BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAWKONE

    MDR report key: 6639830 · Received June 14, 2017

    Report

    Report Number
    2183870-2017-00254
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    December 23, 2016
    Report Date
    May 15, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MCW
    PMA / PMN Number
    K141801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT EVENT: MEAN AGE. DATE OF EVENT: ESTIMATE OF WHEN EVENTS BEGAN TITLE OF ARTICLE: DIRECTIONAL ATHERECTOMY WITH ANTIRESTENOTIC THERAPY VS DRUG-COATED BALLOON ANGIOPLASTY ALONE FOR ISOLATED POPLITEAL ARTERY LESIONS JOURNAL OF ENDOVASCULAR THERAPY 2017, VOL. 24(2) 181-188 DOI: 10.1177/1526602816683933 WWW.JEVT.ORG. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A STUDY WAS CONDUCTED TO REPORT A SINGLE-CENTER STUDY COMPARING DRUG-COATED BALLOON (DCB) ANGIOPLASTY VS DIRECTIONAL ATHERECTOMY WITH ANTIRESTENOTIC THERAPY (DAART) FOR ISOLATED LESIONS OF THE POPLITEAL ARTERY. SEVENTY-TWO (72) SYMPTOMATIC PAD PATIENTS WITH AN AVERAGE AGE OF 72 YEARS, WITH A HISTORY OF HYPERTENSION, DIABETES MELLITUS, DYSLIPIDEMIA, CORONARY HEART DISEASE, CHRONIC KIDNEY DISEASE AND CEREBROVASCULAR DISEASE. THE PATIENTS WERE TREATED AT A SINGLE CENTER BETWEEN OCTOBER 2009 AND DECEMBER 2015 FOR ISOLATED POPLITEAL LESIONS. IN.PACT ADMIRAL, IN.PACT PACIFIC, SPIDER, TURBOHAWK, SILVERHAWK, HAWKONE ATHERECTOMY DEVICES WERE USED FOR THE PROCEDURES. THE DCB PATIENTS PRESENTED WITH DISTAL EMBOLIZATION, PERFORATED VESSEL WALL, FALSE ANEURYSM, HEMATOMA AND TARGET LESION REVASCULARIZATION (TLR). THE DAART PATIENTS PRESENTED WITH DISTAL EMBOLIZATION, PERFORATED VESSEL WALL, FALSE ANEURYSM, HEMATOMA, TLR, ANEURYSM, RE-OCCLUSION, 1 PATIENT DIED OF UNKNOWN CAUSES. ADDITIONALLY, PHYSICIAN REPORTED THAT THE DEATH OF 1 PATIENT WAS NOT RELATED TO THE DAART PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421322 HAWKONE CATHETER, PERIPHERAL, ATHERECTOMY MCW COVIDIEN (IRVINE) UNK-PLY-HAWKONE

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention