BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1678633 · Received May 7, 2010

    Report

    Report Number
    2024168-2010-00933
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 12, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE 2.5 X 18 MM XIENCE V (PART 1009539-18, LOT 9082061), IS BEING FILED UNDER THE SAME MFR#. EVALUATION SUMMARY: THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. IT WAS REPORTED THAT DIRECT STENTING WAS PERFORMED. THE XIENCE V IFU STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. IT WAS ALSO REPORTED THAT A NON-ABBOTT DRUG ELUTING STENT WAS PREVIOUSLY IMPLANTED. THE IFU CAUTIONS: EFFECTS OF MULTIPLE STENTING USING XIENCE V STENTS COMBINED WITH OTHER DRUG-ELUTING STENTS ARE ALSO UNKNOWN. WHEN MULTIPLE DRUG-ELUTING STENTS ARE REQUIRED, USE ONLY XIENCE V STENTS IN ORDER TO AVOID POTENTIAL INTERACTIONS WITH OTHER DRUG-ELUTING OR COATED STENTS. IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION(S) CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: RESTENOSIS REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6) 2006, THE PATIENT UNDERWENT STENTING IN THE RAMUS ARTERY WITH A NON-ABBOTT STENT. ON (B) (6) 2009, THE PATIENT UNDERWENT DIRECT STENTING IN THE RAMUS ARTERY IN DE NOVO LESION WITH THE 2.5 X 12 MM XIENCE V STENT, DIRECT STENTING IN THE RAMUS ARTERY IN RESTENOSIS LESION ((B) (6) 2006) WITH THE 2.5 X 18MM XIENCE, DIRECT STENTING IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 2.5 X 28MM XIENCE V STENT, AND DIRECT STENTING IN DISTAL LAD WITH A 2.5 X 28MM XIENCE V STENT. THE PREVIOUSLY PLACED NON-ABBOTT STENT WAS BETWEEN THE TWO INDEX XIENCE STENTS IN THE RAMUS ARTERY. THE THREE STENTS IN THE RAMUS ARTERY ARE OVERLAPPING. ON (B) (6) 2010, THE PATIENT EXPERIENCED UNSTABLE ANGINA THAT REQUIRED REVASCULARIZATION VIA PERCUTANEOUS CORONARY INTERVENTION ON (B) (6) 2010, FOR IN-STENT RESTENOSIS OF THE XIENCE STENT IN THE DISTAL RAMUS AND THE PROXIMAL PART OF THE NON-ABBOTT STENT. THE PATIENT WAS DISCHARGED THE SAME DAY ON (B) (6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 9082661

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R 2.5 X 28 MM XIENCE V (X2)| STENT: 2.5X18MM XIENCE V (PART 1009539-18,| LOT# 9082061)