BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABRE VENOUS SELF-EXPANDING STENT SYSTEM

    MDR report key: 17548020 · Received August 15, 2023

    Report

    Report Number
    2183870-2023-00289
    Event Type
    Death
    Date Received
    August 15, 2023
    Date of Event
    July 31, 2023
    Report Date
    September 29, 2023
    Manufacturer
    COVIDIEN
    Product Code
    QAN
    UDI-DI
    00643169796430
    PMA / PMN Number
    P200026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A PHYSICIAN WAS ATTEMPTING TO IMPLANT AN ABRE STENT FOR THE TREATMENT OF A SOFT TISSUE LESION IN THE DISTAL REGION OF THE SUPERIOR VENA CAVA (SVC). THERE WAS MODERATE TORTUOSITY AND NO CALCIFICATION. ABNORMALITIES RELATING TO THE ANATOMY INCLUDED THE PATIENT HAD SVC SYNDROME WITH A TUMOR PRESSING ON SVC AND STENOSED SVC TO ALMOST TOTAL OCCLUSION. THE DEVICE WAS PREPPED AS PER THE IFU. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. THE PHYSICIAN ACCESSED THROUGH THE LEFT BRACHIAL AND GROIN, THROUGH AND THROUGH WIRES. THE PHYSICIAN PERFORMED THROMBECTOMY USING NON MEDTRONIC DEVICE. PRE-DILATED USING 8MM BALLOON ON THE STENOSED VESSEL. IVUS WAS USED TO MEASURE. THE DEVICE WAS USED OFF-LABEL. THE PHYSICIAN DEPLOYED THE ABRE STENT FROM THE GROIN THROUGH SVC. IT IS REPORTED THERE WAS STENT DEFORMATION IN VIVO POST DEPLOYMENT. STENT APPEARED STRUCTURED AT DISTAL END, POST BALLOON DILATION. UPON POST DILATION OF THE STENOSIS WITH A 16 MM NON-MEDTRONIC BALLOON, THE SVC DISSECTED. THE PHYSICIAN PLACED COVERED STENT ACROSS STENOSIS. THE PATIENT IS DECEASED. CAUSE OF DEATH IS REPORTED AS SVC RUPTURED UPON POST DILATION WITH NON-MEDTRONIC BALLOON. PATIENT HAD BEEN ON LYTICS FOR 48 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994415 ABRE VENOUS SELF-EXPANDING STENT SYSTEM STENT, ILIAC VEIN QAN COVIDIEN B403004 00643169796430

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death| R