BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ BALLOON-EXPANDABLE STENT

    MDR report key: 60923 · Received December 30, 1996

    Report

    Report Number
    2247023-1996-00155
    Event Type
    Injury
    Date Received
    December 30, 1996
    Date of Event
    November 15, 1996
    Report Date
    December 2, 1996
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PLACEMENT OF A STENT WAS PERFORMED TO TREAT A SEVERE FOCAL OBSTRUCTION IN A LARGE DIAMETER SAPHENOUS VEIN BYPASS GRAFT SUPPLYING TWO CIRCUMFLEX MARGINAL BRANCH. A CO'S 104 STENT (LOT #113380) WAS USED BECAUSE OF THE LARGE CALIBER OF THE VEIN GRAFT. THIS STENT WAS MOUNTED ON A 5MM DIAMETER, 2CM LONG MEDITECH SYMMETRY BALLOON. THE STENT WAS DELIVERED AND EXPANDED BY BALLOON INFLATION WITHOUT MECHANICAL COMPLICATIONS. AFTER PLACEMENT OF THIS STENT, THE PT DEVELPED MYOCARDIAL ISCHEMIA AND AN OBSTRUCTION IN THE VEIN GRAFT WAS NOTED JUST PROXIMAL TO THE STENT. THE SAME BALLOON CATHETER WAS PREPARED FOR REUSE AND A SECOND STENT OF THE SAME TYPE WAS SECURED TO THE BALLOON AND DELIVERED TO THE OBSTRUCTION. THE BALLOON WAS INFLATED TO EXPAND THE STENT, BUT THE BALLOON RUPTURED BEFORE STENT EXPANSION OCCURRED. THE BALLOON BECAME ENTRAPPED IN THE STENT SO THAT IT COULD NOT BE WITHDRAWN FROM THE STENT. WITHDRAWAL OF THE BALLOON CATHETER RESULTED IN MOVEMEMENT OF THE STENT AND BALLOON TO THE PROXIMAL PORTION OF THE VEIN GRAFT. THIS WAS ACCOMPANIED BY MYOCARDIAL ISCHEMIA PRESUMABLY RELATED TO EMBOLIZATION OF MATERIAL FROM THE VEIN GRAFT INTIMA THAT WAS DISLODGED BY STENT WITHDRAWAL. THIS STENT BECAME ENTRAPPED AT THE OSTIUM OF THE VEIN GRAFT OSTIUM WITH 4MM FROM ANOTHER CO'S BALLOON, A 4.5MM FROM A THIRD CO'S BALLOON, AND A 6MM FROM A THIRD CO'S BALLOON. THE STENT WAS SUCCESSFULLY EXPANDED, BUT THE BALLOON RUPTURED DURING EACH INFLATION. AT THE CONCLUSION OF THE PROCEDURE THE TARGET VEIN GRAFT STENOSIS WAS SUCCESSFULLY TREATED BY PLACEMENT OF THE FIRST STENT. THE VEIN GRAFT WAS PATENT AND NORMAL ANGIOGRAPHIC FLOW WAS PRESENT. THE PT SUSTAINED A MYOCARDIAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ BALLOON-EXPANDABLE STENT Implant STENT ALONE MAF NEW JERSEY PLANT NA 113380

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening