BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 8381474 · Received March 1, 2019

    Report

    Report Number
    9612164-2019-00707
    Event Type
    Death
    Date Received
    March 1, 2019
    Date of Event
    December 15, 2018
    Report Date
    March 1, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE ARTICLE ACCEPTED JOURNAL ARTICLE TITLE: DESIGN AND RATIONALE OF A RANDOMIZED NONINFERIORITY TRIAL TO EVALUATE THE SURVEIL DRUG-COATED BALLOON IN SUBJ ECTS WITH STENOTIC LESIONS OF THE FEMOROPOPLITEAL ARTERY ¿ THE TRANSCEND STUDY AMERICAN HEART JOURNAL VOLUME 209, NUMBER 0 © 2018 ELSEVIER INC. ALL RIGHTS RESERVED. HTTPS://DOI.ORG/10.1016/J.AHJ.2018.12.012. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    BACKGROUND DRUG-COATED BALLOONS (DCBS), DEVELOPED TO REDUCE RESTENOSIS AFTER PERCUTANEOUS INTERVENTION IN PERIPHERAL ARTERIAL DISEASE (PAD), HAVE BEEN SHOWN TO BE SAFE AND EFFICACIOUS, PARTICULARLY IN TREATING PAD AFFECTING THE FEMOROPOPLITEAL SEGMENT. THE SURVEIL DCB USES AN EXCIPIENT INTENDED TO OPTIMIZE BOTH THE UNIFORMITY AND TRANSFER OF PACLITAXEL TO THE VESSEL WALL, ALLOWING FOR EFFICIENT DRUG LOADING AND LOWER SYSTEMIC EXPOSURE THAN CURRENTLY AVAILABLE DCBS, HERETOFORE, CLINICAL OUTCOMES HAVE NOT PREVIOUSLY BEEN COMPARED TO OTHER DCBS. STUDY DESIGN AND OBJECTIVES THIS PROSPECTIVE, MULTICENTER, INTERNATIONAL, RANDOMIZED, SINGLE-BLIND, TRIAL WILL COMPARE 1:1 THE SURVEIL DCB WITH THE IN.PACT ADMIRAL DCB FOR TREATMENT OF PATIENTS WITH RUTHERFORD CLASSIFICATION 2 TO 4 DUE TO FEMORAL AND/OR POPLITEAL ARTERIAL DISEASE. THE TRIAL WILL RANDOMIZE 446 SUBJECTS (WITH REFERENCE VESSEL DIAMETER 4¿7 MM AND TOTAL LESION LENGTH =180 MM). SUBJECTS WILL BE FOLLOWED FOR 60 MONTHS. THE PRIMARY EFFICACY ENDPOINT IS 1 YEAR PRIMARY PATENCY, DEFINED AS COMP OSITE FREEDOM FROM CLINICALLY-DRIVEN TARGET-LESION REVASCULARIZATION (TLR) AND BINARY RESTENOSIS (CORE LAB-ADJUDICATED DUPLEX ULTRASOUND PEAK SYSTOLIC VELOCITY RATIO =2.4, OR =50% STENOSIS VIA ANGIOGRAPHY). THE PRIMARY SAFETY ENDPOINT IS COMPOSITE FREEDOM FROM DEV ICE- AND PROCEDURE-RELATED DEATH THROUGH 30 DAYS AND FREEDOM FROM TARGET LIMB MAJOR AMPUTATION AND CLINICALLY-DRIVEN TARGET VESSEL REVASCULARIZATION THROUGH 12 MONTHS. THE PRIMARY ANALYSIS IS A TEST OF NONINFERIORITY OF THE SURVEIL VS. IN.PACT ADMIRAL ON THE PRIMARY EFFICACY AND SAFETY ENDPOINTS ACCORDING TO ABSOLUTE DELTAS OF 15.0% AND 10.0%, RESPECTIVELY. CONCLUSION THE RANDOMIZED AND CONTROLLED NONINFERIORITY TRIAL TO EVALUATE SAFETY AND CLINICAL EFFICACY OF THE SURVEIL DCB IN THE TREATMENT OF SUBJECTS WITH STENOTIC LESIONS OF THE FEMOROPOPLITEAL ARTERY COMPARED TO THE MEDTRONIC IN.PACT ADMIRAL (TRANSCEND) STUDY WILL ASSESS SAFETY AND EFFICACY OF THE SURVEIL DCB RELATIVE TO A COMMONLY USED DCB. THREE DCBS ARE CURRENTLY APPROVED BY THE FDA FOR TREATMENT OF PAD INVOLVING THE FEMOROPOPLITEAL ARTERY, THE LUTONIX 035 PACLITAXEL-COATED BALLOON CATHETER, THE MEDTRONIC IN.PACT ADMIRAL PACLITAXEL-COATED BALLOON CATHETER, AND THE SPECTRANETICS STELLAREX DRUG-COATED ANGIOPLASTY BALLOON CATHETER. THE LUTONIX DCB CATHETER WAS EVALUATED WITHIN THE LUTONIX PACLITAXEL-COATED BALLOON FOR THE PREVENTION OF FEMOROPOPLITEAL RESTENOSIS (LEVANT) 2 TRIAL, IN WHICH 476 PATIENTS WERE RANDOMIZED IN A 2:1 RATIO TO A DCB COATED WITH PACLITAXEL VS. PTA. AT 12 MONTHS, PRIMARY PATENCY (FREEDOM FROM BINARY RESTENOSIS OR FROM TLR) WAS ACHIEVED IN 65.2% OF PATIENTS RECEIVING DCB VS. 52.6% OF PATIENTS RECEIVING PTA (P = .02), AND 83.9% VS. 79.0%, RESPECTIVELY, WERE FREE FROM PRIMARY SAFETY EVENTS (NONINFERIORITY P = .005).20 IN THE SIMILARLY DESIGNED IN.PACT SFA TRIAL, 331 PATIENTS WERE RANDOMIZED IN A 2:1 RATIO TO A DCB COATED WITH PACLITAXEL VS. PTA. AT 12 MONTHS, PRIMARY PATENCY WAS ACHIEVED IN 82.2% OF PATIENTS RECEIVING DCB VS. 52.4% OF PATIENTS RECEIVING PTA (P B .001).21 AT 36 MONTHS, TREATMENT WITH THE IN.PACT DCB WAS ASSOCIATED WITH PERSISTENTLY INCREASED PRIMARY PATENCY (69.5%) COMPA RED WITH PTA (45.1%, P B .001), AND REDUCED CLINICALLY-DRIVEN TLR (15.2% VS. 31.1%, RESPECTIVELY, P = .002).30 WITHIN THE PROSPECTIVE, RANDOMIZED, SINGLEBLIND, U.S. MULTI-CENTER STUDY TO EVALUATE TREATMENT OF OBSTRUCTIVE SUPERFICIAL FEMORAL ARTERY OR POPLITEAL LESIONS WITH A NOVEL PACLITAXEL-COATED PERCUTANEOUS ANGIOPLASTY BALLOON (ILLUMENATE) PIVOTAL STUDY, THE SPECTRANETICS STELLAREX DCB WAS COMPARED TO STANDARD ANGIOPLASTY WITHIN 300 PATIENTS RANDOMIZED IN A 2:1 FASHION. PRIMARY PATENCY WAS SIGNIFICANTLY HIGHER WITH THE STELLAREX DCB COMPARED TO PTA (82.3% VS. 70.9%; P = .002).22 IN A METAANALYSIS OF 7 RANDOMIZED TRIALS INCLUDING 1230 PATIENTS COMPARING DCBS TO UNCOATED BALLOON ANGIOPLASTY IN PATIENTS WITH PAD OF THE FEMOROPOPLITEAL ARTERY, DCBS WERE ASSOCIATED WITH REDUCED TLR (ODDS RATIO [OR] 0.26, 95% CI 0.13¿0.56), BUT NO DIFFERENCES IN RATES OF BINARY RESTENOSIS (OR 0.37, 95% CI 0.11¿1.26), AMPUTATION (OR 2.21, 95% CI 0.23¿21.51), OR DEATH (OR 0.67, 95% CI 0.31¿1.46).1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175153 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death