BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1600541 · Received February 9, 2010

    Report

    Report Number
    2024168-2010-00220
    Event Type
    Injury
    Date Received
    February 9, 2010
    Date of Event
    September 1, 2009
    Report Date
    January 15, 2010
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE SECOND XIENCE V RX 3.5 X 12 MM (PART# 1009542-12/LOT# 7103161) MENTIONED IS BEING FILED UNDER THE SAME MFR NUMBER. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT EFFECTS OF ANGINA AND RESTENOSIS ARE LISTED IN THE PRODUCT RISK ASSESSMENT AND INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MFR, DESIGN OR LABELING.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-PERMANENT DAMAGE. REPORTING RATIONALE: RESTENOSIS UNTREATED. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2008, THE PT UNDERWENT STENTING OF THE PRE-DILATED DISTAL RIGHT CORONARY ARTERY (RCA) WITH A 2.5 X 18 MM PROMUS STENT. PRE-DILATATION WAS PERFORMED IN THE DISTAL CIRCUMFLEX (CX) WITH A 2.75 X 18 MM XIENCE V STENT, AND THE PROXIMAL CX WITH A 3.5 X 12 MM XIENCE V STENT. AT AN UNK TIME IN (B) (6) 2009, THE PT EXPERIENCED LEFT-SIDED DULL CHEST PAIN AT REST AND EXERTION. DIAGNOSTIC CORONARY ANGIOGRAPHY WAS PERFORMED WHICH REVEALED RESTENOSIS WITHIN BOTH THE PROXIMAL AND MID CIRCUMFLEX LESIONS TREATED AT THE INDEX PROCEDURE. THERE IS NO PLAN TO INTERVENE. AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED ON (B) (6) 2009; NO MYOCARDIAL INFARCTION. THE PT'S CONDITION IS CONTINUING. THERE IS NO ADD'L INFO 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 8062361

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability STENT: PROMUS 2.5 X 18 MM| LOT# 7103161)| XIENCE V RX 3.5 X 12 MM (PART# 1009542-12,