BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1140233 · Received August 29, 2008

    Report

    Report Number
    2024168-2008-00742
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MULTI LINK RX VISION WAS FILED UNDER MFR# 2024168-2008-00728. THE 4.0 X 16 GRAFTMASTER IS BEING FILED UNDER A DIFFERENT MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: FAILURE TO CROSS WITH THE GRAFTMASTER; REMAINS IN PT AT UNINTENDED SITE/REQUIRED SECOND DEVICE. DEVICE ISSUE: FAILURE TO CROSS. IT WAS REPORTED THAT A VISION STENT WAS IMPLANTED AND A PERFORATION WAS OBSERVED IN THE RIGHT CORONARY ARTERY (RCA). A JOSTENT GRAFTMASTER 4.0 X 16 MM WAS USED AS TREATMENT; HOWEVER, IT WOULD NOT CROSS AND WAS REMOVED. ANOTHER GRAFTMASTER 3.0 X 16 WAS USED AND AN ATTEMPT WAS MADE TO INSERT IT BUT IT WAS UNABLE TO CROSS AS WELL AND WAS IMPLANTED PROXIMAL TO THE PERFORATION SITE, AT AN UNINTENDED SITE. A MAVERICK BALLOON CATHETER WAS THEN USED TO SEAL THE PERFORATION. PROTAMINE WAS ALSO ADMINISTERED TO THE PATIENT. 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 440262

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention| S LOT# 342987)| STENT: MULTI-LINK RX VISION (PART# 1007849-28| JOSTENT GRAFTMASTER 4.0 X 16 (PART# 12746-16| LOT# 8050231)