BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1805011 · Received August 13, 2010

    Report

    Report Number
    2024168-2010-01674
    Event Type
    Injury
    Date Received
    August 13, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 20, 2010
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROMUS 3.5 X 23 MM (PART# 1009542-23B, LOT# 9121441) IS BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    DEVICE ISSUE: FAILURE TO CROSS. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: REQUIRING MEDICAL INTERVENTION WITH SECOND GRAFTMASTER/REQUIRED MEDICAL INTERVENTION. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT THE PERFORATION OCCURRED DURING POST DILATATION OF A PROMUS 3.5 X 23 STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PERFORATION REQUIRED TREATMENT WITH A GRAFTMASTER STENT. HOWEVER, THE FIRST GRAFTMASTER 3.5 X 26 DID NOT CROSS TO TREAT THE PERFORATION. A SECOND GRAFTMASTER 3.5 X 16 WAS USED AND DID SUCCESSFULLY CROSS AND TREAT THE PERFORATION. THERE WERE NO FURTHER PATIENT EFFECTS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 579768

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention PROMUS 3.5 X 23 (PART# 1009542-23B, LOT# 9121441)