WHEN THE DOC TRIED TO REMOVE THE CATHETER, IT STRETCHED AND BROKE, WAS INTERPRETED AS A DEVICE HANDLING ERROR (STRETCHED) AND DEVICE BREAKAGE; THIS BREAKAGE IS UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE AND WAS REGARDED AS NEAR-INCIDENT AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. THE REMAINING EVENTS ARE LISTED AND NON­ INCIDENTS. DURING DIFFICULT INSERTIONS,SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, IT WAS ONLY MENTIONED THAT THE CATHETER DID NOT SEPARATE FROM THE DISTAL PORTION OF COIL. WHEN DOCTOR TRIED TO REMOVE CATHETER, IT STRETCHED AND BROKE LEAVING THE DISTAL PORTION OF THE CATHETER IN PATIENT UTERUS. CONSIDERING THAT THE REPORTED EVENTS OCCURRED DURING ESSURE INSERTION CAUSALITY WITH ESSURE THERAPY WAS CONSIDERED AS RELATED, EXCEPT FOR THE REPORTED HANDLING ERROR, WHICH WAS CONSIDERED, DUE TO ITS NATURE, AS UNRELATED TO THE SUSPECT INSERT. A PRODUCT TECHNICAL COMPLAINT (PTE) ANALYSIS WAS PERFORMED AND CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT. MEDICAL PTC ASSESSMENT CONSIDERED THAT,BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN UNITED STATES ON (B)(4) 2014 WHICH REFERS TO A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CATHETER DID NOT SEPARATE FROM THE DISTAL PORTION OF COIL AND COIL IN PLACE BUT CATHETER ALSO STILL IN PATIENT . NO INFORMATION GIVEN ON PATIENT'S HISTORY, PAST DRUGS, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATION. ON (B)(6) 2014, THE PT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR PERMANENT CONTRACEPTION. ESSURE LOT NUMBER WAS B94873. PHYSICIAN HAD DEPLOYMENT ISSUE WITH ESSURE CATHETER. THE CATHETER DID NOT SEPARATE FROM THE DISTAL PORTION OF COIL. COIL WAS IN PLACE BUT CATHETER ALSO STILL IN PT. BILATERAL PLACEMENT OCCURRED BUT CATHETER WAS STILL ATTACHED TO COIL ON ONE UNIT. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN CATHETER DID NOT SEPARATE FROM THE DISTAL PORTION OF COIL AND COIL IN PLACE BUT CATHETER ALSO STILL IN PT AND ESSURE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422521 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B94873

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR