BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE ALPINE

    MDR report key: 20324451 · Received September 27, 2024

    Report

    Report Number
    2024168-2024-11438
    Event Type
    Death
    Date Received
    September 27, 2024
    Date of Event
    September 1, 2024
    Report Date
    September 27, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, AN ELECTRONIC LOT HISTORY RECORD (ELHR) REVIEW AND A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBER WAS NOT REPORTED. THE REPORTED PATIENT EFFECT OF DEATH, IS LISTED IN THE XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF A STENT IN NATIVE CORONARY OR PERIPHERAL ARTERIES. THE INFORMATION RECEIVED IN THE COMPLAINT WAS OBTAINED THROUGH A PROACTIVE LITERATURE SEARCH. SPECIFIC MODEL AND LOT NUMBERS WERE NOT AVAILABLE AND CAUSALITY BETWEEN THE DOCUMENTED DEVICE USAGE AND THE PATIENT EFFECTS COULD NOT BE ESTABLISHED. THE PATIENT EFFECTS LISTED ARE CONSISTENT WITH THE PRODUCT RISK PROFILE AND ARE THEREFORE EXPECTED. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. B2: DATE OF DEATH ESTIMATED AS (B)(6) 2024 B3: DATE OF EVENT ESTIMATED AS (B)(6) 2024. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED D6A: IMPLANT DATE ESTIMATED AS (B)(6) 2024. LITERATURE: ARTICLE TITLE "OPTICAL COHERENCE TOMOGRAPHY-GUIDED VERSUS ANGIOGRAPHYGUIDED PERCUTANEOUS CORONARY INTERVENTION FOR PATIENTS WITH COMPLEX LESIONS (OCCUPI): AN INVESTIGATOR-INITIATED, MULTICENTRE, RANDOMISED, OPEN-LABEL, SUPERIORITY TRIAL IN SOUTH KOREA" THE ADDITIONAL PATIENT EFFECTS REPORTED IN THE ARTICLE ARE CAPTURED UNDER A SEPARATE MEDWATCH REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED VIA LITERATURE REVIEW: PERCUTANEOUS CORONARY INTERVENTION WAS DONE ACCORDING TO CONVENTIONAL STANDARD METHODS WITH EVEROLIMUS-ELUTING STENTS (XIENCE ALPINE OR XIENCE SIERRA). IN THE OPTICAL COHERENCE TOMOGRAPHY (OCT)-GUIDANCE GROUP, LESION CHARACTERISTICS FOR DEVICE SIZING AND LANDING AND STENT OPTIMISATION WERE ASSESSED UNDER OCT GUIDANCE. POST-STENTING OCT EVALUATION (TO ASSESS WHETHER OPTIMISATION CRITERIA WERE FULFILLED) WAS STRONGLY RECOMMENDED, BUT NOT MANDATED BY THE PROTOCOL. ALL OPERATORS WERE TRAINED AND WELL ACQUAINTED WITH THE PROTOCOL FOR THE OCT GUIDANCE AND PARTICIPATED IN REGULAR INVESTIGATOR MEETINGS. THE FOLLOWING ADVERSE PATIENT EFFECTS WERE REPORTED AGAINST THE XIENCE ALPINE OR XIENCE SIERRA; DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS, TARGET LESION REVASCULARIZATION, STROKE, DISSECTION, ISCHAEMIA DRIVEN REVASCULARIZATION AND BLEEDING. DETAILS ARE LISTED IN THE ARTICLE, TITLED "OPTICAL COHERENCE TOMOGRAPHY-GUIDED VERSUS ANGIOGRAPHY GUIDED PERCUTANEOUS CORONARY INTERVENTION FOR PATIENTS WITH COMPLEX LESIONS (OCCUPI): AN INVESTIGATOR-INITIATED, MULTICENTRE, RANDOMISED, OPEN-LABEL, SUPERIORITY TRIAL IN SOUTH KOREA." NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831605 XIENCE ALPINE CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR INC. UNK RX ALPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death