BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER POST-INFARCT VSD OCCLUDER

    MDR report key: 15403399 · Received September 12, 2022

    Report

    Report Number
    2135147-2022-01165
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 18, 2022
    Report Date
    November 24, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF DEVICE DEFORMITY COULD NOT BE CONFIRMED. THE INVESTIGATION CONFIRMED THAT THE DEVICE MET FUNCTIONAL SPECIFICATIONS WHEN ANALYZED UNDER NON-PHYSIOLOGICAL CONDITIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE LABELING DESIGN OR MANUFACTURING OF THE DEVICE. PER THE VSDMUSC PI FINAL INSPECTION PROCEDURE, THE RECOMMENDED SIZE DELIVERY SYSTEM FOR USE WITH A 24MM AMPLATZER VSD MUSCULAR PI IS A 10F.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A 24MM AMPLATZER POST-INFARCT MUSCULAR VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER WAS CHOSEN FOR IMPLANT. WHEN THE DEVICE WAS DEPLOYED, A MALFORMATION WAS NOTED. THE DEVICE WAS REMOVED AND RE-DEPLOYED OUTSIDE OF THE PATIENT, BUT THE DEVICE COULD NOT FORM ITS ORIGINAL SHAPE. THE DEVICE WAS REPLACED WITH ANOTHER 24MM AMPLATZER POST-INFARCT MUSCULAR VSD OCCLUDER. THE PATIENT STATUS WAS STABLE.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE DELIVERY SYSTEM USED TO DEPLOY THE 24MM AMPLATZER POST-INFARCT (PI) MUSCULAR VSD OCCLUDER (LOT 7986163) WAS A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (LOT 8041409). THE OCCLUDER FORMED ELONGATED SHAPE WHEN DEPLOYED IN PATIENT. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THERE WAS NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM. THE OCCLUDER WAS REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM THE DELIVERY CABLE. THE DEVICE WAS REPLACED WITH A 22MM AMPLATZER PI MUSCULAR VSD OCCLUDER (7973831), BUT THERE WAS A SIGNIFICANT RESIDUAL SHUNT, SO THE 22MM OCCLUDER WAS RECAPTURED AND REMOVED FROM THE PATIENT PRIOR TO RELEASE FROM DELIVERY CABLE. THERE WAS NO ALLEGATION AGAINST THE 22MM AMPLATZER PI MUSCULAR VSD OCCLUDER BESIDES BEING THE WRONG SIZE OF DEVICE FOR THE PATIENT. THE DEVICE WAS SUCCESSFULLY REPLACED WITH A 24MM AMPLATZER PI MUSCULAR VSD OCCLUDER (7986163). THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138321 AMPLATZER POST-INFARCT VSD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 7986163

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male