BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2051111 · Received April 5, 2011

    Report

    Report Number
    9612164-2011-00162
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    June 7, 2009
    Report Date
    March 10, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (MI). CONCLUSION: NO CONCLUSION CAN BE DRAWN (BASED ON THE INFORMATION PROVIDED NO ROOT CAUSE CAN BE DETERMINED).

    Description of Event or Problem · 1

    PATIENT UNDERWENT INDEX PROCEDURE WITH PRE-TREATMENT BALLOON ANGIOPLASTY AND DELIVERY OF AN ENDEAVOR RESOLUTE RX DRUG ELUTING STENT IN THE MID RCA. REPEAT ANGIOGRAPHY 2 WEEKS LATER FOR A STAGED PROCEDURE IN THE ABSENCE OF RECURRENT CLINICAL SYMPTOMS OR A FUNCTIONAL ISCHEMIA STUDY REVEALED A SITE REPORTED 0% RESTENOSIS OF THE TARGET LESION. THE ANGIOGRAPHIC CORE LAB REPORTED A 22% IN-LESION RESTENOSIS OF THE TARGET LESION. THE CATHETERIZATION REPORT NOTED AN 80% STENOSIS OF THE DISTAL CX. THE PATIENT UNDERWENT REPEAT REVASCULARIZATION WITH PLACEMENT OF AN ENDEAVOR SPRINT RX DRUG ELUTING STENT IN THE DISTAL CX. THE SITE REPORTED, THE PATIENT WAS REHOSPITALIZED APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE FOR AN MI. REPEAT ANGIOGRAPHY FOR RECURRENT CLINICAL SYMPTOMS AND A POSITIVE FUNCTIONAL ISCHEMIA STUDY REVEALED A 90% STENOSIS OF THE DISTAL RCA AS NOTED IN THE CATHETERIZATION REPORT. THE ANGIOGRAPHIC CORE LAB REPORTED A 27% IN-LESION RESTENOSIS OF THE MID RCA TARGET LESION. THE PATIENT UNDERWENT REPEAT REVASCULARIZATION WITH PLACEMENT OF A NON-MEDTRONIC STENT IN THE DISTAL RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization CLOPIDOGREL| PRIOR TO EVENT| ASA