BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 9498465 · Received December 19, 2019

    Report

    Report Number
    2135147-2019-00427
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    November 27, 2019
    Report Date
    January 22, 2020
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A DEFORMED DEPLOYMENT WAS CONFIRMED. FOLLOWING THE SIMULATED DEPLOYMENT, THE BULBOUS SHAPE RETURNED TO NORMAL AND MET 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 DEFINED MANUFACTURING SPECIFICATIONS AT THE TIME OF RELEASE TO COMMERCIALIZATION. THOUGH THE OCCLUDER WAS DETERMINED TO MEET FUNCTIONAL SPECIFICATIONS, THE ROOT CAUSE OF DEFORMATION UPON INITIAL DEPLOYMENT HAS BEEN INVESTIGATED AND A RESOLUTION PLAN AIMED AT ADDRESSING ENHANCED LOADING TECHNIQUES AS WELL AS IMPROVED IN-PROCESS INSPECTION THAT BETTER REPRESENTS HOW A DEVICE IS LOADED AND DEPLOYED DURING CLINICAL USE ARE BEING IMPLEMENTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2019 DR. (B)(6) HAD A PFO DEVICE WHICH DID NOT DEPLOY PROPERLY. PHYSICIAN WAS NOT HAPPY WITH THE SHAPE OF THE DEVICE (MODEL # 9-PFO-030, LOT 7032114). A NEW DEVICE WAS IMPLANTED BUT THE LOT # AND MODEL # IS CURRENTLY UNKNOWN. THE LOT # AND MODEL # OF THE IMPLANTED DEVICE WAS REQUESTED FROM THE CUSTOMER ON (B)(6) 2019 UPON BEING NOTIFIED OF THE DEFECTIVE DEVICE. THE PATIENT IS IN STABLE CONDITION.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 30MM AMPLATZER PFO OCCLUDER WAS SELECTED FOR IMPLANT. HOWEVER, THE DEVICE DID NOT DEPLOY PROPERLY WHILE INSIDE THE PATIENT AND THE PHYSICIAN WAS NOT HAPPY WITH THE SHAPE OF THE DEVICE. A NEW UNKNOWN SIZED UNKNOWN DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289271 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ST. JUDE MEDICAL CATD 9-PFO-030 7032114

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention