BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6393818 · Received March 9, 2017

    Report

    Report Number
    2024168-2017-01988
    Event Type
    Injury
    Date Received
    March 9, 2017
    Date of Event
    February 10, 2017
    Report Date
    March 9, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648199578
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: SION, SION BLUE; GUIDE CATHETER: HYPERION SAL 7F, STENT: XIENCE ALPINE 3.0X18MM, 4.0 X28MM, GRAFTMASTER 2.8X19MM. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, HYPOTENSION AND ARTERIAL PERFORATION ARE LISTED IN THE XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULT TO POSITION CANNOT BE DETERMINED. ADDITIONALLY, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE 2.8 X 19 GRAFTMASTER IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED, DE NOVO AND ECCENTRIC PROXIMAL RIGHT CORONARY ARTERY (RCA) THAT WAS 90% STENOSED. PRE-DILATATION WAS PERFORMED WITH TWO NON-ABBOTT BALLOON CATHETERS. A 3.0 X 18 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE DISTAL RCA, A 3.5 X 38 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE MID RCA AND A 4.0 X 28 MM XIENCE ALPINE STENT WAS DEPLOYED IN THE PROXIMAL RCA. THE 3.0 X 18 MM AND 3.5 X 38 MM STENTS WERE NOT OVERLAPPED, THE 3.5 X 38 MM AND 4.0 X 28 MM WERE OVERLAPPED. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED MULTIPLE TIMES BEFORE AND AFTER DEPLOYING THE STENTS. IT WAS CONFIRMED THERE WAS NO MALPOSITION OF THE 3.5 X 38 MM XIENCE ALPINE; HOWEVER, IT WAS OVAL SHAPED DUE TO THE CALCIFIED LESION. ANGIOGRAPHY WAS PERFORMED DUE TO THE PATIENT BLOOD PRESSURE DECLINING AND A PERFORATION WAS NOTED WHERE THE 3.5 X 38 MM XIENCE ALPINE WAS IMPLANTED. PERICARDIOCENTESIS WAS PERFORMED AND A 2.8 X 19 MM GRAFTMASTER COVERED STENT SYSTEM WAS ADVANCED BUT COULD NOT CROSS THROUGH THE IMPLANTED 3.5 X 38 MM XIENCE ALPINE AND WHEN REMOVED FROM THE ANATOMY THE EDGE OF THE STENT WAS FLARED. A GUIDELINER WAS ADVANCED AND A 2.8 X 16 MM GRAFTMASTER WAS DEPLOYED TO COVER THE PERFORATION. THERE WAS NO LEAK NOTED. AN ADDITIONAL 3.5 X 16 MM GRAFTMASTER STENT WAS DEPLOYED OVERLAPPING THE PROXIMAL END OF THE 3.5 X 38 MM XIENCE ALPINE. POST-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER AND IVUS WAS PERFORMED TO CONFIRM THERE WAS NO BLOOD LEAK WHICH COMPLETED THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174966 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6110141 08717648199578

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention