BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 7742918 · Received August 2, 2018

    Report

    Report Number
    9612164-2018-01938
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    April 26, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS LITERATURE ARTICLE PUBLISHED DATE DRUG-COATED BALLOON VS. CONVENTIONAL BALLOON ANGIOPLASTY IN DIALYSIS PATIENTS WITH SYMPTOMATIC FEMOROPOPLITEAL DISEASE CIRCULATION JOURNAL (2018) 82: 1908 ¿ 1916 10.1253/CIRCJ.CJ-18-0077. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    RECENT RANDOMIZED TRIALS HAVE SHOWN THE TREATMENT BENEFITS OF USE OF A DRUG-COATED BALLOON (DCB) OVER CONVENTIONAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN PATIENTS WITH FEMOROPOPLITEAL DISEASE. HOWEVER, THE EFFECTIVENESS AND SAFETY OF DCB FOR DIALYSIS PATIENTS REMAIN UNCLEAR. CONSECUTIVE DIALYSIS PATIENTS, WHO UNDERWENT PTA OR DCB FOR FEMOROPOPLITEAL DISEASE, WERE ASSESSED RETROSPECTIVELY VIA 2:1 PROPENSITY SCORE MATCHING. EFFECTIVENESS AND SAFETY ENDPOINTS, INCLUDING BINARY RESTENOSIS, CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (CD-TLR), AMPUTATIONS, MAJOR ADVERSE CARDIAC EVENTS (MACE), AND DEATHS, WERE COMPARED BETWEEN GROUPS. A TOTAL OF 278 DIALYSIS PATIENTS WITH 339 LIMBS WERE ELIGIBLE FOR MATCHING: 84 LIMBS FROM 77 PATIENTS TREATED WITH PTA AND 46 LIMBS FROM 37 PATIENTS TREATED WITH DCB WERE COMPARED AFTER MATCHING. BASELINE PATIENT AND LESION CHARACTERISTICS WERE NOT DIFFERENT BETWEEN GROUPS. PATIENTS TREATED WITH DCB HAD SIGNIFICANTLY HIGHER RATES OF FREEDOM FROM BINARY RESTENOSIS (52.4% VS. 18.6%, P<0.001) AND CD-TLR (56.4% VS. 25.9%, P=0.001) AT 2 YEARS COMPARED WITH PATIENTS TREATED WITH PTA. BOTH GROUPS HAD SIMILAR OUTCOMES FOR AMPUTATION, MACE, AND DEATH. COX PROPORTIONAL ANALYSIS SHOWED THAT TREATMENT WITH DCB WAS INDEPENDENTLY ASSOCIATED WITH A REDUCTION OF BINARY RESTENOSIS (HAZARD RATIO [HR] 0.368, P=0.001) AND CD-TLR (HR 0.390, P=0.004). THIS STUDY SUGGESTED SUPERIOR 2-YEAR OUTCOMES USING DCB COMPARED WITH PTA AND SIMILAR SAFETY PROFILES IN DIALYSIS PATIENTS WITH FEMOROPOPLITEAL DISEASE. 25 PATIENTS WERE TREATED USING AN IN.PACT ADMIRAL DEVICE TO CONVEY THE BENEFITS OF USING A DCB OVER PTA FOR FEMOROPOPLITEAL RELATED DISEASES. IN THE DCB GROUP, PREDILATATION WITH AN UNDERSIZED, SHORTER, UNCOATED BALLOON WAS PERFORMED AFTER CROSSING THE LESION WITH A GUIDEWIRE, FOLLOWED BY INSERTION OF A DCB OF APPROPRIATE SIZE AND LENGTH THE INFLATION TIME OF THE DCBS WAS 180S USING NOMINAL PRESSURE TO ALLOW FULL DRUG ELUTION THE MEAN LESION LENGTH WAS 198.1MM. BAILOUT BARE-METAL NITINOL STENTS WERE IMPLANTED IN CASES OF SUBOPTIMAL ANGIOGRAPHIC RESULT OR FLOW-LIMITING DISSECTION, DETERMINED BY RESIDUAL DIAMETER STENOSIS. FOLLOWING EVT, ASPIRIN WAS CONTINUED INDEFINITELY IN ALL PATIENTS. CLOPIDOGREL WAS USED FOR A MINIMUM DURATION OF 3 MONTHS IN PATIENTS RECEIVING NITINOL STENT IMPLANTATION OR DCB TREATMENT. FOLLOWING A 2 YEAR FOLLOW UP THE RATES OF FREEDOM FROM BINARY RESTENOSIS AND CD-TLR (TARGET LESION REVASCULARIZATION) WERE SIGNIFICANTLY HIGHER IN THE DCB GROUP COMPARED WITH THE PTA GROUP NO DIFFERENCES WERE OBSERVED IN THE RATES OF FREEDOM FROM MACE MAJOR ADVERSE CARDIAC EVENT), MINOR AMPUTATION, MAJOR AMPUTATION AND ALL-CAUSE DEATH BETWEEN THE 2 GROUPS. IT WAS ALSO DETERMINED POST OPERATION ADMINISTRATION OF SATINS AND CILOSTAZOL WERE NEGATIVE INDEPENDENT FACTOR OF 2 YEAR BINARY RESTENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587134 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention