BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1760649 · Received July 14, 2010

    Report

    Report Number
    2024168-2010-01395
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    May 10, 2010
    Report Date
    June 19, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE STENT REMAINS IN THE PT. A F/U WILL BE SUBMITTED WITH ALL RELEVANT INFO. THE ALLSTAR (PART UNK, LOT UNK), INDICATED, IS BEING FILED UNDER A SEPARATE MFR #.

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT ON 7/29/2010, REVEALED THAT THE REPORTED MYOCARDIAL INFARCTION WAS DETERMINED TO BE DUE TO THE NON-TARGET OBTUSE MARGINAL ARTERY AND THE THREE INDEX XIENCE V STENTS WERE PATENT PER THE ANGIOGRAM IN (B)(6) 2010. THEREFORE, THIS COMPLAINT SHOULD NOT HAVE BEEN FILED AGAINST THIS INDEX. XIENCE V STENT; HOWEVER, SINCE A MEDICAL DEVICE REPORT (MDR) HAS ALREADY BEEN FILED, THIS EVENT MUST REMAIN A COMPLAINT AND MDR REPORTABLE.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: MI REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6)2007, THE PT UNDERWENT STENTING IN THE PREDILATED MID RIGHT CORONARY ARTERY (RCA) WITH TWO XIENCE V STENTS AND IN THE PREDILATED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH ONE XIENCE V STENT. THE SECOND RCA XIENCE V STENT WAS IMPLANTED FOR TREATMENT OF A DISSECTION DISTAL TO THE TARGET LESION THAT WAS IDENTIFIED AFTER POST DILATATION, CAUSED BY AN ALLSTAR GUIDEWIRE. ON (B) (6)2010, THE PT BEGAN EXPERIENCING ANGINA, WAS ADMITTED TO THE HOSPITAL ON (B) (6)2010, AND DIAGNOSED WITH A NON Q-WAVE MYOCARDIAL INFARCTION. THE PT UNDERWENT DIAGNOSTIC CORONARY ANGIOGRAPHY WHICH REVEALED TOTAL OCCLUSION OF THE OBTUSE MARGINAL DUE TO THROMBUS, AND A 90% LESION IN THE MID RCA GREATER THAN 5 MM FROM THE INDEX STENT. REVASCULARIZATION WAS PERFORMED ON (B) (6)2010, VIA BALLOON ANGIOPLASTY AND IMPLANTATION OF A BARE METAL STENT IN THE MID RCA. THE PT'S CONDITION RESOLVED WITHOUT SEQUELA ON (B) (6)2010. THERE WAS NO ADD'L INFO PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, ADDITIONAL INFORMATION INDICATED THAT AN ANGIOGRAM DONE IN (B)(6) 2010, FOUND THAT THE THREE INDEX XIENCE STENTS WERE PATENT.

    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 60601P1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| S| R GUIDE WIRE: ALLSTAR (PART UNK, LOT)| STENT: XIENCE V (X2)| GUIDE WIRE: ALLSTAR (PART UNK, LOT)| STENT: XIENCE V (X2)