BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA SELF-EXPANDING STENT SYSTEM

    MDR report key: 7253660 · Received February 8, 2018

    Report

    Report Number
    2134265-2018-00622
    Event Type
    Injury
    Date Received
    February 8, 2018
    Report Date
    January 16, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIP
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KOROSOGLOU G, ET AL. (CARDIOLOGY AND VASCULAR MEDICINE, GRN ACADEMIC TEACHING HOSPITAL, ROENTGENSTRASSE 1, WEINHEIM, 69469, GERMANY.) WORLD JOURNAL OF CARDIOLOGY 2017: 9(12) P.842-847. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT STENT OCCLUSION AND PATIENT STENOSIS OCCURRED. THE PATIENT HAD HISTORY OF MULTI-VESSEL CORONARY ARTERY DISEASE WITH NON-ST ELEVATION MYOCARDIAL INFARCTION 3 MO AGO. LEFT VENTRICULAR FUNCTION WAS MODERATELY REDUCED. IN ADDITION, SHE HAD HISTORY OF ARTERIAL HYPERTENSION, HYPERLIPIDEMIA, PRIOR CIGARETTE SMOKING AND TYPE 2 DIABETES MELLITUS. FURTHERMORE, ATRIAL FIBRILLATION WAS PRESENT. THE PATIENT HAD HISTORY OF LEFT FEMORAL POPLITEAL BYPASS SURGERY AS WELL AS FEMORAL THROMBOENDARTERECTOMY AND PATCH ANGIOPLASTY SURGERY 2 YEARS AGO. THE PATIENT ALSO HAD A HISTORY OF CHRONIC RENAL DISEASE, ATRIAL FIBRILLATION, CHRONIC OBSTRUCTIVE LUNG DISEASE (GOLD CLASS 3), TYPE 2 DIABETES MELLITUS AND MULTIVESSEL CORONARY ARTERY DISEASE WITH PRIOR NON-ST ELEVATION INFARCTION 3 MO AGO. THE PATIENT HAD A HISTORY OF FAILED BYPASS SURGERY AND SEVERE CARDIO-PULMONARY COMORBIDITIES THE PATIENT WAS SCHEDULED FOR INVASIVE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). A 6F GUIDING CROSS-OVER INTRODUCER SHEATH (NON-BSC) WAS INSERTED IN THE LEFT SFA. SUBSEQUENTLY, 500 MG ASPIRIN AND 5000 IU OF HEPARIN WAS INJECTED AND ANTEGRADE RECANALIZATION WAS ATTEMPTED USING DIFFERENT HYDROPHILIC TAPERED AND NON-TAPERED GUIDEWIRES. HOWEVER, ANTEGRADE CROSSING OF THE OCCLUSION FAILED. A STENT WAS IDENTIFIED AT THE LEVEL OF THE MID SFA, WHICH WAS SUBSEQUENTLY DIRECTLY PUNCTURED, FACILITATING THE RETROGRADE INSERTION OF A 0.035¿¿ GUIDEWIRE (NON-BSC) SUBSEQUENTLY, RETROGRADE PASSAGE OF A 0.018¿¿ GUIDEWIRE (NON-BSC) WAS ACHIEVED OVER A 0.035¿¿ SUPPORT CATHETER (NON-BSC), WHICH WAS THEN SNARED IN THE 6F GUIDING CROSS-OVER SHEATH. THEN, THE RETROGRADE 0.035¿¿ SUPPORT CATHETER WAS PULLED BACK AND A SECOND ANTEGRADE 0.035¿¿ SUPPORT CATHETER WAS INSERTED OVER THE 6F GUIDING CROSS-OVER SHEATH, WHICH PASSED OVER THE SFA THROUGH THE PUNCTURED STENT AND WAS ADVANCED TO THE LEVEL OF THE POPLITEAL ARTERY. OVER THIS 0.035¿¿ SUPPORT CATHETER, A 0.014¿¿ GUIDEWIRE (NON-BSC) WAS ADVANCED TO THE PROXIMAL ANTERIOR TIBIAL ARTERY AND ITS INTRALUMINAL LOCALIZATION WAS CONFIRMED BY DSA. BALLOON ANGIOPLASTY WAS THEN PERFORMED USING A 2.5 MM × 200 MM BALLOON (NON-BSC) IN THE INFRAPOPLITEAL LEVEL AND 5.0 MM × 200 MM AND 6.0 MM × 200 MM BALLOONS (NON-BSC) IN THE POPLITEAL AND SFA, RESPECTIVELY. DUE TO EXTENSIVE DISSECTION OF THE PROXIMAL SFA A 6.0MM × 80 MM INNOVA SELF-EXPANDING BARE METAL STENT WAS PLACED. THE FINAL ANGIOGRAPHIC RESULT WAS JUDGED AS SUBOPTIMAL DUE TO THE ABSENCE OF OUTFLOW IN THE LOWER LEG. HOWEVER, INTERVENTION WAS STOPPED AT THIS POINT DUE TO CONTRAST AGENT ADMINISTRATION OF APPROXIMATELY 200 ML WITH CHRONIC RENAL DISEASE. THE PATIENT WAS PUT ON TREATMENT WITH 100 MG ASPIRIN, 75 MG CLOPIDOGREL AND 5 MG FONDAPARINUX DAILY AND WAS SCHEDULED FOR RE-ANGIOGRAPHY AFTER 4 WEEKS. IN THE SECOND SESSION ANTEGRADE PUNCTURE OF THE LEFT CFA WAS PERFORMED DIRECTLY ABOVE THE IMPLANTED STENT IN THE PROXIMAL SFA WITH SUBSEQUENT INSERTION OF A SHORT 6F GUIDING INTRODUCER SHEATH. DSA REVEALED MODERATE RESTENOSIS OF THE MID SFA AND OF THE POPLITEAL ARTERY, WHICH WERE TREATED USING 5.0 MM × 120 MM AND 6.0 MM × 120 MM DRUG COATED BALLOONS (NON-BSC), RESPECTIVELY. IN ADDITION, RECANALIZATION OF THE FIBULAR ARTERY WAS PERFORMED, RESULTING IN FUNCTIONAL 2 VESSELS OUT-FLOW OF THE SHORTLY OCCLUDED POSTERIOR TIBIAL AND OF THE FIBULAR ARTERY TO THE LEFT FOOT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND WAS SET ON TREATMENT WITH 5 MG RAMIPRIL, 20 MG ATORVASTATIN, 5 MG BISOPROLOL, 75 MG CLOPIDOGREL AND 15 MG RIVAROXABAN PER DAY. AFTER 8 WEEKS, DUPLEX SONOGRAPHY EXHIBITED A WELL PERFUSED SFA WITH BIPHASIC FLOW IN THE DISTAL SFA AND IN THE POPLITEAL ARTERY AND MONOPHASIC FLOW OF THE DISTAL FIBULAR AND POSTERIOR TIBIAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98604 INNOVA SELF-EXPANDING STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC - MAPLE GROVE UNK695

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention