BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA VASCULAR

    MDR report key: 8921100 · Received August 22, 2019

    Report

    Report Number
    2134265-2019-10093
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    July 8, 2019
    Report Date
    August 22, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIP
    PMA / PMN Number
    P140028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE PATIENT WAS ENROLLED INTO THE (B)(6) CLINICAL STUDY ON (B)(6) 2017 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. TARGET LESION #1 WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND HAD 75% STENOSIS. THE REFERENCE VESSEL DIAMETER WAS 5MM, HAD A LENGTH OF 70 MM AND WAS CLASSIFIED AS A TASC II A LESION. THE TARGET LESION WAS TREATED WIT PRE-DILATION USING A 4MM X 80MM BALLOON, FOLLOWED BY A 5MM X 80MM RANGER STUDY BALLOON. POST DILATION WAS NOT PERFORMED AND THE RESIDUAL STENOSIS WAS 5%. ON (B)(6) 2018, SELECTIVE LEFT LOWER EXTREMITY ARTERIOGRAPHY REVEALED PATENT COMMON AND EXTERNAL ILIAC ARTERIES, PATENT LEFT COMMON FEMORAL ARTERY AND PROFUNDA, DISTAL EMBOLIZATION OF PROFUNDA FEMORIS EMBOLI, RECURRENT 70% FOCAL PROXIMAL RE-STENOSIS STRETCHING 3-4 CM IN LENGTH IN THE PREVIOUSLY TREATED REGION DURING INDEX PROCEDURE AND THE SUBJECT WAS DIAGNOSED WITH RECURRENT STENOSIS IN PROXIMAL LEFT SFA. HENCE, ON (B)(6) 2018, 168 DAYS POST INDEX PROCEDURE, 70% STENOSIS IN PROXIMAL LEFT SFA WAS PRE-DILATED WITH 5 MM X 4 CM STERLING BALLOON. THE STENOSIS WAS TREATED WITH 6 CM X 6 CM INNOVA SELF-EXPANDING NITINOL STENT AND POST DILATED WITH 5 MM STERLING BALLOON. POST TREATMENT ANGIOGRAPHY REVEALED NO SIGNIFICANT RESIDUAL STENOSIS OR DISSECTION. ON (B)(6) -2019, 671 DAYS POST-INDEX PROCEDURE, ANGIOGRAPHY REVEALED 70% IN-STENT STENOSIS OF THE INNOVA STENT, ABOUT 3CM IN LENGTH IN THE PROXIMAL LEFT SFA. ANKLE BRACHIAL INDEX WAS SUGGESTIVE OF SEVERE ARTERIAL INSUFFICIENCY OF THE LEFT LOWER EXTREMITY. ON (B)(6) 2019, REVASCULARIZATION WAS PERFORMED USING A NON-BSC DRUG-COATED BALLOON WITH LESS THAN 20% RESIDUAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715399 INNOVA VASCULAR STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention