BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1142746 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00733
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 28, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: PERFORATION NOT SEALED REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: LEAK - STENT GRAFT. IT WAS REPORTED THAT A PERFORATION WAS CAUSED BY ANOTHER COMPANY'S BALLOON, DURING POSTDILATATION OF A HEAVILY CALCIFIED LESION IN THE LAD. THE PERFORATION WAS BEING TREATED WITH THE GRAFTMASTER DEVICES. THE FIRST GRAFTMASTER ALMOST COMPLETELY SEALED THE PERFORATION, AND WOULD HAVE SEALED IT COMPLETELY; HOWEVER, THE PHYSICIAN DID NOT WANT TO WAIT AND CHOSE ANOTHER GRAFTMASTER TO FINISH SEALING THE PERFORATION. THE SECOND GRAFTMASTER DISLODGED FROM THE BALLOON INTO THE CORONARY ARTERY. AS NO SURGERY BACKUP WAS AVAILABLE AT THIS ACCOUNT, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE THE PHYSICIAN WENT IN WITH A GUIDE WIRE AND ANOTHER BALLOON AND WAS ABLE TO DEPLOY THE GRAFTMASTER STENT AT THE PERFORATION, SUCCESSFULLY SEALING THE PERFORATION. 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 418345

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention DIL CATH: QUANTUM MAVERICK