BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 6132669 · Received November 29, 2016

    Report

    Report Number
    2953200-2016-02039
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    April 15, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM THE JOURNAL ARTICLE ENTITLED ¿COMPLEMENTARY ROLES OF OPEN AND HYBRID APPROACHES TO THORACOABDOMINAL AORTIC ANEURYSM REPAIR¿ EHSAN BENRASHID, MD, HANGHANG WANG, MD, NICHOLAS D. ANDERSEN, MD, JEFFREY E. KEENAN, MD, RICHARD L. MCCANN, MD, AND G. CHAD HUGHES, MD. ((J VASC SURG 2016;64:1228-38). A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD A TYPE III ENDOLEAK 1008 DAYS AFTER THE INITIAL PROCEDURE. ADDITIONAL ENDOVASCULAR REPAIR WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. OBJECTIVE: THORACOABDOMINAL AORTIC ANEURYSM (TAAA) REPAIR REMAINS A SIGNIFICANT CHALLENGE WITH CONSIDERABLE PERIOPERATIVE MORBIDITY AND MORTALITY. A HYBRID APPROACH UTILIZING VISCERAL DEBRANCHING WITH ENDOVASCULAR ANEURYSM EXCLUSION HAS BEEN USED TO TREAT HIGH-RISK PATIENTS AND THEREFORE ALLOW REPAIR IN MORE PATIENTS. LIMITED DATA EXIST REGARDING LONG-TERM OUTCOMES WITH THIS PROCEDURE AS WELL AS COMPARISON TO CONVENTIONAL OPEN REPAIR. THIS STUDY DESCRIBES OUR INSTITUTIONAL ALGORITHMIC APPROACH TO TAAA REPAIR USING BOTH OPEN AND HYBRID TECHNIQUES. METHODS: HYBRID AND OPEN TAAA REPAIRS PERFORMED BETWEEN JULY 2005 AND AUGUST 2015 WERE IDENTIFIED FROM A PROSPECTIVELY MAINTAINED INSTITUTIONAL AORTIC SURGERY DATABASE. PERIOPERATIVE MORBIDITY AND MORTALITY, FREEDOM FROM REINTERVENTION, AND LONG-TERM AND AORTA-SPECIFIC SURVIVAL WERE CALCULATED AND COMPARED BETWEEN THE TWO GROUPS. RESULTS: DURING THE STUDY PERIOD, 165 CONSECUTIVE TAAA REPAIRS WERE PERFORMED, INCLUDING 84 OPEN REPAIRS AND 81 HYBRID REPAIRS. PATIENTS IN THE HYBRID REPAIR GROUP WERE SIGNIFICANTLY OLDER, WERE MORE FREQUENTLY FEMALE, AND HAD A GENERALLY GREATER COMORBID DISEASE BURDEN, INCLUDING SIGNIFICANTLY MORE CHRONIC KIDNEY DISEASE. DESPITE THE OLDER AND SICKER COHORT, THERE WAS NO DIFFERENCE IN IN-HOSPITAL MORTALITY BETWEEN THE TWO GROUPS (9.9% HYBRID VS 7.1% OPEN; P = .59). MAJOR MORBIDITY RATES DIFFERED BY PROCEDURE, WITH PATIENTS UNDERGOING OPEN REPAIR HAVING A SIGNIFICANTLY HIGHER RATE OF POSTOPERATIVE STROKE (9.5% OPEN VS 0% HYBRID; P = .017), WHEREAS PATIENTS UNDERGOING HYBRID REPAIR HAD A HIGHER RATE OF NEW PERMANENT DIALYSIS (14.8% HYBRID VS 3.6% OPEN; P = .043). THERE WAS NO DIFFERENCE BETWEEN GROUPS IN THE RATE OF POSTOPERATIVE PERMANENT PARAPLEGIA/PARESIS (8.3% OPEN VS 7.4% HYBRID; P = .294). THERE WAS A SIGNIFICANTLY INCREASED RATE OF REINTERVENTION IN THE HYBRID REPAIR GROUP (12.3% HYBRID VS 1.2% OPEN, P = .004), WITH ALL HYBRID REINTERVENTIONS PERFORMED BECAUSE OF ENDOLEAK. ONE-YEAR SURVIVAL WAS SIMILAR BETWEEN GROUPS AT 69% IN HYBRID REPAIRS VS 77% IN OPEN REPAIRS. LONG-TERM SURVIVAL WAS WORSE IN THE HYBRID GROUP (5-YEAR SURVIVAL, 32% HYBRID VS 56% OPEN), ALTHOUGH LATE SURVIVAL APPEARED TO BE INFLUENCED MAINLY BY COMORBID DISEASE BURDEN, GIVEN THE SIMILAR LONG-TERM AORTA-SPECIFIC SURVIVAL BETWEEN GROUPS. CONCLUSIONS: USE OF AN ALGORITHMIC APPROACH WHEREBY HIGHER RISK PATIENTS WITH TAAA ARE TREATED BY A HYBRID APPROACH AND LOWER RISK PATIENTS WITH CONVENTIONAL OPEN REPAIR YIELDS SATISFACTORY SHORT- AND LONG-TERM OUTCOMES. THE AVAILABILITY OF MULTIPLE OPTIONS FOR TAAA REPAIR WITHIN A SINGLE CENTER LIKELY ALLOWS REPAIR IN MORE PATIENTS WITH CONSEQUENT DECREASE IN THE RISK OF AORTA-RELATED DEATH, AT THE EXPENSE OF INCREASED REINTERVENTIONS FOR ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783530 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention