BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 14091681 · Received April 13, 2022

    Report

    Report Number
    2134265-2022-04236
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 18, 2022
    Report Date
    May 27, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    PMA / PMN Number
    P180011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6). ANALYSIS BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF AN ELUVIA SELF-EXPANDING STENT SYSTEM. THE OUTER SHEATH, TIP, INNER SHEATH, AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. VISUAL EXAMINATION THE ELUVIA WAS RETURNED IN SEVERAL PIECES AS THE HANDLE HAD BEEN BROKEN OPEN AND THE WHEEL HAD SEPARATED FROM THE HANDLE. THE STENT WAS NOT RETURNED. MICROSCOPIC EXAMINATION FOUND A KINK 4 MM FROM THE NOSECONE AND ANOTHER KINK 11.6 CM FROM THE NOSECONE. BECAUSE THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES, IT WAS CONSIDERED LIKELY THAT THE KINKS WERE ATTRIBUTABLE TO HANDLING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 7X120X130CM ELUVIA SELF-EXPANDING STENT WAS SELECTED FOR USE. TREATMENT OF THE TOTAL OCCLUSION WAS DONE USING A CONTRALATERAL APPROACH BECAUSE IPSILATERAL PUNCTURE WAS NOT POSSIBLE. THE PATIENT HAD A HISTORY OF ENDOVASCULAR THERAPY FOR ILIAC DISEASE, SO THREE STENTS HAD ALREADY BEEN PLACED. BECAUSE OF THIS, AND DUE TO THE SEVERE TORTUOSITY, IT WAS DECIDED THAT THE GUIDE CATHETER COULD NOT BE ADVANCED ALONE. FOLLOWING PRE-DILATION, AN ELUVIA WAS REQUESTED TO BE PLACED USING A .035 GUIDEWIRE IN ADVANCE, BUT A JUPITER WIRE WAS SELECTED "ACCIDENTALLY". AS THE STENT WAS BEING DEPLOYED, THE WIRE BECAME ENTRAPPED IN THE HANDLE AND PREVENTED THE STENT FROM BEING DEPLOYED HALFWAY THROUGH. THE PHYSICIAN BROKE THE HANDLE TO SUCCESSFULLY COMPLETE STENT DEPLOYMENT IN THE TARGET LOCATION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 7X120X130CM ELUVIA SELF-EXPANDING STENT WAS SELECTED FOR USE. TREATMENT OF THE TOTAL OCCLUSION WAS DONE USING A CONTRALATERAL APPROACH BECAUSE IPSILATERAL PUNCTURE WAS NOT POSSIBLE. THE PATIENT HAD A HISTORY OF ENDOVASCULAR THERAPY FOR ILIAC DISEASE, SO THREE STENTS HAD ALREADY BEEN PLACED. BECAUSE OF THIS, AND DUE TO THE SEVERE TORTUOSITY, IT WAS DECIDED THAT THE GUIDE CATHETER COULD NOT BE ADVANCED ALONE. FOLLOWING PRE-DILATION, AN ELUVIA WAS REQUESTED TO BE PLACED USING A .035 GUIDEWIRE IN ADVANCE, BUT A JUPITER WIRE WAS SELECTED "ACCIDENTALLY". AS THE STENT WAS BEING DEPLOYED, THE WIRE BECAME ENTRAPPED IN THE HANDLE AND PREVENTED THE STENT FROM BEING DEPLOYED HALFWAY THROUGH. THE PHYSICIAN BROKE THE HANDLE TO SUCCESSFULLY COMPLETE STENT DEPLOYMENT IN THE TARGET LOCATION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165258 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0028059665

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown