BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1368804 · Received April 23, 2009

    Report

    Report Number
    2024168-2009-00693
    Event Type
    Injury
    Date Received
    April 23, 2009
    Date of Event
    January 15, 2009
    Report Date
    April 1, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS BEING FILED UNDER THE SAME MFR NUMBER. RESULTS AND CONCLUSION SUMMATION- PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. ANGINA AND RESTENOSIS ARE LISTED IN THE XIENCE V IFU AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUAL ISSUE. THERE WAS NO REPORT OF ANY PRODUCT MALFUNCTIONS IDENTIFIED DURING DEPLOYMENT OF THE STENTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED PT EFFECTS. IT IS LIKELY THAT THE ANGINA WAS A SECONDARY EFFECT OF THE RESTENOSIS. HOWEVER, A DEFINITIVE CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT THE INDEX PROCEDURE WAS PERFORMED IN 2008 - PREDILATATION WAS PERFORMED PRIOR TO STENTING. THE PROCEDURE WAS TO TREAT INSTENT RESTENOSIS OF PREVIOUSLY PLACED METALIC STENTS (UNK TYPE) IN THE PROXIMAL AND DISTAL CX. A XIENCE V (2ND) (1009540-28 / 80442242) WAS PLACED IN THE PROXIMAL CX AND A XIENCE V (1ST) 1009539-28 / 8041842) WAS PLACED IN THE DISTAL CX. IN 2009, THE PT EXPERIENCED RECURRENT CHEST PAIN AND REPORTED RECURRENT "CHEST SORENESS" AT THE FOLLOW UP VISIT. AN OUT-PATIENT HEART CATH WAS SCHEDULED. INSTENT RESTENOSIS OF THE PREVIOUSLY STENTED TARGET VESSEL (XIENCE) WAS NOTED AND PTCA WAS PERFORMED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8042242

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention STENT: XIENCE V EVEROLIMUS ELUTING CORONARY STENT| SYSTEM (PART# 1009539-28 LOT# 8041842)