BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 8861945 · Received August 5, 2019

    Report

    Report Number
    2135147-2019-00236
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    May 28, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    MLV
    UDI-DI
    00811806010144
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF DEVICE DEFORMATION COULD NOT BE CONFIRMED. THE INVESTIGATION CONFIRMED THE DEVICE MET VISUAL AND FUNCTIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, PER THE SITE THE DEVICE RETURNED TO NORMAL FORM IN VITRO AND DEFORMED ONCE DEPLOYED IN THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 17MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. HOWEVER, THE LEFT DISC DEPLOYED WITH A "COBRA" SHAPED DEFORMATION AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE DEVICE WAS WASHED WITH PHYSIOLOGIC SERUM AND HEATED 3 TIMES WITH THE DEVICE RETURNING TO NORMAL FORM IN VITRO. HOWEVER, AFTER 3 UNSUCCESSFUL ATTEMPTS TO DEPLOY THE DEVICE IN THE PATIENT AS THE DEVICE CONTINUED TO DEPLOY IN A "COBRA" SHAPE, A SECOND 17MM AMPLATZER SEPTAL OCCLUDER (LOT #: UNKNOWN) WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 17MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. HOWEVER, THE LEFT DISC DEPLOYED WITH A "COBRA" SHAPED DEFORMATION AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE DEVICE WAS WASHED WITH PHYSIOLOGIC SERUM AND HEATED 3 TIMES WITH THE DEVICE RETURNING TO NORMAL FORM IN VITRO. HOWEVER, AFTER 3 UNSUCCESSFUL ATTEMPTS TO DEPLOY THE DEVICE IN THE PATIENT AS THE DEVICE CONTINUED TO DEPLOY IN A "COBRA" SHAPE, A SECOND 17MM AMPLATZER SEPTAL OCCLUDER (LOT #: UNKNOWN) WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655396 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ST. JUDE MEDICAL CATD 9-ASD-017 6607525 00811806010144

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention