BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABRE VENOUS SELF-EXPANDING STENT SYSTEM

    MDR report key: 24697827 · Received March 26, 2026

    Report

    Report Number
    2183870-2026-00135
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    January 5, 2026
    Report Date
    March 26, 2026
    Manufacturer
    COVIDIEN
    Product Code
    QAN
    PMA / PMN Number
    P200026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MULTIDISCIPLINARY MANAGEMENT OF A PATIENT WITH INFECTED ILIOCAVAL STENTS AND UTERINE CANCER INVASION PUBLISHED BY ELSEVIER INC. ON BEHALF OF SOCIETY FOR VASCULAR SURGERY. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY-NC-ND LICENSE (HTTP:// CREATIVECOMMONS.ORG/LICENSES/BY-NC-ND/4.0/). HTTPS://DOI.ORG/10.1016/J.JVSCIT.2026.102128 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

    ABSTRACT FEMALES WITH GYNECOLOGICAL CANCER HAVE AN INCREASED RISK OF DEEP VEIN THROMBOSIS RELATED TO HYPERCOAGULABILITY AND MECHANICAL COMPRESSION ON ADJACENT VEINS. THIS REPORT DISCUSSES THE MULTIDISCIPLINARY MANAGEMENT OF A PATIENT WITH THROMBOSIS AND INFECTION OF ILIOCAVAL STENTS OWING TO RECURRENT UTERINE CARCINOMA INVASION, REQUIRING EN BLOC RESECTION OF THE MASS WITH CURATIVE ONCOLOGICAL AND INFECTIOUS INTENT. A TWO-STAGE PROCEDURE WAS PERFORMED. THE FIRST STAGE INVOLVED AN EXTRA-ANATOMICAL LEFT AXILLARY TO SUPERFICIAL FEMORAL ARTERY BYPASS AND EMBOLIZATION OF THE LEFT EXTERNAL ILIAC ARTERY. THE SECOND STAGE ENTAILED RADICAL RESECTION OF THE MASS AND LEFT ILIAC VESSELS, INCLUDING THE INFECTED STENTS. (J VASC SURG CASES INNOV TECH 2026;12:102128.) KEYWORDS: VENOUS STENT INFECTION; ILIAC STENTING; VENOUS THROMBOEMBOLISM; DEEP VENOUS THROMBOSIS; UTERINE CANCER; TUMOR INVASION; OPEN RESECTION; MULTIDISCIPLINARY MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756630 ABRE VENOUS SELF-EXPANDING STENT SYSTEM STENT, ILIAC VEIN QAN COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention| O