BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA ENDOVASCULAR STENT GRAFT

    MDR report key: 6833460 · Received August 31, 2017

    Report

    Report Number
    2953200-2017-01363
    Event Type
    Injury
    Date Received
    August 31, 2017
    Date of Event
    February 26, 2016
    Report Date
    September 13, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE TITLE; LATE RADIOLOGICAL AND CLINICAL OUTCOMES OF TRAUMATIC THORACIC AORTIC INJURY MANAGED WITH THORACIC ENDOVASCULAR AORTIC REPAIR. M. KHASHRAM, Q. HE, T. H. OH, A. KHANAFER, I. A. WRIGHT, T. M. VASUDEVAN, A. S. N. LO, J. A. ROAKE, I. CIVIL. WORLD J SURG (2016) 40:1763¿1770 DOI 10.1007/S00268-016-3457-6.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE AUTHOR DETERMINED THAT EARLY COMPLICATIONS WERE UNRELATED TO THE DEVICE. THE AUTHOR NOTED THAT DURING THE REALIGNMENT, 5.5 YEARS FOLLOWING THE INJURY, THE SUBCLAVIAN ARTERY WAS COVERED. THE MAX AORTA WAS 26 MM IN DIAMETER AT THE TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT TRAUMATIC THORACIC AORTIC INJURY. THE PATIENT WAS DIAGNOSED WITH AN AORTIC TRANSECTION FOLLOWING AN MVC. THE PATIENT WAS TREATED 6-H POST-PRESENTATION WITH A 30 MM X 100 MM VALIANT MEDTRONIC STENT GRAFT. DURING SURVEILLANCE, THE PATIENT DEVELOPED A TYPE 1B ENDOLEAK 5.5 YEARS FOLLOWING THE INJURY. FEATURES OF THE ENDOLEAK WERE SEEN ON X-RAY AND CONFIRMED BY CTA. THE PATIENT UNDERWENT RELINING OF THE STENT GRAFT AND DISTAL EXTENSION. POST-PROCEDURAL CT SHOWED RESOLUTION OF ENDOLEAK. ABSTRACT: PURPOSE PATIENTS TREATED WITH THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR TRAUMATICTHORACIC AORTIC INJURY (TTAI) ARE OFTEN YOUNG AND DATA ON LONG-TERM DURABILITY OF THIS TREATMENT IS NOT WIDELY DOCUMENTED. THE AIMS OF THIS STUDY WERE TO REPORT THE (B)(6) NATIONAL EXPERIENCE OF TEVAR AND TO ASSESS THE DURABILITY OF LATE OUTCOMES AND RADIOLOGICAL FOLLOW-UP OF PATIENTS TREATED FOR TTAI. METHODS: CONSECUTIVE PATIENTS TREATED WITH TEVAR DURING A 12-YEAR PERIOD FROM ALL TERTIARY CENTERS IN (B)(6) WERE INCLUDED. EARLY (30-DAY), LATE SURVIVAL AND RADIOLOGICAL IMAGING DATA WERE RECORDED TO DOCUMENT LATE GRAFT-RELATED COMPLICATIONS AND RE-INTERVENTIONS. RESULTS: 88 PATIENTS WITH A MEDIAN (RANGE) AGE OF 35 (15¿87) YEAR AND 63 (71.6 %) MALES WERE INCLUDED. ELEVEN PATIENTS (12.5 %) DIED WITHIN 30 DAYS, OF WHICH THREE WERE AORTIC RELATED DEATHS. THE MEDIAN (RANGE) FOLLOW-UP WAS 76.3 (0.3¿164.6) MONTHS. SIX (7.8 %) PATIENTS DIED DURING THE FOLLOW-UP PERIOD DUE TO NON-AORTIC-RELATED CAUSES. NINE (11.5 %) PATIENTS WERE LOST TO FOLLOW-UP OF WHICH THREE EMIGRATED OVERSEAS. OF THOSE ON SURVEILLANCE, TWO PATIENTS REQUIRED TEVAR RE-INTERVENTION TO PREVIOUSLY TREATED AORTIC SEGMENTS; ONE FOR A TYPE 1B ENDOLEAK AND THE OTHER FOR A SYMPTOMATIC PSEUDO-COARCTATION. BOTH WERE TREATED SUCCESSFULLY WITH A TEVAR. CONCLUSIONS: THIS MULTICENTER STUDY SUGGESTS THAT TEVAR IS A DURABLE OPTION FOR TREATMENT OF TRAUMATIC THORACIC AORTIC INJURY. ALTHOUGH, STENT GRAFT COMPLICATIONS WERE UNCOMMON, BUT WHEN IT OCCURRED, IT LEADS TO RE-INTERVENTION. FURTHER RADIOLOGICAL FOLLOW-UP IS REQUIRED PARTICULARLY IN YOUNG PATIENT TO DOCUMENT LATE AORTIC/STENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614883 VALIANT CAPTIVIA ENDOVASCULAR STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention