BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDITECH SYMMETRY BALLOON

    MDR report key: 60125 · Received December 30, 1996

    Report

    Report Number
    60125
    Event Type
    Injury
    Date Received
    December 30, 1996
    Date of Event
    November 15, 1996
    Report Date
    December 2, 1996
    Manufacturer
    MEDITECH
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility 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 TOW CIRCUMFLEX MARGINAL BRANCH. A STENT (LOT #113380) WAS USED BECAUSE OF THE LARGE CALIBER OF THE VEIN GRAFT. THIS STENT WAS MOUNTED ON A 5MM DIAMETER, 2 CM LONG MEDITECH SYMMETRY BALLOON. THE STENT WAS DELIVERED AND EXPANDED BY BALLOON INFLATION WITHOUT MECHANICAL COMPLICATIONS,. AFTER PLACEMENT OF THIS STENT, THE PT DEVELOPED 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 AND 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 THE BALLOON BECAME ENTRAPPED IN THE STENT SO THAT IT COULD NOT BE WITHDRAWN FROM THE STENT.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 MOVEMENT 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 A 4MM SCIMED NC BANDIT BALLOON, A 4.5MM, AND A 6MM 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 SUCCESSFULY 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 MEDITECH SYMMETRY BALLOON * LIT MEDITECH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening