BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABRE VENOUS SELF-EXPANDING STENT SYSTEM

    MDR report key: 21771228 · Received April 4, 2025

    Report

    Report Number
    2183870-2025-00162
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    January 1, 2016
    Report Date
    April 4, 2025
    Manufacturer
    COVIDIEN
    Product Code
    QAN
    PMA / PMN Number
    P200026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    OBJECTIVE: VENOUS STENTING HAS BECOME THE STANDARD OF CARE FOR PATIENTS WITH ILIOFEMORAL VENOUS STENOSIS WHO HAVE FAILED CONSERVATIVE THERAPY. ALTHOUGH OUTCOME DATA FOLLOWING SUCH STENTING EXIST FOR WALLSTENTS AND WALLSTENT-ZENITH (Z) STENT COMBINATION, SUCH DATA FOR DEDICATED STENTS IS SPARSE OUTSIDE OF INDUSTRY-SPONSORED TRIALS. THIS STUDY AIMS TO ADDRESS THIS GAP BY COMPARING THE OUTCOMES OF MATCHED COHORTS OF LIMBS THAT UNDERWENT STENTING WITH EITHER THE MEDTRONIC ABRE STENT (MEDTRONIC INC), THE BARD VENOVO STENT (BECTON, DICKINSON, AND CO), OR WALLSTENT-Z STENT COMBINATION (BOSTON SCIENTIFIC; COOK MEDICAL INC). METHODS: CONTEMPORANEOUSLY ENTERED DATA ON MATCHED COHORTS OF PATIENTS WHO UNDERWENT STENTING FROM 2016 TO 2022 FOR QUALITY OF LIFE (QOL)-IMPAIRING ILIOFEMORAL VENOUS STENOSIS (NOT OCCLUSION) AFTER FAILING CONSERVATIVE THERAPY WAS ANALYZED. THE VENOUS CLINICAL SEVERITY SCORE (VCSS, 0-27), GRADE OF SWELLING (GOS, 0-4), VISUAL ANALOG SCALE PAIN SCORE (VAS PAIN SCORE, 0-10), AND CIVIQ-20 QOL SCORES WERE EVALUATED INITIALLY AND POST STENTING TO ASSESS THE EFFECTS OF STENTING. ANALYSIS OF VARIANCE AND PAIRED T-TESTS WERE USED TO COMPARE CLINICAL AND QOL VARIABLES, WHEREAS KAPLAN-MEIER ANALYSIS WAS USED TO EXAMINE PRIMARY, PRIMARY-ASSISTED, AND SECONDARY STENT PATENCIES, WITH LOG-RANK TEST USED TO DISCRIMINATE BETWEEN DIFFERENT CURVES. RESULTS: THERE WERE A TOTAL OF 198 LIMBS THAT HAD UNDERGONE STENTING, INCLUDING 68 IN THE ABRE, 60 IN THE VENOVO AND 70 IN THE WALLSTENT-Z STENT GROUPS. THE MEDIAN AGE FOR THE ENTIRE COHORT WAS 65 YEARS (RANGE, 21-101 YEARS). THE COHORT INCLUDED 141 WOMEN AND 57 MEN. LEFT LATERALITY (112 LIMBS) WAS MORE COMMON THAN RIGHT LATERALITY (86 LIMBS). POST-THROMBOTIC SYNDROME WAS SEEN IN 146 LIMBS AND NONTHROMBOTIC ILIAC VEIN LESIONS/MAY-THURNER SYNDROME IN 52 LIMBS. THE MEDIAN BODY MASS INDEX WAS 35 KG/M2. MEDIAN FOLLOW-UP WAS 20 MONTHS. FOR THE ENTIRE COHORT, POST STENTING, VCSS IMPROVED FROM 6 TO 4.5 AT 3 MONTHS (P .0001), FURTHER IMPROVED TO 4 AT 6 MONTHS (P .0001), AND REMAINED AT 4 AT 12 MONTHS (P .0001) AND 24 MONTHS (P .0001). GOS FOR THE ENTIRE COHORT IMPROVED FROM 3 TO 1 AT 3 MONTHS (P .0001) AND REMAINED AT 1 AT 6 MONTHS, (P .0001), 12 MONTHS (P .0001), AND 24 MONTHS (P .0001). VAS PAIN SCORE FOR THE ENTIRE COHORT IMPROVED FROM 8 TO 2 AT 3 MONTHS (P .0001), INCREASED TO 3 AT 6 MONTHS (P .0001) BEFORE DROPPING TO 2 AT 12 MONTHS (P .0001), AND REMAINED AT 2 AT 24 MONTHS (P .0001). THE CIVIQ-20 SCORE FOR THE ENTIRE COHORT IMPROVED FROM 61 TO 38 (P .0001) OVER THE DURATION OF FOLLOW-UP. THE PRIMARY PATENCIES FOR THE ABRE, BARD, AND WALLSTENT-Z STENT GROUPS AT 32 MONTHS WERE 93%, 86%, AND 92%, RESPECTIVELY (P ¼ .37). PRIMARY ASSISTED PATENCIES FOR ALL THREE GROUPS AT 32 MONTHS WAS 100% (P ¼ .08). THERE WERE NO STENT OCCLUSIONS IN ANY OF THE GROUPS. REINTERVENTION WAS PURSUED FOR QOL-IMPAIRING RECURRENT CLINICAL MANIFESTATIONS IN 13 LIMBS (7%), WITHOUT A SIGNIFICANT DIFFERENCE BETWEEN GROUPS (P ¼ .46). CONCLUSIONS: FOR PATIENTS UNDERGOING STENTING FOR QOL-IMPAIRING SYMPTOMS OF ILIOFEMORAL VENOUS STENOSIS AFTER FAILING CONSERVATIVE THERAPY, ABRE, VENOVO, AND WALLSTENT-Z STENT COMBINATION ALL APPEAR TO PROVIDE SIMILAR CLINICAL AND QOL IMPROVEMENT. A SIGNIFICANT DIFFERENCE BETWEEN STENT PATENCIES FOR THE THREE STENT TYPES WAS ALSO NOT DETECTED. STENT SELECTION FOR TREATMENT OF STENOTIC LESIONS OF THE ILIOFEMORAL VENOUS TERRITORY CAN BE BASED ON STENT AVAILABILITY AND THE PREFERENCE/EXPERTISE OF THE INTERVENTIONALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746031 ABRE VENOUS SELF-EXPANDING STENT SYSTEM STENT, ILIAC VEIN QAN COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention