BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1172583 · Received September 19, 2008

    Report

    Report Number
    2953200-2008-00833
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    April 3, 2012
    Report Date
    April 10, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS - SEVERE CALCIFICATION. CONCLUSIONS - SEVERE CALCIFICATION. (DELIVERY SYSTEM).

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 18 MM LENGTH ENDEAVOR RESOLUTE RX DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF AN M1 LESION. LESION MORPHOLOGY WAS REPORTED AS EXTREME CALCIFICATION IN THE LAD, LMT AND LCX. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE UNDEPLOYED STENT DISLODGED FROM THE DELIVERY BALLOON IN THE LMT/LCX. THE UNDEPLOYED STENT WAS CRUSHED INTO THE LMT. A SECOND ENDEAVOR RESOLUTE DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED IN THE LAD. THE PATIENT IS FINE. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Description of Event or Problem · 1

    APPROXIMATELY 3 YEARS AND 8 MONTHS POST THE INDEX PROCEDURE, IT IS REPORTED THAT THE PATIENT HAD CORONARY ARTERY RESTENOSIS WHICH REQUIRED HOSPITALIZATION AND REQUIRED REVASCULARIZATION TO THE PROXIMAL LCX AND 1ST OM. TWO OTHER BRAND STENTS WERE IMPLANTED. THE PATIENT IS REPORTED TO HAVE RECOVERED WITH TREATMENT. INVESTIGATOR HAS INDICATED THAT EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000627397

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention