BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4560793 · Received March 2, 2015

    Report

    Report Number
    2024168-2015-01120
    Event Type
    Injury
    Date Received
    March 2, 2015
    Date of Event
    February 9, 2015
    Report Date
    February 17, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 3.5X12 MM RX XINCE ALPINE AND THE 3.5X8 MM RX XIENCE ALPINE STENTS REFERENCED ARE FILED UNDER SEPARATE MEDWATCH REPORTS. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE, IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ANGINA AND DURING A PROCEDURE TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA), AN OSTIAL DISSECTION OCCURRED PRIOR TO BALLOON INFLATION WHICH BACKED UP INTO THE AORTIC ROOT. BALLOON INFLATION WAS PERFORMED. A 3.0X18 MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND THE STENT WAS IMPLANTED FOLLOWED BY A 3.5X12 MM RX XIENCE ALPINE SDS BEING ADVANCED AND THE STENT IMPLANTED PROXIMALLY TO THE OSTIUM OF THE RCA. WHERE THE STENTS OVERLAPPED WAS POST-DILATED TO 3.5 AND PROXIMAL STENT DILATED TO 3.5 AT THE OSTIUM. DESPITE THE STENTS, THERE REMAINED A LEAK INTO A DISSECTION POUCH ADJACENT TO THE RCA OSTIUM. REPORTEDLY, THE DISSECTION SPIRALED. EMERGENCY ECHO WAS PERFORMED TO EXCLUDE PERICARDIAL FLUID AND/OR ACUTE AORTIC INSUFFICIENCY, NEITHER OF WHICH WAS SEEN. A SMALL LEAK WAS NOTED AT THE BORDER OF THE RCA OSTIUM AND A 3.5X8 MM RX XIENCE ALPINE STENT WAS IMPLANTED AND THE DISSECTION CONTINUED TO LEAK INTO SUB INTIMAL SPACE. A 3.5X16 MM GRAFTMASTER STENT WAS IMPLANTED, DILATED TO 4 MM AT 16 ATMOSPHERES IN THE PROXIMAL PORTION OF THE RCA EXTENDING INTO THE AORTIC ROOT BY 2 MM TO SUCCESSFULLY TREAT THE DISSECTION WITHOUT ANY ISSUES. THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EMERGENT NEED TO USE THE GRAFTMASTER STENT. POST PROCEDURE THE PATIENT WAS SENT TO THE CARDIAC CARE UNIT UNSTABLE. ON (B)(6) 2015, THE PATIENT HAD AN ADDITIONAL PERCUTANEOUS CORONARY INTERVENTION TO TREAT A LESION IN THE CIRCUMFLEX ARTERY AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION TO HOME ON (B)(6) 2015. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143709 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4092661

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R