BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6576176 · Received May 18, 2017

    Report

    Report Number
    2024168-2017-04266
    Event Type
    Injury
    Date Received
    May 18, 2017
    Date of Event
    March 20, 2017
    Report Date
    July 13, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER REVISED FROM 4120941 TO 4121241. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE REPORTED PATIENT EFFECT OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE LISTED IN INSTRUCTIONS FOR USE XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEMS AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ATTACHMENT: SUS VOLUNTARY REPORT# MW5068936. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "ON 2015 PATIENT TRANSFERRED TO OUR FACILITY WITH USA FOR PCI OF 75 PERCENT PROXIMAL AND MID RCA. PRE-DILATED WITH 3.0 X 20 TREK. A 4.0 X 38 XIENCE ALPINE TO MID RCA AND 4.0 X 28 XIENCE ALPINE TO PROXIMAL RCA, CAREFULLY OVERLAPPED. FINAL FILMS REVEAL GOOD RESULT WITH TIMI III FLOW. PATIENT DISCHARGED. ON 2017 ON MEDICATIONS INCLUDING ASA 81 MG AND PLAVIX 75 MG TO CONTINUE FOR AT LEAST 1 YEAR. ON 2017 ARRIVAL TO OUR ER WITH STEMI. HE TOOK ASA AND PLAVIX AS DIRECTED FOR OVER 1 YEAR, UNTIL SEEING A NEW CARDIOLOGIST WHO STOPPED PLAVIX, CONTINUING ONLY ASA 81 MG. FILMS REVEAL THROMBOTIC TOTAL OCCLUSION OF PREVIOUSLY PLACED PROXIMAL RCA STENT. MULTIPLE INFLATIONS 3.0 X 15 EMERGE, 3.5 X 20 NC EMERGE, AND THROMBECTOMY PASSES WITH PRONTO V4. A 4.0 X 38 SYNERGY PLACED IN PROXIMAL RCA, POST-DILATED WITH 4.0 X 30 NC EMERGE. PROCEDURE MEDICINES INCLUDING HEPARIN, ASA, ANGIOMAX, AND BRILINTA. FINAL FILMS REVEAL GOOD RESULT WITH TIMI ILL FLOW. PATIENT DISCHARGED 2017 ON MEDICINES INCLUDING ASA 81 MG AND PLAVIX 75 MG FOR "PROTRACTED COURSE." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357879 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4121241

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention| S