BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 1342839 · Received March 13, 2009

    Report

    Report Number
    2135147-2009-00030
    Event Type
    Injury
    Date Received
    March 13, 2009
    Date of Event
    July 24, 2007
    Report Date
    March 13, 2009
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE THE FOLLOWING MFR. REPORTS FOR THE FOLLOWING DEVICES: 2135147-2009-00030: 9-PFO-025; 2135147-2009-00031: 9-ASD-022; 2135147-2009-00032: 9-ASD-020; 2135147-2009-00033: 9-ASD-MF-25; 2135147-2009-00034: 9-ASD-MF-25; 2135147-2009-00035: 9-PFO-025. THE AMPLATZER PFO OCCLUDER HAD HDE APPROVAL AT THE TIME OF IMPLANT. AGA MEDICAL WITHDREW THE HDE IN 2006.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM AN ARTICLE TITLED, "NICKEL ALLERGY IN INTERATRIAL SHUNT DEVICE-BASED CLOSURE PATIENTS". A TOTAL CONSECUTIVE PATIENTS WERE ENROLLED OVER A TWELVE-MONTH PERIOD REFERRED TO THE HOSPITAL FOR CATHETER-BASED CLOSURE OF INTERATRIAL SHUNTS. PATIENTS WERE INVESTIGATED FOR PREVIOUS HYPERSENSITIVITY TO NICKEL AND WERE REQUIRED TO TEST POTENTIAL NICKEL ALLERGY WITH CUTANEOUS PATCH TEST (TRUE TEST) BEFORE DEVICE IMPLANTATION. ROUTINELY, CLINICAL VISIT WITH LABORATORY EXAMINATIONS, AND TTE WERE SCHEDULED AT 1, 6, AND 12 MONTHS. SOME PATIENTS HAD PROVED SYMPTOMATIC AND INSTRUMENTAL NICKEL ALLERGY AS SHOWED BY CUTANEOUS PATCH SKIN TEST AND DESPITE THEIR ALLERGY PREFERRED TO UNDERGO TO THE DEVICE-BASED CLOSURE. BETWEEN THE 2ND AND 3RD POSTOPERATIVE DAY, 8 OUT OF 9 PATIENTS DEVELOPED A SORT OF "DEVICE SYNDROME" THAT INCLUDED CONCURRENT CHEST DISCOMFORT, EXERTIONAL DYSPNEA AND ASTHENIA, AND MILD LEUKOCYTOSIS. THE SYNDROME WAS TREATED WITH PREDNISONE AND CLOPIDOGREL AND IN ALL WAS RESOLVED AFTER 1-WEEK THERAPY. INTERESTINGLY, NONE OF THE PATIENTS WITHOUT NICKEL ALLERGY DEVELOPED POST-CLOSURE SYMPTOMS (P < .001). OF PATIENTS THAT DEVELOPED A SORT OF 'DEVICE SYNDROME'; SOME WERE AMPLATZER OCCLUDERS (TWO SEPTAL, TWO PFO AND TWO CRIBRIFORM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER PFO OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-PFO-025

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other