BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1784634 · Received July 30, 2010

    Report

    Report Number
    2024168-2010-01528
    Event Type
    Injury
    Date Received
    July 30, 2010
    Date of Event
    April 13, 2009
    Report Date
    July 7, 2010
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED. THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM, PART# 1009541-23B, LOT# 8052841, SERIAL# (B)(4) INDICATED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: REQUIRED SURGICAL INTERVENTION. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE A PROMUS 3.0 X 23 STENT WAS DEPLOYED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) LESION AND A PROMUS 3.5 X 18 STENT WAS DEPLOYED IN THE MID LAD LESION. A PERFORATION WAS NOTED IN THE DISTAL LAD AFTER THE PROMUS 3.0 X 23 STENT WAS DEPLOYED. THE PERFORATION WAS TREATED WITH A GRAFTMASTER 3.0 X 12, WHICH REPORTEDLY SEALED; HOWEVER, THE PATIENT WAS TAKEN FOR CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY ANYWAY. THE PATIENT DID HAVE A SMALL AMOUNT OF PERICARDIAL EFFUSION. THE SURGERY WAS SUCCESSFUL AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. 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 523541

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R