BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK BTK

    MDR report key: 6483702 · Received April 11, 2017

    Report

    Report Number
    2183870-2017-00163
    Event Type
    Injury
    Date Received
    April 11, 2017
    Date of Event
    January 14, 2017
    Report Date
    March 13, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MCW
    PMA / PMN Number
    K061188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT EVENT: MEAN AGE/MEAN GENDER DATE OF EVENT: ESTIMATE OF WHEN EVENTS BEGAN JOURNAL: LONG-TERM OUTCOMES AFTER PERCUTANEOUS LOWER EXTREMITY ARTERIAL INTERVENTIONS WITH ATHERECTOMY VS BALLOON ANGIOPLASTY. CIRC J 2017; 81: 376 ¿ 382 DOI: 10.1253/CIRCJ.CJ-16-0856.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PURPOSE OF THIS JOURNAL ARTICLE WAS TO STUDY LONG-TERM OUTCOMES AFTER PERCUTANEOUS LOWER EXTREMITY ARTERIAL INTERVENTIONS WITH ATHERECTOMY VS BALLOON ANGIOPLASTY. IT IS REPORTED THAT SILVERHAWK AND 2 NON- MEDTRONIC DEVICES WERE USED FOR ATHERECTOMY (AT) PROCEDURES. THIS WAS A SINGLE-CENTER, RETROSPECTIVE REGISTRY OF OBSTRUCTIVE AND SYMPTOMATIC PERIPHERAL ARTERY DISEASE (PAD) PATIENTS WHO UNDERWENT ENDOVASCULAR REVASCULARIZATION. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED IN 215 PATIENTS, AND AT IN 204. THERE WERE NO SIGNIFICANT BETWEEN-GROUP DIFFERENCES IN BASELINE CHARACTERISTICS EXCEPT FOR INCREASED CAD, DIALYSIS AND CLI PREVALENCE IN THE PTA GROUP. IT WAS CONCLUDED THAT AT WAS ASSOCIATED WITH LOWER RISK OF TARGET LESION REVASCULARIZATION (TLR), AND THIS SHOULD BE CONFIRMED IN RANDOMIZED CONTROLLED TRIALS. BAIL-OUT STENTING WAS MORE FREQUENT IN THE REFERENCE GROUP. AT 6- AND 12-MONTH FOLLOW-UP THERE WERE NO DIFFERENCES IN TLR BETWEEN THE GROUPS. THE DIFFERENCE WAS IN FAVOR OF AT 24-MONTH FOLLOW-UP. NO DIFFERENCE WAS OBSERVED IN AMPUTATION RATE. ON KAPLAN-MEIER ANALYSIS THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS IN TIME TO TLR, AMPUTATION OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265286 SILVERHAWK BTK CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN (IRVINE)

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention| S