BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4192046 · Received October 22, 2014

    Report

    Report Number
    2951250-2014-00447
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 12, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    UPON INTERNAL REVIEW IT WAS NOTED THAT THE FOLLOWING INFORMATION WAS INCORRECTLY SUBMITTED TO 2951250-2015-00447. FOLLOW UP INFORMATION RECEIVED ON 02-APR-2015: FOLLOW-UP ATTEMPTS WERE DONE, WITH NO RESPONSE TO DATE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND THE HCP PERFORATED THE TUBE, FOUND BOTH COILS SITTING IN THE PELVIC. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE AND IT IS LISTED ON THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS PARTICULAR CASE THE HEALTH CARE PROFESSIONAL (HCP) PERFORATED THE TUBE DURING INSERTION, SHE PERFORMED A LAPAROSCOPY AND FOUND BOTH COILS IN THE PELVIS. THE HCP DID A REGULAR TUBAL AND REMOVED BOTH COILS. THEREFORE, GIVEN THE NATURE OF THE REPORTED EVENT, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT DUE TO THE REQUIRED INTERVENTION (LAPAROSCOPY).A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN UNITED STATES ON 26-SEP-2014 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2014 FOR STERILIZATION. PHYSICIAN REPORTED THAT HE PERFORATED THE TUBE. HE OPENED UP THE PATIENT LAPAROSCOPICALLY AND FOUND BOTH COILS SITTING IN THE PELVIC. THE HEALTH CARE PROFESSIONAL DID A REGULAR TUBAL AND REMOVED BOTH COILS. FOLLOW UP INFORMATION FROM 26-SEP-2014: NO NEW CLINICAL INFORMATION PROVIDED. PTC INVESTIGATION RESULT WAS RECEIVED ON 07-OCT-2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). (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. 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. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFECT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. THE AE CASE REFERS ALSO TO A USABILITY ISSUE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. THE REPORTED USABILITY ISSUE WILL BE SUBJECT TO POST MARKET SURVEILLANCE MONITORING. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND THE HCP PERFORATED THE TUBE, FOUND BOTH COILS SITTING IN THE PELVIC. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL SIGNIFICANCE AND IT IS LISTED ON THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS PARTICULAR CASE THE HEALTH CARE PROFESSIONAL (HCP) PERFORATED THE TUBE DURING INSERTION, SHE PERFORMED A LAPAROSCOPY AND FOUND BOTH COILS IN THE PELVIS. THE HCP DID A REGULAR TUBAL AND REMOVED BOTH COILS. THEREFORE, GIVEN THE NATURE OF THE REPORTED EVENT, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT DUE TO THE REQUIRED INTERVENTION (LAPAROSCOPY). A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT (NO VALID LOT NUMBER). FOLLOW UP INFORMATION (UTERINE PERFORATION QUESTIONNAIRE) HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671119 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention