BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK ATK

    MDR report key: 19060083 · Received April 8, 2024

    Report

    Report Number
    9612164-2024-01654
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    May 6, 2014
    Report Date
    April 8, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MCW
    PMA / PMN Number
    K061188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE REF: DOI 10.1007/S00270-014-0884-3 A2: AVERAGE AGE 3A: MAJORITY SEX MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED AN ARTICLE 'THREE-YEAR RESULTS AFTER DIRECTIONAL ATHERECTOMY OF CALCIFIED STENOTIC LESIONS OF THE SUPERFICIAL FEMORAL ARTERY'. IN TOTAL, 59 LESIONS (4 PATIENTS WITH BILATERAL LESIONS) WERE TREATED WITH THE SILVERHAWK ATHERECTOMY DEVICE. IN TWO CASES, PREVIOUS BALLOON DILATATION WITH A 3-MM BALLOON CATHETER (PACIFIC XTREME) WAS REQUIRED TO ADVANCE THE SILVERHAWK CATHETER. THE PRIMARY TECHNICAL SUCCESS RATE WAS 92 %. ADDITIONAL BALLOON- AND STENT-PTA WAS NECESSARY IN FIVE CASES RESULTING IN AN ASSISTED PRIMARY TECHNICAL SUCCESS RATE OF 100 %. SEVEN (12 %) PROCEDURE-RELATED EMBOLIZATIONS OCCURRED DURING THE PROCEDURE. IN SIX CASES, THE EMBOLI WAS LOCATED AT THE BIFURCATION OF THE TIBIOFIBULAR TRUNK AND IN ONE CASE IN THE PROXIMAL POSTERIOR TIBIAL ARTERY. ALL EMBOLI WERE SUCCESSFULLY TREATED BY ASPIRATION. NO MAJOR COMPLICATIONS OCCURRED DURING OR AFTER THE PROCEDURE. FOLLOW-UP DATA REPORTED 17 PATIENTS DIED, 3 PATIENTS RECEIVED BYPASS SURGERY, AND THERE WERE 1 MINOR AND 6 MAJOR AMPUTATIONS. EIGHT PATIENTS DIED DURING THE FIRST 6 MONTHS OF THE FOLLOW-UP PERIOD AND ONE PATIENT DIED DURING THE FOLLOWING 6 MONTHS; CAUSES OF DEATH WERE CEREBRAL INSULT (N 3), MYOCARDIAL INFARCTION (N 3), AND CARDIOPULMONARY INSUFFICIENCY (N 3). ONE PATIENT UNDERWENT A SURGICAL BYPASS PROCEDURE AFTER 6 MONTHS AND ANOTHER PATIENT MOVED AWAY AND WAS THEREFORE LOST TO FOLLOW-UP THE OVERALL PRIMARY PATENCY RATE WAS 55 %, AND THE ASSISTED PRIMARY PATENCY RATE WAS 75 % AFTER 3 YEARS. CLINICAL SUCCESS WAS 89 % AFTER 6 MONTHS, 84 %AFTER 12, 18, AND 24 MONTHS, 79 % AFTER 30 MONTHS, AND 75 % AFTER 36 MONTHS. THE LIMB-SALVAGE RATE AFTER 3 YEARS WAS 87 %. MAJOR AND MINOR AMPUTATIONS OF THE TREATED LIMB HAD TO BE PERFORMED IN SIX AND ONE PATIENTS, RESPECTIVELY, WHICH WERE ALL PERFORMED DURING THE FIRST 6 MONTHS AFTER THE INTERVENTION. TARGET LESION REVASCULARIZATION AND TARGET VESSEL REVASCULARIZATION HAD TO BE PERFORMED IN EIGHT AND FIVE PATIENTS, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121698 SILVERHAWK ATK CATHETER, PERIPHERAL, ATHERECTOMY MCW MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention