BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1262861 · Received December 12, 2008

    Report

    Report Number
    2024168-2008-01378
    Event Type
    Injury
    Date Received
    December 12, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 13, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 2.75 X 23 MM PROMUS (PART 1009540-23B, LOT UNK), HAS BEEN FILED UNDER MFR# 2024128-2008-01205.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: FAILURE TO CROSS CAUSING DELAY IN PROCEDURE RESULTING IN BLOOD TRANSFUSION. DEVICE ISSUE: FAILURE TO CROSS. IT WAS REPORTED THAT THE PATIENT WAS PRESENTED ON A BALLOON PUMP; THEREFORE, THE DECISION WAS MADE NOT TO OPERATE ON THE PATIENT. PRE-DILATATION WAS PERFORMED WITH A POWERSAIL. THE 2.75 X 23 MM PROMUS STENT WAS DEPLOYED AT 20 ATM. POST-DILATATION WAS PERFORMED WITH THE PROMUS BALLOON AT 22 ATM AND A PERFORATION OCCURRED. AN ATTEMPT WAS MADE TO TREAT THE PERFORATION WITH A 3.5 X 16 MM JOMED GRAFTMASTER STENT, BUT WAS NOT SUCCESSFUL DUE TO CALCIFICATION. THE PHYSICIAN WAS HOPING THE PERFORATION WOULD SEAL ON ITS OWN. A BLOOD TRANSFUSION WAS REQUIRED. IT WAS LATER REPORTED THAT THE PATIENT IS NO LONGER ON THE BALLOON PUMP. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 407178

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention LOT UNK).| POWERSAIL| DILATATION CATHETER: MAVERICK| STENT: 2.75 X 23 MM PROMUS (PART 1009540-23B