BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 9304943 · Received November 11, 2019

    Report

    Report Number
    2134265-2019-13582
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    October 21, 2019
    Report Date
    February 7, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    PMA / PMN Number
    P180011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: (B)(6). PATIENT BIRTH DATE: (B)(6) 1953.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE 6X120MM ELUVIA STENT ON (B)(6) 2017 AS PART OF THE EMINENT CLINICAL STUDY. THE TARGET LESION WAS LOCATED IN THE MIDDLE SUPERFICIAL FEMORAL ARTERY (SFA) OF THE RIGHT LEG. THE TARGET LESION HAD A 5MM AND 5MM REFERENCE VESSEL DIAMETER, PROXIMALLY AND DISTALLY RESPECTIVELY, AND A TOTAL LENGTH OF 100MM VISUALLY ESTIMATED. THE TARGET LESION WAS 85% OCCLUDED AND CROSSED THROUGH THE TRUE LUMEN. PRE-DILATION WAS PERFORMED USING ONE BALLOON AND THE ELUVIA STUDY STENT WAS IMPLANTED. POST-DILATION WAS PERFORMED USING A BALLOON, AND 20% RESIDUAL STENOSIS REMAINED. NO THROMBUS WAS SEEN AT THE END OF THE PROCEDURE. ON (B)(6) 2019 IN-STENT STENOSIS WAS OBSERVED IN THE RIGHT LIMB. NO TREATMENT WAS PERFORMED UP TO DATE. THE EVENT IS CURRENTLY REPORTED AS ONGOING. IT WAS FURTHER REPORTED THAT ON (B)(6) 2020, 824 DAYS POST-INDEX PROCEDURE, THE 100% OCCLUSION OF THE RIGHT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY WITH 5MM REFERENCE VESSEL DIAMETER AND 120MM LENGTH WAS TREATED WITH THROMBOLYSIS. ON (B)(6) 2020, 825 DAYS POST-INDEX PROCEDURE, THE RIGHT MID TO DISTAL SFA WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). FINAL RESIDUAL STENOSIS WAS 5%. ON (B)(6) 2020 THE WAS CONSIDERED RESOLVED. ON (B)(6) 2020, THE SUBJECT WAS DISCHARGED.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). PATIENT BIRTH DATE: UNK/(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE 6X120MM ELUVIA STENT ON (B)(6) 2017 AS PART OF THE (B)(6) CLINICAL STUDY. THE TARGET LESION WAS LOCATED IN THE MIDDLE SUPERFICIAL FEMORAL ARTERY (SFA) OF THE RIGHT LEG. THE TARGET LESION HAD A 5MM AND 5MM REFERENCE VESSEL DIAMETER, PROXIMALLY AND DISTALLY RESPECTIVELY, AND A TOTAL LENGTH OF 100MM VISUALLY ESTIMATED. THE TARGET LESION WAS 85% OCCLUDED AND CROSSED THROUGH THE TRUE LUMEN. PRE-DILATION WAS PERFORMED USING ONE BALLOON AND THE ELUVIA STUDY STENT WAS IMPLANTED. POST-DILATION WAS PERFORMED USING A BALLOON, AND 20% RESIDUAL STENOSIS REMAINED. NO THROMBUS WAS SEEN AT THE END OF THE PROCEDURE. ON (B)(6) 2019 IN-STENT STENOSIS WAS OBSERVED IN THE RIGHT LIMB. NO TREATMENT WAS PERFORMED UP TO DATE. THE EVENT IS CURRENTLY REPORTED AS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099523 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0020519929

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O| R