BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1930766 · Received December 16, 2010

    Report

    Report Number
    2024168-2010-02787
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    February 14, 2010
    Report Date
    November 24, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) NO PRE-DILATATION. VESSEL CLOSURE: PERCLOSE 3.0X23 XIENCE V STENT (B)(4) LOT 8042161. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS 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 THE XIENCE V WAS DIRECT STENTED IN THE LESION. IT SHOULD BE NOTED THE IFU STATES TO PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT STENTING IN THE PREDILATED OBTUSE MARGINAL ARTERY WITH A 3.0 X 23 XIENCE V STENT AND DIRECT STENTING IN THE FIRST DIAGONAL ARTERY WITH A 2.5 X 12 XIENCE V STENT. ON (B)(6) 2010, THE PATIENT EXPERIENCED ANGINA AT REST. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION IN ONE OF THE TARGET LESIONS AND THE PATIENT'S CONDITION RESOLVED. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH FILED, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PERCUTANEOUS CORONARY INTERVENTION ON (B)(6) 2010, OCCURRED IN THE PROXIMAL CIRCUMFLEX - FIRST OBTUSE MARGINAL ARTERY.

    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 8062361

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R