BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA? VASCULAR

    MDR report key: 21632499 · Received March 18, 2025

    Report

    Report Number
    2124215-2025-16641
    Event Type
    Injury
    Date Received
    March 18, 2025
    Date of Event
    February 19, 2025
    Report Date
    April 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIP
    UDI-DI
    08714729873822
    PMA / PMN Number
    P140028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET / 510(K) #: K133110, P090003.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION REPORT IS BEING FILED TO UPDATE D4 (LOT NUMBER).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED, REQUIRING PLACEMENT OF ANOTHER STENT. THE OVER 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. AN 8.0X30X75CM EXPRESS LD STENT WAS USED FOR TREATMENT. HOWEVER, AFTER DEPLOYMENT, AN ANGIOGRAM SHOWED THAT THE DISTAL END OF THE STENT WAS UNRAVELED AND APPEARED TO FELL APART. AS A RESULT, AN EXPRESS LD 8X20X135 WAS DEPLOYED TO COVER THE PORTION OF THE PREVIOUS STENT. THE CATHETER WAS REMOVED WITH NO ISSUES, AND THE PROCEDURE WAS COMPLETED. THE PATIENT IS EXPECTED TO FULLY RECOVER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED, REQUIRING PLACEMENT OF ANOTHER STENT. THE OVER 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED COMMON ILIAC ARTERY. AN 8.0X30X75CM EXPRESS LD STENT WAS USED FOR TREATMENT. HOWEVER, AFTER DEPLOYMENT, AN ANGIOGRAM SHOWED THAT THE DISTAL END OF THE STENT WAS UNRAVELED AND APPEARED TO FELL APART. AS A RESULT, AN EXPRESS LD 8X20X135 WAS DEPLOYED TO COVER THE PORTION OF THE PREVIOUS STENT. THE CATHETER WAS REMOVED WITH NO ISSUES, AND THE PROCEDURE WAS COMPLETED. THE PATIENT IS EXPECTED TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT AN INNOVA SELF-EXPANDING STENT WAS USED, AND NOT AN EXPRESS LD STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306083 INNOVA? VASCULAR STENT, SUPERFICIAL FEMORAL ARTERY NIP BOSTON SCIENTIFIC CORPORATION H74939293086070 0035476288 08714729873822

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention