BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA UNK

    MDR report key: 16775937 · Received April 20, 2023

    Report

    Report Number
    9612164-2023-01689
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    September 2, 2022
    Report Date
    April 20, 2023
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; QUESTIONABLE LONG-TERM RESULTS OF THE EXTENDED PROVISIONAL EXTENSION TO INDUCE COMPLETE ATTACHMENT (E-PETTICOAT) TECHNIQUE IN THE MANAGEMENT OF CHRONIC TYPE B AORTIC DISSECTION. ZOLNIERCZUK M, MISKIEWICZ M, PADUCH J, RYBICKA A, RYNIO P, JEDRZEJCZAK T, PACHOLEWICZ J, GUTOWSKI P, KRAJEWSKA A, KAZIMIERCZAK A ANN VASC SURG 2023; 89: 210¿215 HTTPS://DOI.ORG/10.1016/J.AVSG.2022.08.012 A.2 AND A.3 AVERAGE. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    20 PATIENTS DIAGNOSED WITH A CHRONIC TYPE B AORTIC DISSECTION (CTBAD) UNDERWENT A PROCEDURE THAT UTILIZED THE E-PETTICOAT TECHNIQUE. THE TECHNIQUE INVOLVED THE IMPLANTATION OF A NON MDT NITONOL SELF EXPANDABLE BARE METAL STENT INTO THE THE VISCERAL AND INFRARENAL AORTA. THEN A VALIANT CAPTIVIA IS DEPLOYED PROXIMALLY WITH OVERLAP (TO COVER PROXIMAL ENTRY TEAR), FOLLOWED BY INSERTING 2 COVERED ENDURANT LILAC STENT-GRAFTS BELOW THE RENAL ARTERIES AS PARALLEL KISSING ILIAC STENT-GRAFTS (TO COVER ILIAC RE-ENTRIES). TEVAR PROXIMAL OVERSIZING WAS USUALLY 5% AND VISCERAL BARE-METAL STENT WERE EXTRA LARGE WAS USUALLY 8% . BALLOONING WAS THEN PERFORMED USING A RELIANT BALLOON. THE OVERSIZING WAS BASED ON THE BIGGEST DIAMETER OF THE TRUE LUMEN. THE TECHNICAL SUCCESS (ENTRY COVERAGE AND TL RE EXPANSION) RATE WAS 100%. THE FOLLOWING ADVERSE EVENTS WERE REPORTED; OCCLUSION, AORTIC DEGENERATION (GROWTH RATE OF AORTIC DIAMETER) , RE-INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATH OR A DEATH WAS AS A RESULT OF A MALFUNCTION OR DETERIORATION IN THE PERFORMANCE CHARACTERISTICS OF A MDT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625477 VALIANT CAPTIVIA UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VAL-CAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other| R