BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 20199142 · Received September 12, 2024

    Report

    Report Number
    2024168-2024-10713
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    January 1, 2020
    Report Date
    October 1, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF PROCEDURE ESTIMATED AS (B)(6) 2020. D4- THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) DATABASE WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A REVIEW OF PRODUCTION RECORDS AND THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE PART/LOT NUMBERS WERE NOT REPORTED. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    THE AIM OF THE STUDY IS TO EVALUATE THE SAFETY AND EFFECTIVENESS OF ROTATIONAL ATHERECTOMY ASSISTED BALLOON ANGIOPLASTY (BTK-RA) FOR THE TREATMENT OF ISOLATED BELOW THE KNEE (BTK) ATHEROSCLEROTIC LESIONS AND TO COMPARE THE OUTCOMES TO PLAIN OLD BALLOON ANGIOPLASTY (POBA). BETWEEN JANUARY 2020 AND SEPTEMBER 2023, 96 CONSECUTIVE PATIENTS WITH CHRONIC LIMB THREATENING ISCHEMIA (CTLI) AND ISOLATED BTK-LESIONS UNDERWENT POBA (GROUP A) OR BTK-RA (GROUP B). FIFTY CONSECUTIVE PATIENTS RECEIVED POBA AND WERE ENROLLED IN GROUP A, WHILE THE REMAINING 46 CONSECUTIVE PATIENTS RECEIVED BTK-RA AND WERE ENROLLED IN GROUP B. THE LESION WAS CROSSED WITH AN 0.018 V18 CONTROL OR 0.014 HT PROCEED GUIDE WIRES. THE PHOENIX ROTATIONAL ATHERECTOMY SYSTEM TM (PHILIPS, SAN DIEGO, CA, USA) WITH A CALIBER OF 1,5 AND 1,8 MM WAS USED FOR THE BTK-RA CASES. ROUTINE USE OF POBA WAS ADDITIONALLY PERFORMED AFTER BTK-RA. A BALLOON-EXPANDABLE EVEROLIMUS-COATED BTK STENT (XIENCE PRIME, ABBOTT) WAS USED IN OSTIAL SHORT LESIONS. MEAN FOLLOW-UP OF BTK-RA WAS 7.9 MONTHS. TARGET LESION REVASCULARIZATION, OCCLUSION, AND MINOR AMPUTATION (REQUIRING SURGICAL INTERVENTION AND HOSPITALIZATION) WERE NOTED. THE ARTICLE CONCLUDED THE USE OF BTK-RA FOR THE TREATMENT OF BTK-LESIONS IN PATIENTS WITH CTLI SHOWED SIGNIFICANT CLINICAL ADVANTAGES IN COMPARISON TO POBA. DETAILS ARE LISTED IN THE ARTICLE TITLED, ¿USE OF ROTATIONAL ATHERECTOMY-ASSISTED BALLOON ANGIOPLASTY IN THE TREATMENT OF ISOLATED BELOW-THE-KNEE ATHEROSCLEROTIC LESIONS IN PATIENTS WITH CHRONIC LIMB-THREATENING ISCHEMIA". NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505833 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR UNK RX PRIME

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention| H| O