BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE

    MDR report key: 9560331 · Received January 7, 2020

    Report

    Report Number
    2024168-2020-00443
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    August 8, 2018
    Report Date
    February 5, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648199356
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT-DEVICE INCOMPATIBILITY/DIFFICULT TO DEPLOY (WALL APPOSITION); HOWEVER, THE SUBSEQUENT TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. IT SHOULD BE NOTED THAT THE REPORTED PATIENT EFFECTS OF ANGINA, DYSPNEA, FATIGUE, INTIMAL DISSECTION AND STENOSIS ARE LISTED IN THE XIENCE ALPINE, EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) 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 THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2019001. THE STENT REMAINS IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2018, A 3.0X18MM (1125300-18, 8021261) XIENCE ALPINE STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY LESION. STENT MALPOSITION AND A PROXIMAL EDGE DISSECTION WAS OBSERVED. ADDITIONAL POST-DILATATION WAS PERFORMED AS TREATMENT. REPORTEDLY, FOLLOWING THE ADDITIONAL POST-DILATATION (USING THE MAXIMUM BALLOON SIZE AND MAXIMUM PRESSURE), THERE REMAINED SUB-OPTIMAL, DISTAL STENT EXPANSION. NO ADDITIONAL TREATMENT WAS PROVIDED. ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED FOR INCREASING DYSPNEA, CHEST TIGHTNESS/PAIN, AND FATIGUE. ANOTHER CARDIAC CATHETERIZATION WAS PERFORMED AND LAD IN-STENT RESTENOSIS WAS OBSERVED ALONG WITH SEVERE THREE VESSEL DISEASE. ON (B)(6) 2019, A CORONARY ARTERY BYPASS SURGERY WAS PERFORMED AS TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20932 XIENCE ALPINE DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1125300-18 8021261 08717648199356

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R| S 5FR| ASPIRIN, PRASUGREL