BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 6020925 · Received October 12, 2016

    Report

    Report Number
    9612164-2016-01081
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    November 24, 2015
    Report Date
    September 12, 2016
    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

    AGE: AVERAGE AGE OF PATIENTS IN THE STUDY. GENDER: MAJORITY NUMBER OF GENDER TOTAL IN THE STUDY. DATE OF EVENT: DATE OF EVENT IS THE DATE THE JOURNAL WAS PUBLISHED. JOURNAL TITLE: FEASIBILITY AND CLINICAL OUTCOMES OF PERIPHERAL DRUG-COATED BALLOON IN HIGH-RISK PATIENTS WITH FEMOROPOPLITEAL DISEASE PLOS ONE / DOI:10.1371/JOURNAL.PONE.0143658 NOVEMBER 24, 2015.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BACKGROUND CLINICAL OUTCOMES OF THE DRUG-COATED BALLOON (DCB) PROCEDURE IN HIGH-RISK PATIENTS WITH FEMOROPOPLITEAL (FP) DISEASE HAVE NOT BEEN INVESTIGATED SUFFICIENTLY. METHODS THIS RETROSPECTIVE, SINGLE-CENTER STUDY ANALYZED 87 PATIENTS (39% DIALYSIS) AND 97 AFFECTED LEGS (64% CRITICAL LIMB ISCHEMIA [CLI]) THAT UNDERWENT DCB FOR SYMPTOMATIC FP DISEASE FROM MARCH 2013 TO SEPTEMBER 2014. RISK STRATIFICATION WAS BASED ON FEDCLIP (FEMALE, DIABETES, DIALYSIS, CLI, LESION LENGTH >150 MM AND POOR RUNOFF) SCORE. THE DCB OUTCOMES AMONG THE DIFFERENT RISK GROUPS WERE COMPARED AND FACTORS PREDICTING RESTENOSIS WERE ANALYSED DURING FOLLOW-UP. RESULTS MOST OF STUDY PARTICIPANTS (84%) WERE MODERATE TO HIGH-RISK PATIENTS. THE PROCEDURAL SUCCESS RATE WAS 100% AND THE 30-DAY MAJOR ADVERSE VASCULAR EVENT RATE WAS 2.1%. THE MEAN LESION LENGTH WAS 178 ± 106 MM AND THE MEAN FOLLOW-UP TIME WAS 428 ± 145 (RANGE 50¿782) DAYS. THE BINARY RESTENOSIS-FREE AND CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (CD-TLR)-FREE RATES AT 12 MONTHS WERE 77.5% AND 84.3%, RESPECTIVELY, FOR ALL PARTICIPANTS. NO SIGNIFICANT DIFFERENCES WERE OBSERVED IN 1-YEAR BINARY RESTENOSIS AND CD-TLR RATES IN THE LOW-, MODERATE-, AND HIGH-RISK GROUPS (60%, 84%, AND 73%: P = 0.396; 78%, 89%, AND 80%: P = 0.635, RESPECTIVELY). IN MULTIVARIATE ANALYSIS, LESION LENGTH >150 MM (HAZARD RATIO [HR]: 8.00, 95% CONFIDENCE INTERVAL (CI) 1.12 TO 55.6, P = 0.038) AND RUTHERFORD CLASS 6 (HR: 7.09, 95% CI, 1.15 TO 43.5, P = 0.034) WERE IDENTIFIED AS INDEPENDENT PREDICTORS OF BINARY RESTENOSIS. CONCLUSIONS DESPITE GENERAL COMORBIDITIES AND ADVANCED LIMB ISCHEMIA, 1-YEAR OUTCOMES OF DCB IN HIGH-RISK PATIENTS WITH FP DISEASE WERE EFFECTIVE. THE DCB PROCEDURE HOLDS PROMISE TO IMPROVE VESSEL PATENCY; HOWEVER, LESION LENGTH >150 MM AND MAJOR TISSUE LOSS WERE INDEPENDENT PREDICTORS FOR BINARY RESTENOSIS AFTER THE TREATMENT. IN.PACT ADMIRAL DCBS (MEDTRONIC IRELAND, GALWAY, IRELAND) WERE USED EXCLUSIVELY IN THIS STUDY. THE 40 TO 150-MM LONG BALLOONS WERE COATED WITH PACLITAXEL AT A DOSE OF 3 G/MM2 OF THE BALLOON SURFACE IN A SPECIFIC SURFACE MATRIX COATING CONSISTING OF UREA (FREEPAC; MEDTRONIC IRELAND). SELF-EXPANDING NITINOL STENTS WERE IMPLANTED IN CASES WITH A SUBOPTIMAL ANGIOGRAPHIC RESULT OR FLOW-LIMITING DISSECTION, DETERMINED BY RESIDUAL STENOSIS > 50%, TRANS-LESION PRESSURE GRADIENT _ 20 MMHG, OR SIGNIFICANT CHANGE IN THE DOPPLER WAVEFORM SPECTRUM. SEVERAL ADJUVANT PROCEDURES USING VARIOUS DEVICES WERE PERFORMED TO OPTIMIZE THE LESIONS FOR THE USE OF DCB, INCLUDING 5 TURBOHAWK ATHERECTOMIES (EV3, IRVINE, CA, USA), 3 EXCIMER LASER ANGIOPLASTIES (SPECTRANETICS, COLORADO SPRINGS, CO, USA), 2 ROTATIONAL ATHERECTOMIES (BOSTON SCIENTIFIC, NATICK, MA, USA), 2 PERIPHERAL CUTTING BALLOONS (BOSTON SCIENTIFIC), 1 TRUEPATH (BOSTON SCIENTIFIC) AND 6 IVUSS (VISIONS1 PV CATHETER, VOLCANO THERAPEUTICS, RANCHO CORDOVA, CA, USA). PROVISIONAL STENTS WERE IMPLANTED IN 24 (30%) OF 81 NON-ISR LESIONS (MEAN STENT LENGTH 107 ± 59 MM) WITH EITHER FLOW-LIMITING DISSECTION OR A SUBOPTIMAL RESULT. ONE PATIENT RECEIVED URGENT PERCUTANEOUS CORONARY INTERVENTION DUE TO ACUTE MI AFTER EVT WHILE ANOTHER PATIENT UNDERWENT UNPLANNED REINTERVENTION BECAUSE OF SUBACUTE ARTERIAL OCCLUSION 1 WEEK AFTER THE INDEX PROCEDURE. IVUS REVEALED THAT INADEQUATE SUBINTIMAL SPACE WITHOUT BAILOUT STENTING RESULTED IN FLOW REDUCTION AND SUBSEQUENT ARTERIAL OCCLUSION. THE 30-DAY MAVE RATE WAS 2.1%. 7 PATIENTS DIED. CAUSES OF DEATH INCLUDED SEPSIS WITH MULTI-ORGAN FAILURE IN 6 PATIENTS AND 1 FATAL MI 202 DAYS FOLLOWING THE INDEX PROCEDURE. SIX MINOR AMPUTATIONS WERE PERFORMED TO ACHIEVE COMPLETE WOUND CLOSURE AND 1 MAJOR AMPUTATION WAS PERFORMED AT 399 DAYS AFTER DCB TREATMENT BECAUSE OF SEVERE WOUND INFECTION. ONE PATIENT SUFFERED FROM NONFATAL MI AND ANOTHER PATIENT HAD AN ISCHEMIC STROKE DURING THE FOLLOW-UP. THE LESIONS WERE TREATED WITH IN.PACT ADMIRAL PACLITAXEL ELUTING BALLOON CATHETER. DURING PROCEDURE FLOW-LIMITING DISSECTION OCCURRED AND WAS TREATED WITH STENTING. AT FOLLOW UP ADVERSE EVENTS REPORTED WERE OCCLUSION TREATED WITH REVASCULARIZATION, LIMB AMPUTATION OR EMERGENT SURGERY AND DEATHS. CAUSE OF DEATHS WAS SEPSIS, MULTIPLE ORGAN FAILURE AND MI. PRIOR TO PROCEDURE, PATIENTS WERE ON ASA AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672815 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention