BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1937223 · Received December 23, 2010

    Report

    Report Number
    2024168-2010-02941
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    October 1, 2010
    Report Date
    December 7, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, ISCHEMIA 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 OR DESIGN. IT WAS REPORTED THE LESION WAS NOT PRE-DILATED PRIOR TO IMPLANTING THE XIENCE V STENT. IT SHOULD BE NOTED THE IFU STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. IT DOES NOT APPEAR THAT THE REPORTED FAILURE TO PRE-DILATE THE LESION WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT; HOWEVER, THIS CANNOT BE DEFINITIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. NO PRE-DILATATION PRIOR TO STENTING. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT MONITORING WAS CHECKED IN ERROR ON FOLLOW-UP NUMBER 1. THERE WAS NO REMEDIAL ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE ABSOLUTE PRO STENT DELIVERY SYSTEM (PART #1011924-060, LOT #9092851) WAS REMOVED FROM THE PACKAGING, THE HANDLE WAS IN THE LOCKED POSITION AND THE TIP OF THE STENT WAS PARTIALLY EXPOSED FROM THE SHEATH. A SECOND ABSOLUTE PRO (PART #1011924-060, LOT #0052751) WAS REMOVED FROM THE PACKAGING AND WAS FOUND LOCKED WITH THE STENT PARTIALLY DEPLOYED. THE DEVICES WERE NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NON-ABBOTT DEVICE WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT STENTING IN THE DISTAL RIGHT CORONARY ARTERY AND THE PROXIMAL FIRST RIGHT POSTEROLATERAL ARTERY WITH ONE 3.0 X 28 XIENCE V STENT. IN (B)(6) 2010, THE PATIENT EXPERIENCED ANGINA AND ON (B)(6) 2010, A CARDIAC CATHETERIZATION REVEALED IN-STENT RESTENOSIS AND A NEW LESION. ON (B)(6) 2010, THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 7121362

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R| S