BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1078336 · Received July 17, 2008

    Report

    Report Number
    2024168-2008-00579
    Event Type
    Injury
    Date Received
    July 17, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION: THE DEVICE WAS IN WORKING ORDER AND LEFT ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND GMBH IN RANGENDINGEN AS PER SPECS. IT IS REPORTED THAT THE STENT WAS USED TO TREAT A PERFORATION WHICH OCCURRED DURING THE INFLATION OF ANOTHER COMPANY'S 4.0 MM BALLOON. HOWEVER, THE STENT WAS NOT IMPLANTED AND THE PERFORATION WAS NOT SEALED AS THE STENT GRAFT COULD NOT CROSS THE LESION TO REACH PERFORATION. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, A ROOT CAUSE CAN NOT BE IDENTIFIED. NO PT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: REQUIRED A SECOND DEVICE FOR TREATMENT. DEVICE ISSUE: FAILURE TO CROSS. IT WAS REPORTED THAT DURING THE PTCA PROCEDURE A PERFORATION OCCURRED WHILE INFLATING ANOTHER COMPANY'S 4.0 BALLOON. AN ATTEMPT WAS MADE TO TREAT THE PERFORATION WITH THE GRAFTMASTER, BUT IT WOULD NOT CROSS. ANOTHER 4.0 BALLOON WAS ADVANCED AND PERFORMED SEVERAL LONG INFLATIONS, WHICH SEALED THE PERFORATION. THIS TOOK APPROX 20-30 MINS. THE LESION WAS THEN STENTED TO COMPLETE THE PROCEDURE. THE PT OUTCOME WAS GOOD. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 505763

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DILATATION CATHETER 4.0 MAVERICK