BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABRE VENOUS SELF-EXPANDING STENT SYSTEM

    MDR report key: 21764009 · Received April 3, 2025

    Report

    Report Number
    2183870-2025-00161
    Event Type
    Death
    Date Received
    April 3, 2025
    Date of Event
    January 27, 2025
    Report Date
    April 3, 2025
    Manufacturer
    COVIDIEN
    Product Code
    QAN
    PMA / PMN Number
    P200026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL TITLE: SAFETY AND EFFICACY OF THE ABRE¿ VENOUS STENT IN TREATING THORACIC VENOUS STENOSIS/OCCLUSION: A SINGLE-CENTER EXPERIENCE EMERGENCY RADIOLOGY HTTPS://DOI.ORG/10.1007/S10140-025-02316-7 A2 AVERAGE AGE A3 MAJORITY GENDER B3 DATE OF PUBLICATION. 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

    LITERATURE EVENT WAS RECEIVED: THIS STUDY AIMED TO EVALUATE THE CLINICAL OUTCOMES, TECHNICAL SUCCESS, AND COMPLICATIONS ASSOCIATED WITH THE PLACEMENT OF ABRE¿ VENOUS STENTS FOR CENTRAL VENOUS STENOSIS/OCCLUSION (CVS/CVO). MATERIALS AND METHODS A RETROSPECTIVE REVIEW WAS CONDUCTED, IDENTIFYING 21 PATIENTS WHO UNDERWENT ABRE¿ VENOUS STENT PLACEMENT FOR SVC SYNDROME AT A SINGLE INSTITUTION. DEMOGRAPHIC AND CLINICAL DATA WERE COLLECTED, INCLUDING STENT CONFIGURATIONS, PROCEDURAL DETAILS, AND FOLLOW-UP OUTCOMES. PRIMARY STENT PATENCY, SYMPTOM RESOLUTION, AND SURVIVAL RATES WERE ANALYZED. SURVIVAL CURVES WERE GENERATED USING KAPLAN-MEIER ANALYSIS, AND COMPLICATIONS WERE RECORDED. RESULTS FACIAL AND/OR UPPER EXTREMITY EDEMA WAS PRESENT IN ALL PATIENTS, AND MALIGNANCY ACCOUNTED FOR SVC SYNDROME IN 71.4% OF CASES, WITH LUNG CANCER AS THE PREDOMINANT ETIOLOGY (66.6%). THE TECHNICAL SUCCESS RATE WAS 100%. CLINICAL SYMPTOM RESOLUTION WAS ACHIEVED IN ALL PATIENTS. THE 30-DAY MORTALITY RATE WAS 23.8%, WITH ALL CASES INVOLVING ONCOLOGY PATIENTS. AT SIX MONTHS, CROSS-SECTIONAL IMAGING SHOWED A PRIMARY STENT PATENCY RATE OF 93%, AND THIS REMAINED STABLE THROUGH 12 MONTHS. THE MEAN SURVIVAL TIME FOR THE CANCER SUBGROUP WAS 337.2 ± 343 DAYS, WHILE THE OVERALL COHORT MEAN WAS 885.8 ± 453.7 DAYS. CONCLUSION THE ABRE¿ VENOUS STENT DEMONSTRATES POTENTIAL AS AN EFFECTIVE STENT FOR SVC SYNDROME, ACHIEVING HIGH SYMPTOM RELIEF AND PATENCY RATES. HOWEVER, FURTHER LONG-TERM STUDIES AND RANDOMIZED CONTROLLED TRIALS ARE NECESSARY TO VALIDATE THESE FINDINGS. A TOTAL OF 21 PATIENTS WHO UNDERWENT ABRE¿ VENOUS STENT PLACEMENT FOR SUPERIOR VENA CAVA (SVC) SYNDROME WERE IDENTIFIED THROUGH A RETROSPECTIVE INSTITUTIONAL DATABASE REVIEW. SYMPTOM RESOLUTION WAS ACHIEVED IN ALL PATIENTS (100%). THE 30-DAY POST-PROCEDURAL MORTALITY RATE WAS 23.8% (5/21), ALL OF WHOM WERE ONCOLOGY PATIENTS PRESENTING WITH ACUTE SVC SYNDROME AND ASSOCIATED AIRWAY COMPROMISE. AT SIX MONTHS, CROSS-SECTIONAL CT IMAGING WAS AVAILABLE. AT SIX MONTHS, CROSS-SECTIONAL CT IMAGING WAS AVAILABLE FOR 15 PATIENTS (71.4%). SIX PATIENTS WERE EXCLUDED FROM PRIMARY STENT PATENCY ANALYSIS DUE TO DEATH. PRIMARY STENT PATENCY AT SIX MONTHS WAS 93.3% (14/15). ONE PATIENT EXPERIENCED STENT OCCLUSION 59 DAYS POST-DEPLOYMENT DUE TO TUMOR INFILTRATION. THIS PATIENT UNDERWENT ASPIRATION THROMBECTOMY, BALLOON MACERATION, AND PLACEMENT OF A NEW OVERLAPPING STENT. THE RETRIEVED SPECIMEN CONFIRMED MALIGNANT INFILTRATION. THE STENT REMAINED PATENT FOR THE REMAINDER OF THE STUDY PERIOD, SPANNING AN ADDITIONAL 84 DAYS. AT 12 MONTHS, STENT PATENCY REMAINED UNCHANGED FOR THE COHORT. THREE ADDITIONAL PATIENTS WERE EXCLUDED FROM PATENCY ANALYSIS DUE TO DEATH. A PATIENT WITH END-STAGE RENAL DISEASE (ESRD) PRESENTED WITH A CRUSHED SVC STENT AND MULTIFOCAL AREAS OF SEVERE STENOSIS AFTER 4 YEARS. THIS WAS SUCCESSFULLY TREATED WITH ANGIOPLASTY AND THE PLACEMENT OF A NEW STENT WITHIN THE EXISTING SVC STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458788 ABRE VENOUS SELF-EXPANDING STENT SYSTEM STENT, ILIAC VEIN QAN COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death