BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL

    MDR report key: 6799766 · Received August 17, 2017

    Report

    Report Number
    9612164-2017-01119
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    May 15, 2017
    Report Date
    July 18, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS RELATED TO A JOURNAL ARTICLE THAT HIGHLIGHT THE CONTEMPORARY ROLE OF STENTS AND ANGIOPLASTY FOR THE TREATMENT OF IN FRAPOPLITEAL DISEASE IN CRITICAL LIMB ISCHEMIA. THIS REVIEW HIGHLIGHTS THE DEBATE-BTK TRIAL ¿ A RANDOMIZED TRIAL COMPRISING OF 158 DIABETICS WITH DE NOVO LESIONS INCLUDING 78% CTOS BELOW-THE-KNEE AND AIMED TO COMPARE THE IN.PACT AMPHIRION DCB WITH CONVENTIONAL PTA. AT 1 YEAR FOLLOW-UP THE DCB GROUP HAD A LOWER RATE OF BINARY RESTENOSIS AND TLR. THERE WAS NO INCREASE IN AMPUTATIONS NOTED IN THE DCB ARM. ALSO REVIEWED IS THE IN.PACT DEEP TRIAL WHICH AIMED TO EVALUATE DCB THERAPY WITH CONVENTIONAL PTA IN CLI 358 PATIENTS. IT IS REPORTED THAT THERE WAS NO DIFFERENCE BETWEEN DCB AND PTA IN THE PRIMARY EFFICACY ENDPOINT AND LATE LUMEN LOSS. MAJOR AMPUTATION-FREE SURVIVAL AT 12 MONTHS WAS 81.1 AND 89.2% (P = 0.057), RESPECTIVELY, IN THE DCB AND PTA ARMS. NO DEVICE WAS RECEIVED FOR THE TECHNICAL ANALYSIS; HOWEVER, NO DEVICE MALFUNCTION WAS CLAIMED. RESTENOSIS IS A POSSIBLE ADVERSE EFFECTS ASSOCIATED WITH THE USE OF THE IN.PACT AMPHIRION BALLOON CATHETER IN THE IFU (0110091 REV01). BASED ON THESE CONSIDERATIONS, THE FMECA IN THE PRODUCT RISK MANAGEMENT FILE IS STILL ACCURATE NO ADDITIONAL RISKS HAVE BEEN IDENTIFIED AND ADDITIONAL ACTIONS WILL NOT BE CONSIDERED. IF ADDITIONAL INFORMATION BECOME AVAILABLE THIS COMPLAINT FILE WILL BE RE-OPENED AND UPDATED ACCORDINGLY. DATE OF PUBLICATION OF ARTICLE THE CONTEMPORARY ROLE OF STENTS AND ANGIOPLASTY FOR THE TREATMENT OF INFRAPOPLITEAL DISEASE IN CRITICAL LIMB ISCHEMIA TAREK A. HAMMAD, ANAND PRASAD INTERVENTIONAL CARDIOLOGY 2017 ISSUE 58 DOI 10.1007/S11886-017-0871-9. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS PURPOSE OF THIS REVIEW IS TO HIGHLIGHT THE CONTEMPORARY ROLE OF STENTS AND ANGIOPLASTY FOR THE TREATMENT OF INFRAPOPLITEAL DISEASE IN CRITICAL LIMB ISCHEMIA. IT HAS BEEN PREVIOUSLY REPORTED THAT 25% OF PATIENTS WITH CRITICAL LIMB ISCHEMIA (CLI) WILL DIE AND 30% WILL UNDERGO A MAJOR AMPUTATION WITHIN ONE YEAR OF DIAGNOSIS. THIS REVIEW HIGHLIGHTS THE DEBATE-BTK TRIAL ¿ A RANDOMIZED TRIAL COMPRISING OF 158 DIABETICS WITH DE NOVO LESIONS INCLUDING 78% CTOS BELOW-THE-KNEE AND AIMED TO COMPARE THE IN.PACT AMPHIRION DCB WITH CONVENTIONAL PTA (1:1 RANDOMIZATION). THE MEAN LESION LENGTH IS REPORTED AS 130MM. AT 1 YEAR FOLLOW-UP THE DCB GROUP HAD A LOWER RATE OF BINARY RESTENOSIS (27 VS. 74%, RESPECTIVELY; P <(><<)> 0.001) AND TLR (18 VS. 43%, RESPECTIVELY; P = 0.01). THERE WAS NO INCREASE IN AMPUTATIONS NOTED IN THE DCB ARM. ALSO REVIEWED IS THE IN.PACT DEEP TRIAL WHICH AIMED TO EVALUATE DCB THERAPY WITH CONVENTIONAL PTA IN CLI 358 PATIENTS. THE MEAN LESION LENGTH IN THIS TRIAL WAS 116MM. IT IS REPORTED THAT THERE WAS NO DIFFERENCE BETWEEN DCB AND PTA IN THE PRIMARY EFFICACY ENDPOINT (DCB VS. PTA, RESPECTIVELY: CD-TLR OF 9.2 VS. 13.1%, P = 0.291) AND LATE LUMEN LOSS (LLL) OF 0.61 ± 0.78 MM VS. 0.62 ± 0.78 MM (P = 0.950). MAJOR AMPUTATION-FREE SURVIVAL AT 12 MONTHS WAS 81.1 AND 89.2% (P = 0.057), RESPECTIVELY, IN THE DCB AND PTA ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581295 IN.PACT ADMIRAL DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Other