BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA

    MDR report key: 6838267 · Received September 1, 2017

    Report

    Report Number
    2953200-2017-01386
    Event Type
    Injury
    Date Received
    September 1, 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

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; 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) WORLD J SURG (2016) 40:1763¿1770 DOI 10.1007/S00268-016-3457-6. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE AUTHOR DETERMINED THAT THE EARLY COMPLICATIONS WERE UNRELATED TO THE DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TRAUMATIC THORACIC AORTIC INJURY. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, AORTIC RUPTURE POST TEVAR, CONVERSION TO OPEN REPAIR, COVERED LEFT SUBCLAVIAN ARTERY, SUBCLAVIAN-STEAL SYNDROME CAUSING COMPROMISE OF A PREVIOUS CORONARY BYPASS GRAFT. PURPOSE: PATIENTS TREATED WITH THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) FOR TRAUMATIC THORACIC 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
    617835 VALIANT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND VAMF3030C100TE

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention