BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 6662708 · Received June 23, 2017

    Report

    Report Number
    9612164-2017-00802
    Event Type
    Injury
    Date Received
    June 23, 2017
    Date of Event
    January 1, 2016
    Report Date
    May 26, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE: NEW ENDOVASCULAR TECHNIQUES FOR TREATMENT OF LIFE-THREATENING TAKAYASU ARTERITIS ADVANCES IN INTERVENTIONAL CARDIOLOGY 2016; 12, 2 (44) MAREK KAZIBUDZKI1, LUKASZ TEKIELI1, MARIUSZ TRYSTULA1, PIOTR PALUSZEK1, ZBIGNIEW MOCZULSKI2, PIOTR PIENIAZEK1 1DEPARTMENT OF VASCULAR SURGERY AND ENDOVASCULAR INTERVENTIONS, JOHN PAUL II HOSPITAL, KRAKOW, POLAND 2CENTRE FOR DIAGNOSIS, PREVENTION AND TELEMEDICINE, JOHN PAUL II HOSPITAL, KRAKOW, POLAND ADV INTERV CARDIOL 2016; 12, 2 (44): 171¿174 DOI: 10.5114/AIC.2016.59369 FDC 24: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE - IN.PACT ADMIRAL IS CONTRAINDICATED FOR USE IN: CORONARY ARTERIES AND SUPRA -AORTIC/CEREBROVASCULAR ARTERIES. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A PATIENT WHO WAS PREVIOUSLY DIAGNOSED ON THE RHEUMATOLOGY WARD DUE TO UNEXPLAINED WEIGHT LOSS, ANAEMIA AND HIGHLY ELEVATED SYSTEMIC INFLAMMATION MARKERS. THESE FINDINGS WERE ACCOMPANIED BY SEVERE DIZZINESS AND AN EXTREMELY LOW VALUE OF SYSTEMIC BLOOD PRESSURE MEASURED ON BOTH ARMS. DOPPLER ULTRASOUND EXAMINATION FOLLOWED BY COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED THICKENING OF THE DESCENDING AORTA WALL, NEAR-TO-OCCLUSION STENOSIS OF BOTH COMMON CAROTID ARTERIES (CCA), SEVERE STENOSIS OF THE RIGHT SUBCLAVIAN ARTERY (RSA) AND OCCLUSION OF THE LEFT SUBCLAVIAN ARTERY (LSA) AS WELL AS THE RIGHT AXILLARY ARTERY. ACCORDING TO THE CRITERIA OF LARGE VESSEL VASCULITIS A DIAGNOSIS OF TA WAS MADE AND THE PATIENT WAS INITIATED ON A COMBINATION THERAPY OF CYCLOPHOSPHAMIDE, PREDNISOLONE AND HYDROCORTISONE. WITHIN THE NEXT 6 MONTHS, SHE WAS HOSPITALIZED SEVERAL TIMES DUE TO PERSISTENT NEUROLOGICAL SYMPTOMS INCLUDING DIZZINESS AND DROP ATTACKS. CLINICAL DETERIORATION WITH INCREASED NEUROLOGICAL SYMPTOMS OCCURRED. THE PATIENT WAS UNABLE TO ADOPT AN UPRIGHT POSITION BECAUSE OF SEVERE DIZZINESS; MOREOVER, RIGHT-HEMISPHERE TIA OCCURRED. SHE WAS ADMITTED TO OUR VASCULAR SURGERY DEPARTMENT IN (B)(6) 2015. AFTER COMPLEX NON-INVASIVE DIAGNOSTIC EVALUATION AND MULTIDISCIPLINARY TEAM (NEUROLOGIST, VASCULAR SURGEON, CARDIOLOGIST, ANGIOLOGIST) CONSULTATION SHE WAS SCHEDULED FOR INVASIVE AORTIC ARCH ANGIOGRAPHY IN TERMS OF ENDOVASCULAR TREATMENT VIA RIGHT FEMORAL ACCESS. A 6 FR DIAGNOSTICS PIGTAIL CATHETER WAS INTRODUCED. ANGIOGRAPHY REVEALED: OCCLUSION OF THE LSA, OCCLUSION OF THE LEFT CCA, SIGNIFICANT NARROWING OF THE INNOMINATE ARTERY (IA), LONG, 95% STENOSIS OF RIGHT CCA, AND 80% STENOSIS OF THE RSA. FILTERWIRE EZ, A DISTAL NEURO PROTECTION DEVICE, WAS INTRODUCED AND OPENED IN THE RIGHT ICA. TWO INFLATIONS AT 6 ATM/60 S USING A 5.0 × 60 MM IN PACT ADMIRAL DRUG ELUTING BALLOON WERE PERFORMED IN THE RIGHT CCA COVERING THE WHOLE STENOTIC SEGMENT. IN SPITE OF LONG INFLATIONS THE PATIENT COMPLAINED ONLY OF TEMPORARY INFLATION-RELATED RIGHT-SIDE NECK PAIN. AS SIGNIFICANT DISSECTION OF THE PROXIMAL AND MIDDLE PART OF THE RIGHT CCA (RCCA) OCCURRED, TWO SELF-EXPANDABLE STENTS - PRECISE PRO 8.0 × 40 MM -DISTALLY, 9.0 × 30 MM PROXIMALLY; WERE IMPLANTED, COVERING THE DISSECTED SEGMENT AS WELL AS THE ARTERY OSTIUM AND BIFURCATION WITH THE RSA. POST DILATATION WITH A 5.0 × 20 MM BALLOON CATHETER (2 × 12 ATM/20 S) WAS DONE. THE NEXT TARGET WAS THE RSA. STENT STRUTS COVERING THE RSA OSTIUM WERE CROSSED WITH A 0.014 IN HT BMW 0.014 IN WIRE AND THEN PREDILATED WITH A 2.0 × 20 MM BALLOON CATHETER. A CORONARY, DRUG-ELUTING STENT - XIENCE PRO 4.0 × 23 MM - WAS IMPLANTED AT 18 ATM/30 S AND POST-DILATED WITH A 5.0 × 20 MM BALLOON CATHETER AT 14 ATM/40 S. A FILTER FROM THE RICA WAS RETRIEVED VERY EASILY. IN CONTROL ANGIOGRAPHY CORRECT LOCATION OF STENTS WITH NO RESIDUAL STENOSIS AND SIGNIFICANT BLOOD FLOW IMPROVEMENT TO BOTH HEMISPHERES WERE RECORDED. WITHIN THE NEXT 12 H SIGNIFICANT IMPROVEMENT OF GENERAL STATUS AND REDUCTION OF NEUROLOGICAL SYMPTOMS WERE OBSERVED. THE PATIENT WAS DISCHARGED AFTER 4 DAYS OF HOSPITALIZATION ON DUAL ANTIPLATELET THERAPY. CONTROL DUS PERFORMED 4 WEEKS LATER DEMONSTRATED GOOD FLOW THROUGH IMPLANTED STENTS WITH NO SIGNS OF RESTENOSIS. THREE AND 8 MONTHS AFTER THE PROCEDURE, CONTROL ANGIO-CT REVEALED PATENCY OF ALL STENTS AND NO NEW STENOTIC LESIONS OF TREATED VESSELS. UP TO NOW, THE PATIENT HAS REMAINED IN GOOD CLINICAL STATUS WITHOUT ANY NEUROLOGICAL DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445250 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention