BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1764533 · Received July 16, 2010

    Report

    Report Number
    2024168-2010-01417
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 23, 2010
    Manufacturer
    ABBOTT VASCULAR GERMANY
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE XIENCE V 3.5 X 28 MM (PART#1009542-28/LOT#0020141/(B)(4)) AND THE JOSTENT GRAFTMASTER 4.0 X 12 MM (PART#12746-12/LOT#579477) ARE BEING FILED UNDER SEPARATE MANUFACTURER NUMBERS. THE STENT REMAINS IN THE PATIENT. A SPECIFIC CAUSE FOR THE REPORTED EVENT AND THE RELATIONSHIP TO THE DEVICE COULD NOT BE DETERMINED, HOWEVER, THERE WAS NO REPORTED PRODUCT DEFICIENCY. TOTAL OCCLUSION OF THE CORONARY ARTERY IS A KNOWN ADVERSE PATIENT EVENT AS LISTED IN THE GRAFTMASTER OTW INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    ADVERSE EVENT: PERFORATION REQUIRING MEDICAL INTERVENTION. ONSET OF ADVERSE EVENTS: DURING THE PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED THAT A CORONARY ARTERY PERFORATION OCCURRED AFTER POST DILATATION OF THE XIENCE V STENT (3.5 X 28) DEPLOYED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) WHICH EXTENDED BACK INTO THE LEFT MAIN. THE PERFORATION REQUIRED TREATMENT WITH TWO GRAFTMASTER STENTS (4.0 X 12 AND 3.5 X 12). THE GRAFTMASTER STENTS WERE DEPLOYED AND SEALED THE PERFORATION. THERE WAS AN OCCLUSION OF THE LEFT CIRCUMFLEX ARTERY AFTER THE TWO GRAFTMASTER STENTS WERE DEPLOYED AND THE OCCLUSION OF THE LEFT CIRCUMFLEX ARTERY WAS LEFT UNTREATED. THE PATIENT UNDERWENT PERICARDIOCENTESIS, PRESSORS, PERFUSION FOR THE BLEEDING AND INTRA-AORTIC BALLOON PUMP (IABP) PLACEMENT FOR HEMODYNAMIC SUPPORT; ECHO WAS DONE IMMEDIATELY AFTER THE PERFORATION AND SHOWED SMALL PERICARDIAL EFFUSION WITH AND EJECTION FRACTION (EF) OF 45%. ANOTHER ECHO WAS DONE TWO HOURS AFTER WITH NO SIGNIFICANT CHANGE. ANOTHER ECHO WAS DONE ON (B)(6) 2010 AND SHOWED PERICARDIAL EFFUSION SIZE DECREASED WITH EF OF 35%. THE PATIENT WAS SUCCESSFULLY WEANED OF THE IABP ON (B)(6) 2010 AND AT PRESENT IS HEMODYNAMICALLY STABLE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR GERMANY NA 584326

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R (B)(4)| JOSTENT GRAFTMASTER 4.0 X 12 MM, PART# 12746-12| LOT# 579477| XIENCE V 3.5 X 28 MM, PART# 1009542-28/LOT0020141