BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 13010230 · Received December 15, 2021

    Report

    Report Number
    2134265-2021-15396
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    October 4, 2021
    Report Date
    February 2, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UPDATED FROM (B)(6) 2021 TO (B)(6) 2021. PATIENT IDENTIFIER: (B)(6). INITIAL REPORTER FACILITY NAME: (B)(6). INITIAL REPORTER ADDRESS 1: (B)(6).

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: (B)(6). INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    EMINENT CLINICAL STUDY. IT WAS REPORTED THERE WAS IN-STENT STENOSIS. THE SUBJECT WAS ENROLLED IN THE EMINENT STUDY ON (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN RIGHT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS AND WAS 50 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 4.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4.7 MM AND WAS CLASSIFIED AS TASC II A LESION. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 6 MM X 80 MM STUDY STENT. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2021, 963 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED DUE TO CLAUDICATION SYMPTOMS, WHICH HAVE BECOME MORE INTENSE IN THE LAST FEW WEEKS. ABI WAS AT DORSALIS PEDIS ARTERY WAS 0.58 AND POSTERIOR TIBIAL ARTERY WAS AT 0.60. ON (B)(6) 2021, COMPUTED TOMOGRAPHY (CT) SCAN REVEALED SEVERE STENOSIS OF RIGHT PROXIMAL SFA AND SEVERE CALCIFIED PLAQUE STENOSIS AT THE JUNCTION OF THE P2 TO THE P3 SEGMENT OF THE RIGHT POPLITEAL ARTERY, MAINTAINING THREE-VESSEL SUPPLY TO THE RIGHT LOWER LEG. ON (B)(6) 2021, 1012 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH UNKNOWN SYMPTOMS. ON THE SAME DAY, THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON THE SAME DAY, THE ANGIOGRAPHY WAS PERFORMED, AND IT REVEALED EVIDENCE OF SEVERE STENOSIS OF PROXIMAL SFA, IN THE STENT REGION OF MID SFA AND SEGMENT II OF THE POPLITEAL ARTERY. THE SUBJECT WAS DIAGNOSED WITH STAGE IIB PERIPHERAL ARTERY OCCLUSIVE DISEASE (PAOD) ON THE RIGHT ASSOCIATED WITH SUSPECTED IN STENT STENOSIS (ISR) ON THE RIGHT IN SFA INVOLVING POPLITEAL ARTERY. ON (B)(6) 2021, 1012 DAYS POST INDEX PROCEDURE, THE 60% STENOSIS PROXIMAL TO MID SFA WITH LESION LENGTH 120 MM AND REFERENCE VESSEL DIAMETER OF 5 MM WAS TREATED WITH 6 MM NON-BOSTON SCIENTIFIC EMBOLIC PROTECTION SYSTEM IS INSERTED AND ATHERECTOMY WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC 6F DIRECTIONAL ATHERECTOMY SYSTEM TO THE AFOREMENTIONED LESIONS WITH MULTIPLE PASSAGES OF THE STENOSIS, EXTRACTION OF SOFT AND HARD PLAQUE DURING THIS. SUBSEQUENT DRUG ELUTING BALLOON ANGIOPLASTY OF THE ATHERECTOMY WITH LESIONS OF THE POPLITEAL ARTERY IN SEGMENT II, ADJACENT TO THE STENT AS WELL AS ISR AND OF THE PROXIMAL SFA WITH NON-BOSTON SCIENTIFIC DRUG ELUTING BALLOONS 4 MM X 40 MM, 5 MM X 21 MM AND 5 MM X40 MM. WHEN REMOVING THE NON-BOSTON SCIENTIFIC EMBOLIC PROTECTION SYSTEM, EMBOLI ARE EXTRICATED. POST-TREATMENT, NO EVIDENCE OF ANY REMAINING STENOSES IN THE FINAL ANGIOGRAPHY AND IMPROVED HEMODYNAMICS AT THE LOWER LEG AND NO PERIPHERAL COMPLICATIONS NOTED, RESULTING INTO 10% RESIDUAL STENOSIS. THE SUBJECT WAS RECOMMENDED CONTINUING ASA 100 MG/DAY AS PERMANENT THERAPY AND CLOPIDOGREL 75 MG/DAY FOR 12 WEEKS AS WELL, ALONG WITH THROMBOLYSIS PROPHYLAXIS FOR 24 HOURS. ON (B)(6) 2021, THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED. ON (B)(6) 2021, ABI WAS AT DORSALIS PEDIS ARTERY WAS 0.97 AND POSTERIOR TIBIAL ARTERY WAS AT 1.02. ON (B)(6) 2011, THE SUBJECT WAS DISCHARGED.

    Description of Event or Problem · 0

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THERE WAS IN-STENT STENOSIS. THE SUBJECT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN RIGHT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS AND WAS 50 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 4.5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 4.7 MM AND WAS CLASSIFIED AS TASC II A LESION. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 6 MM X 80 MM STUDY STENT. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2021, 963 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED DUE TO CLAUDICATION SYMPTOMS, WHICH HAVE BECOME MORE INTENSE IN THE LAST FEW WEEKS. ABI WAS AT DORSALIS PEDIS ARTERY WAS 0.58 AND POSTERIOR TIBIAL ARTERY WAS AT 0.60. ON (B)(6) 2021, COMPUTED TOMOGRAPHY (CT) SCAN REVEALED SEVERE STENOSIS OF RIGHT PROXIMAL SFA AND SEVERE CALCIFIED PLAQUE STENOSIS AT THE JUNCTION OF THE P2 TO THE P3 SEGMENT OF THE RIGHT POPLITEAL ARTERY, MAINTAINING THREE-VESSEL SUPPLY TO THE RIGHT LOWER LEG. ON (B)(6) 2021, 1012 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH UNKNOWN SYMPTOMS. ON THE SAME DAY, THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. ON THE SAME DAY, THE ANGIOGRAPHY WAS PERFORMED, AND IT REVEALED EVIDENCE OF SEVERE STENOSIS OF PROXIMAL SFA, IN THE STENT REGION OF MID SFA AND SEGMENT II OF THE POPLITEAL ARTERY. THE SUBJECT WAS DIAGNOSED WITH STAGE IIB PERIPHERAL ARTERY OCCLUSIVE DISEASE (PAOD) ON THE RIGHT ASSOCIATED WITH SUSPECTED IN STENT STENOSIS (ISR) ON THE RIGHT IN SFA INVOLVING POPLITEAL ARTERY. ON (B)(6) 2021, 1012 DAYS POST INDEX PROCEDURE, THE 60% STENOSIS PROXIMAL TO MID SFA WITH LESION LENGTH 120 MM AND REFERENCE VESSEL DIAMETER OF 5 MM WAS TREATED WITH 6 MM NON-BOSTON SCIENTIFIC EMBOLIC PROTECTION SYSTEM IS INSERTED AND ATHERECTOMY WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC 6F DIRECTIONAL ATHERECTOMY SYSTEM TO THE AFOREMENTIONED LESIONS WITH MULTIPLE PASSAGES OF THE STENOSIS, EXTRACTION OF SOFT AND HARD PLAQUE DURING THIS. SUBSEQUENT DRUG ELUTING BALLOON ANGIOPLASTY OF THE ATHERECTOMY WITH LESIONS OF THE POPLITEAL ARTERY IN SEGMENT II, ADJACENT TO THE STENT AS WELL AS ISR AND OF THE PROXIMAL SFA WITH NON-BOSTON SCIENTIFIC DRUG ELUTING BALLOONS 4 MM X 40 MM, 5 MM X 21 MM AND 5 MM X40 MM. WHEN REMOVING THE NON-BOSTON SCIENTIFIC EMBOLIC PROTECTION SYSTEM, EMBOLI ARE EXTRICATED. POST-TREATMENT, NO EVIDENCE OF ANY REMAINING STENOSES IN THE FINAL ANGIOGRAPHY AND IMPROVED HEMODYNAMICS AT THE LOWER LEG AND NO PERIPHERAL COMPLICATIONS NOTED, RESULTING INTO 10% RESIDUAL STENOSIS. THE SUBJECT WAS RECOMMENDED CONTINUING ASA 100 MG/DAY AS PERMANENT THERAPY AND CLOPIDOGREL 75 MG/DAY FOR 12 WEEKS AS WELL, ALONG WITH THROMBOLYSIS PROPHYLAXIS FOR 24 HOURS. ON (B)(6) 2021, THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED. ON (B)(6) 2021, ABI WAS AT DORSALIS PEDIS ARTERY WAS 0.97 AND POSTERIOR TIBIAL ARTERY WAS AT 1.02. ON (B)(6) 2011, THE SUBJECT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909508 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0021431429

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention