BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1983608 · Received February 10, 2011

    Report

    Report Number
    2024168-2011-00790
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. DISSECTION IS A KNOWN ADVERSE EVENT 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. STENTS: XIENCE V 2.5X12MM, XIENCE V 2.5X28MM, XIENCE V 3.5X15MM, XIENCE V 3.0X18MM. VASCULAR SOLUTIONS GUIDELINER, UNK BUDDY WIRE, UNK DILATATION CATHETER,6 FR SHEATH. THE XIENCE V 3.5X15MM (PART 1009542-15, LOT UNK) AND XIENCE V 3.0X18MM (PART 1009541-18, LOT UNK), ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). REMOVED XIENCE V 3.5 X 15 MM, ADDED VISION 3.5 X 15 MM. THE ADDITIONAL XIENCE V 2.5 X 12MM STENT IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS AT THE BIFURCATION OF THE CIRCUMFLEX AND OBTUSE MARGINAL ARTERY. A XIENCE V 2.5 X12MM STENT WAS SUCCESSFULLY IMPLANTED IN THE OBTUSE MARGINAL (OM) ARTERY. A XIENCE V 2.5X28MM COULD NOT CROSS THE LESION (DIRECT STENTING) PROXIMAL TO THE IMPLANTED STENT AND WAS REMOVED INTACT. DESPITE USE OF A BUDDY WIRE AND BALLOON DILATATION, THE SDS DID NOT CROSS A SECOND TIME AND WAS REMOVED. ANGIO WAS DONE AND A NON-ABBOTT, STIFF GUIDELINER WAS INSERTED ACROSS THE LESION. A RX XIENCE V 2.5X12MM WAS ADVANCED AND INFLATED AT 12 ATM X 36 SECONDS AND WAS IMPLANTED IN THE OM. A DISSECTION WAS THEN SEEN JUST ABOVE THAT STENT. THE PHYSICIAN FELT THAT THE DISSECTION WAS SECONDARY TO THE GUIDELINER, HOWEVER, THIS COULD NOT BE CONFIRMED. A RX XIENCE V 3.5X15MM STENT WAS IMPLANTED OVER THE DISSECTION, HOWEVER, THE DISSECTION WAS ENLARGING TOWARD THE LEFT MAIN ARTERY. A SECOND RX XIENCE V 3.0X18MM WAS IMPLANTED OVER THE ENLARGING DISSECTION, BUT THE DISSECTION CONTINUED TO EXPAND. THE PATIENT WAS TRANSFERRED TO SURGERY AND UNDERWENT CORONARY ARTERY BYPASS GRAFT. REPORTEDLY THE PATIENT WAS IN GOOD CONDITION POST-OPERATIVELY. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, ADDITIONAL INFORMATION RECEIVED INDICATES THE 3.5 X 15 MM STENT WAS A VISION STENT NOT XIENCE V. ADDITIONALLY ONE OTHER XIENCE V 2.5 X 12 MM WAS DEPLOYED AT 12 ATMOSPHERES FOR 14 SECONDS, AFTER THE INITIALLY REPORTED XIENCE V 2.5 X 12 MM AND BEFORE THE UNK VISION 3.5 X 15 MM WERE DEPLOYED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R| S