BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA

    MDR report key: 11474383 · Received March 12, 2021

    Report

    Report Number
    2134265-2021-03154
    Event Type
    Injury
    Date Received
    March 12, 2021
    Date of Event
    October 15, 2020
    Report Date
    November 8, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: (B)(6). E1: INITIAL REPORTER ADDRESS: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE EMINENT CLINICAL STUDY ON (B)(6) 2019. THE INDEX PROCEDURE WAS PERFORMED THE SAME DAY. A 6MM X 120MM X 130CM INNOVA STENT WAS SELECTED FOR USE WITHIN THE RIGHT PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS 95% STENOSED AND WAS 100 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6 MM AND WAS CLASSIFIED AS TASC II B LESION. DURING THE PROCEDURE, THE TARGET LESION WAS TREATED WITH PRE-DILATION, FOLLOWED BY PLACEMENT OF THE INNOVA STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 10%. ON OCTOBER 18, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2020, 364 DAYS POST-INDEX PROCEDURE, SUBJECT VISITED THE SITE FOR PROTOCOL SCHEDULED 12-MONTH FOLLOW-UP VISIT WITH MODERATE PROBLEMS IN WALKING AND SYMPTOMS OF CLAUDICATION IN RIGHT LEG. DUPLEX ULTRASOUND SCAN REVEALED IN-STENT RESTENOSIS. NO ACTION WAS TAKEN TREAT THE EVENT. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE EVENT WAS CONSIDERED TO BE RECOVERED / RESOLVED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). INITIAL REPORTER ADDRESS: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT WAS ENROLLED IN THE (B)(6) CLINICAL STUDY ON (B)(6) 2019. THE INDEX PROCEDURE WAS PERFORMED THE SAME DAY. A 6MM X 120MM X 130CM INNOVA STENT WAS SELECTED FOR USE WITHIN THE RIGHT PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS 95% STENOSED AND WAS 100 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 6 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6 MM AND WAS CLASSIFIED AS TASC II B LESION. DURING THE PROCEDURE, THE TARGET LESION WAS TREATED WITH PRE-DILATION, FOLLOWED BY PLACEMENT OF THE INNOVA STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 10%. ON (B)(6), THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2020, 364 DAYS POST-INDEX PROCEDURE, SUBJECT VISITED THE SITE FOR PROTOCOL SCHEDULED 12-MONTH FOLLOW-UP VISIT WITH MODERATE PROBLEMS IN WALKING AND SYMPTOMS OF CLAUDICATION IN RIGHT LEG. DUPLEX ULTRASOUND SCAN REVEALED IN-STENT RESTENOSIS. NO ACTION WAS TAKEN TREAT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369039 INNOVA STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC CORPORATION 26920 0023894335

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other