BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    MDR report key: 10426241 · Received August 19, 2020

    Report

    Report Number
    2134265-2020-11310
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 29, 2020
    Report Date
    April 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIU
    PMA / PMN Number
    P180011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: (B)(6). A2 AGE AT TIME OF EVENT: 68 YEARS OLD AT TIME OF ENROLLMENT E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER ADDRESS 1: (B)(6). B5: DESCRIBE EVENT OR PROBLEM AND H6: PATIENT CODES WERE UPDATED.

    Description of Event or Problem · 0

    EMINENT CLINICAL STUDY: IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE STUDY STENT ON (B)(6) 2019. THE TARGET LESION WAS LOCATED IN RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) INVOLVING PULMONARY PERIPHERAL ARTERY (PPA) WITH 100% STENOSIS AND WAS 140 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM AND WAS CLASSIFIED AS TASC II B LESION. THE LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF 6 MM X 120 MM AND 6 MM X 60 MM STUDY STENTS. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2019, SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2020, THE SUBJECT WAS DIAGNOSED WITH RE-OCCLUSION OF THE TARGET VESSEL IN THE SFA PROXIMAL RIGHT LEG RELATING TO THE 6 MM X 120 MM STUDY STENT. NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT AND THE EVENT WAS CONSIDERED ONGOING. IT WAS FURTHER CLARIFIED THAT THE TARGET LESION WAS LOCATED IN THE RIGHT DISTAL SFA INVOLVING THE PROXIMAL POPLITEAL ARTERY (PPA). ON (B)(6) 2019, BASELINE ANGIOGRAPHY ANALYSIS BY CORE LAB REVEALED TARGET LESION IN RIGHT DISTAL SFA INVOLVING PPA WITH ISOCENTER CALIBRATION AND UNKNOWN AXIS. MILD CALCIFICATION WAS NOTED WITH ABSENCE OF THROMBUS, ULCERATION AND ANEURYSM. ON (B)(6) 2020, THE SUBJECT PRESENTED FOR PROTOCOL SCHEDULED 12-MONTH FOLLOW-UP VISIT AND COMPLAINED OF SYMPTOMS OF MODERATE DEGREE OF DIFFICULTY IN WALKING WITH CLINICAL RESTRICTION OF A WALKING DISTANCE UP TO APPROXIMATELY 100 METERS AND MUCH DEGREE OF PAIN, ACHING, AND CRAMPS IN THE RIGHT LEG. RUTHERFORD CLASSIFICATION ON THE SAME DAY WAS AT 3 (SEVERE CLAUDICATION). ANKLE BRANCHIAL INDEX (ABI) PERFORMED ON THE SAME DAY IN TARGET LIMB WAS AT 0.4. DOPPLER ULTRASOUND PERFORMED ON THE SAME DAY REVEALED RE-OCCLUSION OF RIGHT PROXIMAL SFA. UPON CONSULTATION, THE SUBJECT WAS RECOMMENDED TO UNDERGO INTERVENTIONAL PROCEDURE ON A LATER DATE. ON (B)(6) 2020, THE SUBJECT WAS HOSPITALIZED FOR PLANNED INTERVENTION. BASED ON THE CLINICAL SYMPTOMS, THE SUBJECT WAS CLASSIFIED AS FONTAINE IIB PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (PAOD) ON THE RIGHT. AT THE TIME OF REPORTING OF THE EVENT, THE SUBJECT WAS ON ASPIRIN, CLOPIDOGREL AND OTHER ANTICOAGULATION THERAPY (MARCUMAR) TO TREAT THE ATRIAL FIBRILLATION. ON PHYSICAL EXAMINATION, BOTH FEET WERE COLD MORE PRONOUNCED ON RIGHT THAN THE LEFT AND PERIPHERAL PULSES WERE NOT PALPABLE. ON (B)(6) 2020, PRE-INTERVENTIONAL ANGIOGRAPHY PERFORMED REVEALED SFA WITH HIGHEST GRADE STENOSIS AT THE OUTFLOW, THEN CLEAR AND STENTED AFTER APPROXIMATELY 1 CM, THE STENT WAS PERFUSED TO APPROXIMATELY 1 CM LENGTH AND THEN COMPLETELY OCCLUDED, REPERFUSION OF THE POPLITEAL ARTERY IN SEGMENT 3, TRIPLE VESSEL OUTFLOW AT THE LOWER LEG WAS NOTED. ADDITIONAL ANGIOGRAPHY ASSESSED BY CORE LAB REVEALED RIGHT DISTAL SFA INVOLVING PPA WITH NOT PATENT INFLOW AND PATENT OUTFLOW, OCCLUSIVE IN-STENT RESTENOSIS PATTERN WITH PRESENCE OF THROMBUS AND ABSENCE OF ANEURYSM. THE 100% STENOSIS IN THE RIGHT PROXIMAL TO DISTAL SFA INCLUDING PPA (TARGET LESION) WHICH HAD UNKNOWN LESION LENGTH WITH 6MM REFERENCE VESSEL DIAMETER WAS TREATED WITH ATHERECTOMY-ASSISTED RECANALIZATION WITH 4F NON-BOSTON SCIENTIFIC CATHETER AND 6F NON-BOSTON SCIENTIFIC ATHERECTOMY SYSTEM AND THE RESIDUAL STENOSIS HERE, WAS TREATED WITH A 4 MM X 40 MM STERLING BALLOON. FOLLOWING RECANALIZATION, LONG-STRETCH DRUG-COATED BALLOON ANGIOPLASTY WAS PERFORMED WITH TWO 6 MM X 150 MM RANGER BALLOONS FROM THE OUTFLOW OF THE SFA THROUGH TO THE POPLITEAL ARTERY IN SEGMENT 3. ALSO, THERE WAS A RELEVANT RECOIL NOTED IN MID SFA, WHICH WAS TREATED WITH 7 MM X 125 MM NON-BOSTON SCIENTIFIC STENT FOLLOWED BY SUBSEQUENT DILATION WITH A 6 MM X 150MM RANGER BALLOON. POST TREATMENT 10 % RESIDUAL STENOSIS WAS NOTICED. NO THROMBUS WAS SEEN AT THE END OF THE TREATMENT. ON (B)(6) 2020, DOPPLER OCCLUSION PRESSURE MEASUREMENT SHOWED GOOD OUTCOME AFTER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WITH ABI 1.1 ON THE RIGHT. ON THE SAME DAY, ELECTRONIC SEGMENT OSCILLOGRAPHY REVEALED, BOTH UPPER LEG AND ANKLE WERE MILDLY PATHOLOGICAL. COLOR DUPLEX ULTRASOUND OF THE UPPER LEG ARTERIES REVEALED, SFA STENTED, OPEN THROUGH TO THE DISTAL REGION AND POPLITEAL ARTERY WITH NO RELEVANT RESIDUAL STENOSES NOTED. ON (B)(6)2020, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY. IT WAS RECOMMENDED TO CONTINUE MARCUMER (AS PER INR WITH TARGET RANGE OF 2/3), CLOPIDOGREL 75 MG FOR 3 MONTHS AND WAS ADVISED OF THE NECESSITY OF NICOTINE ABSTINENCE TO PREVENT FURTHER PROGRESSION OF PAOD.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE STUDY STENT ON (B)(6) 2019. THE TARGET LESION WAS LOCATED IN RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) INVOLVING PULMONARY PERIPHERAL ARTERY (PPA) WITH 100% STENOSIS AND WAS 140 MM LONG WITH A PROXIMAL REFERENCE VESSEL DIAMETER OF 5 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 5 MM AND WAS CLASSIFIED AS TASC II B LESION. THE LESION WAS TREATED WITH PRE-DILATATION FOLLOWED BY PLACEMENT OF 6 MM X 120 MM AND 6 MM X 60 MM STUDY STENTS. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. ON 1 AUG 2019, SUBJECT WAS DISCHARGED WITH ANTIPLATELET THERAPY. ON (B)(6) 2020, THE SUBJECT WAS DIAGNOSED WITH RE-OCCLUSION OF THE TARGET VESSEL IN THE SFA PROXIMAL RIGHT LEG RELATING TO THE 6 MM X 120 MM STUDY STENT. NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT AND THE EVENT WAS CONSIDERED ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891567 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU BOSTON SCIENTIFIC CORPORATION 24653 0023541897

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R 6X60 ELUVIA STENT| 6X60 ELUVIA STENT| 6X60 ELUVIA STENT