BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1369384 · Received April 24, 2009

    Report

    Report Number
    2024168-2009-00703
    Event Type
    Death
    Date Received
    April 24, 2009
    Date of Event
    February 8, 2009
    Report Date
    April 2, 2009
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 2.5 X 23 PROMUS (LOT 8111761), HAS BEEN FILED UNDER MFR# 2021468-2009-00589. THE 3.5 X 28 PROMUS (LOT 8090541), INDICATED HAS BEEN FILED UNDER MFR # 2024168-2009-00590. THE 2.5 X 18 PROMUS (LOT 8111261), INDICATED HAS BEEN FILED UNDER 2024168-2009-00375. THE 2.5 X 28 PROMUS (LOT 8100961), INDICATED HAS BEEN FILED UNDER MFR# 2024168-2009-00591. THE 3.5 X 28 XIENCE (LOT 8073161), HAS BEEN FILED UNDER MFR# 2024168-2009-00592.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: THROMBOSIS, SUBSEQUENT DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. THIS IS BEING FILED BASED ON THE FINAL CEC ADJUDICATION RESULTS. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE LESIONS IN THE LAD AND RCA. A 2.5 X 23 MM PROMUS WAS IMPLANTED IN THE MID LAD. A 3.5 X 28 MM XIENCE WAS IMPLANTED IN THE PROXIMAL RCA. A 2.5 X 28 MM AND 3.5 X 28 MM PROMUS WERE IMPLANTED IN THE MID RCA. A 2.5 X 18 MM PROMUS AND ANOTHER COMPANY'S 2.5 X 18 MM STENT, WERE IMPLANTED IN THE DISTAL RCA. A SPIRAL DISSECTION OCCURRED IN THE MID TO DISTAL RCA, WITH NO REPORTED TREATMENT. AN ACUTE PERFORATION OCCURRED IN THE MID RCA, RESULTING IN A PERICARDIAL TAMPONADE, REQUIRING A PERICARDIOCENTESIS. THE PATIENT WAS HEMODYNAMICALLY COMPROMISED REQUIRING INTUBATION, IABP AND PRESSOR AGENTS. THE PERFORATION WAS SUCCESSFULLY TREATED WITH A 3.5 X 26 MM GRAFTMASTER STENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS IN CRITICAL CONDITION REQUIRING INTENSIVE CARE. THE PATIENT EXPIRED IN 2009. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| S 2.5X28 PROMUS| 2.5X18 PROMUS| STENT 2.5X8 ENDEAVOR| 3.5X28 XIENCE| 2.5X23 PROMUS| 3.5X28 PROMUS