BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 5272087 · Received December 7, 2015

    Report

    Report Number
    2024168-2015-07344
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    November 14, 2015
    Report Date
    December 7, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE VESSEL. IT IS INDICATED THAT THE STENT DELIVERY SYSTEM IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS; HOWEVER, THE DIFFICULT TO DEPLOY AND ADDITIONAL TREATMENT AND HOSPITALIZATION APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. 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 OF THE REPORTED LOT DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE REPORTED PATIENT EFFECTS OF ANGINA AND THROMBOSIS, AS LISTED IN THE XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE OTHER XIENCE ALPINE STENT REFERENCED IS FILED UNDER A SEPARATE MEDWATCH MFR REFERENCE NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2015 EMERGENTLY WITH CHEST PAIN NOTED AS A NON-ST ELEVATION MYOCARDIAL INFARCTION. ON (B)(6) 2015, AFTER DIAGNOSTIC ANGIOGRAPHY, THE PATIENT UNDERWENT CORONARY ARTERY STENTING OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH THE IMPLANTATION OF A 2.25 X 28 MM AND A 2.75 X 23 MM XIENCE ALPINE STENTS. ON (B)(6) 2015, ONE DAY POST PROCEDURE, THE PATIENT AGAIN HAD CHEST PAINS AND ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND (IVUS) REVEALED THROMBUS IN ALL THE STENTS AND THEY APPEARED UNDERSIZED IN THE VESSEL. AN NC TREK BALLOON AT UNSPECIFIED HIGH PRESSURE WAS USED AS TREATMENT OF THE STENTS AFTER ASPIRATION OF THE THROMBUS. THE PATIENT WAS REPORTED IN GOOD CONDITION AND THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802664 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 5033141

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention