BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 5489023 · Received March 9, 2016

    Report

    Report Number
    3004066202-2016-00073
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    November 23, 2015
    Report Date
    February 9, 2016
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). USE OF TAPERED BALLOONS TO RECANALIZE OCCLUDED BELOW-THE KNEE ARTERIES IN DIABETIC PATIENTS WITH CRITICAL. ANNALS OF VASCULAR SURGERY ANN VASC SURG 2016; 31: 105¿110 HTTP://DX.DOI.ORG/10.1016/J.AVSG.2015.08.015. JOURNAL ARTICLE: USE OF TAPERED BALLOONS TO RECANALIZE OCCLUDED BELOW-THE KNEE ARTERIES IN DIABETIC PATIENTS WITH CRITICAL. ANNALS OF VASCULAR SURGERY ANN VASC SURG 2016; 31: 105¿110 HTTP://DX.DOI.ORG/10.1016/J.AVSG.2015.08.015.

    Description of Event or Problem · 1

    BACKGROUND: THE AIM OF THIS STUDY WAS TO EVALUATE THE OUTCOME OF TAPERED BALLOON USE IN RECANALIZATION OF LONG OCCLUSIONS OF BELOW-THE-KNEE (BTK) ARTERIES IN DIABETIC PATIENTS WITH CRITICAL LIMB ISCHEMIA (CLI). METHODS: FORTY-NINE OCCLUDED BTK ARTERIES IN 35 DIABETIC PATIENTS WITH CLI WERE REVASCULARIZED IN OUR DIABETIC FOOT CENTER BETWEEN JANUARY AND SEPTEMBER 2014 USING TAPERED BALLOONS. TWELVE-MONTH OUTCOMES WERE EVALUATED IN TERMS OF HEALING OF THE LESIONS, SURVIVAL, LIMB SALVAGE, PRIMARY PATENCY, PRIMARY ASSISTED PATENCY, AND SECONDARY PATENCY. RESULTS: THE PATIENTS WERE PREDOMINANTLY MALE (27/35, 77.1%) WITH A MEAN AGE OF 70.9 YEARS (+/- 10.3 STANDARD DEVIATION [SD]). DURING THE FOLLOW-UP (MEAN DURATION 12.4 MONTHS +/- 4 SD), HEALING OF THE LESIONS WAS OBTAINED IN 27 OF THE 35 CASES (77.1%). ESTIMATED 12-MONTH SURVIVAL AND LIMB SALVAGE WERE 85.7% AND 91.1%, RESPECTIVELY. ESTIMATED 12-MONTH PRIMARY PATENCY, PRIMARY ASSISTED PATENCY, AND SECONDARY PATENCY WERE 78.3%, 79%, AND 88.9%, RESPECTIVELY. UNIVARIATE ANALYSIS DEMONSTRATED THAT THE PRESENCE OF CHRONIC RENAL FAILURE AFFECTED SURVIVAL (P 1/4 .005), AND ASSIGNMENT TO RUTHERFORD CLASS 6 AFFECTED LIMB SALVAGE (P 1/4 .005), PRIMARY PATENCY (P <(><<)> 0.001), AND PRIMARY ASSISTED PATENCY (P <(> <<)> 0.001). FURTHERMORE, THE PRESENCE OF CORONARY ARTERY DISEASE AFFECTED PRIMARY PATENCY (P 1/4 .001) AND PRIMARY ASSISTED PATENCY (P 1/4 0.05). CONCLUSIONS: TAPERED BALLOONS ARE A SAFE AND EFFECTIVE MEANS TO RECANALIZE LONG OCCLUSIONS OF BTK ARTERIES IN DIABETIC PATIENTS WITH CLI. OUTCOMES ARE POORER IN PATIENTS WITH MAJOR TISSUE LOSS AND WITH A HISTORY OF CORONARY ARTERY DISEASE. FURTHER EXPERIENCE WITH LARGER GROUPS IS NEEDED TO VALIDATE THESE OUTCOMES. FORTY-NINE OCCLUDED BTK ARTERIES IN 35 DIABETIC PATIENTS WITH CLI WERE REVASCULARIZED IN OUR DIABETIC FOOT CENTER BETWEEN JANUARY AND SEPTEMBER 2014 USING TAPERED BALLOONS (AMPHIRION DEEP; MEDTRONIC, INC., (B)(4)). THE TAPERED BALLOON USED TO PERFORM THE ANGIOPLASTY HAD A MAXIMUM DIAMETER OF 2.5 MM (2E 2.5 _ 210 MM) IN 15 CASES (30.6%) AND 3 MM (2.5E3 _ 210 MM) IN THE REMAINING 34 CASES (69.4%). TECHNICAL SUCCESS WAS ACHIEVED IN 44 OF THE 49 VESSELS (89.8%). IN 4 VESSELS, THE OCCLUDED BTK ARTERY WAS NOT REVASCULARIZED UNTIL THE FOOT, WHILE IN 1 VESSEL AN ACUTE RECOIL WITH THROMBOSIS OCCURRED. NO PROVISIONAL STENTING WAS PERFORMED. AT 30 DAYS, 3 MAJOR COMPLICATIONS OCCURRED (8.6%). THESE CONSISTED OF 1 CASE OF POSTOPERATIVE MYOCARDIAL INFARCTION, 1 CASE OF ACUTE LIMB ISCHEMIA TREATED WITH LOCOREGIONAL THROMBOLYSIS AND DISTAL BYPASS GRAFTING, AND 1 CASE OF LEG AMPUTATION. DURING THE FOLLOW-UP, 5 PATIENTS DIED (1 CEREBRAL HEMORRHAGE, 2 ACUTE HEART FAILURE, 2 CANCER). ESTIMATED 12-MONTH SURVIVAL WAS 85.7%. FURTHERMORE, OTHER 2 PATIENTS UNDERWENT MAJOR AMPUTATION (1 LEG AND 1 ABOVE-THE-KNEE). ESTIMATED 12-MONTH LIMB SALVAGE WAS 91.1%. ABOUT THE REVASCULARIZED BTK ARTERIES, THE ESTIMATED 12-MONTH PRIMARY PATENCY, PRIMARY ASSISTED PATENCY, AND SECONDARY PATENCY WERE 78.3%, 79%, AND 88.9%, RESPECTIVELY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145183 AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS DQY INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention