BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 8281507 · Received January 28, 2019

    Report

    Report Number
    2134265-2019-00415
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    November 6, 2018
    Report Date
    April 1, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    PMA / PMN Number
    P180011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN STENT RESTENOSIS OCCURRED. THE PATIENT WAS ENROLLED IN THE IMPERIAL CLINICAL STUDY ON (B)(6) 2016, AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 98% STENOSED. THE TARGET LESION WAS 30MM LONG, WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5.00MM, AND A DISTAL REFERENCE DIAMETER OF 6.00MM; AND WAS CLASSIFIED AS A TASC II A LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, AND A 7MM X 40MM ELUVIA STENT WAS PLACED. RESIDUAL STENOSIS WAS 5%. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2018, THE PATIENT WAS NOTED TO HAVE INTRASTENT STENOSIS IN THE LEFT DISTAL SFA. ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION. ON (B)(6) 2019, 80% IN STENT RESTENOSIS WAS NOTED IN THE LEFT DISTAL SFA. THE LESION WAS TREATED WITH DRUG COATED BALLOON ANGIOPLASTY, AND RESIDUAL STENOSIS WAS 5%. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY. FURTHER INFORMATION RECEIVED REPORTED THAT ON JANUARY 21ST, 2019, 70% IN-STENT RESTENOSIS WAS FOUND (ISR) AT THE PROXIMAL END OF THE SHORT STENT IN THE ADDUCTOR CANAL AND PREVIOUSLY DOCUMENTED OCCLUSION FOUND IN THE ANTERIOR TIBIAL ARTERY. THE COMMON AND DEEP FEMORAL ARTERIES, AS WELL AS THE SFA WERE PATENT. THE POSTERIOR TIBIAL ARTERY UP TO THE FOOT, AS WELL AS THE DORSALIS PEDIS WERE PATENT. THE ISR WAS TREATED WITH DRUG COATED BALLOON ANGIOPLASTY AND A 6MMX4CM IMPACT STENT. THERE WAS 5% RESIDUAL STENOSIS FOLLOWING TREATMENT. FOLLOW-UP CORE-LAB ANGIOGRAPHY FINDING DATED JANUARY 21ST, 2019, NOTED THROMBUS OF GRADE 0 AND ABSENCE OF ANEURYSM. HOWEVER, CORE LAB NOTED THE PRESENCE OF ISR PATTERN 1B.

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN STENT RESTENOSIS OCCURRED. THE PATIENT WAS ENROLLED IN THE (B)(6) CLINICAL STUDY ON (B)(6) 2016, AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 98% STENOSED. THE TARGET LESION WAS 30MM LONG, WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5.00MM, AND A DISTAL REFERENCE DIAMETER OF 6.00MM; AND WAS CLASSIFIED AS A TASC II A LESION. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, AND A 7MM X 40MM ELUVIA STENT WAS PLACED. RESIDUAL STENOSIS WAS 5%. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2018, THE PATIENT WAS NOTED TO HAVE INTRASTENT STENOSIS IN THE LEFT DISTAL SFA. ON (B)(6) 2019, THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION. ON (B)(6) 2019, 80% IN STENT RESTENOSIS WAS NOTED IN THE LEFT DISTAL SFA. THE LESION WAS TREATED WITH DRUG COATED BALLOON ANGIOPLASTY, AND RESIDUAL STENOSIS WAS 5%. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75440 ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24620 0018747587

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention