BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 5112499 · Received September 29, 2015

    Report

    Report Number
    2953200-2015-01658
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    June 30, 2015
    Report Date
    September 8, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATES OF THE EVENTS ARE UNKNOWN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; OUTCOMES OF SECONDARY PROCEDURES AFTER PRIMARY THORACIC ENDOVASCULAR AORTIC REPAIR. MICHAL NOZDRZYKOWSKI, MAXIMILIAN LUEHR, JENS GARBADE, ANDREJ SCHMIDT, SERGEY LEONTYEVA, MARTIN MISFELD, FRIEDRICH-WILHELM MOHR AND CHRISTIAN D. ETZ (EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY (2015) 1-8) DOI:10.1093/EJCTS/EZV279. A VALIANT, VALIANT CAPTIVA AND TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE SECONDARY ENDOVASCULAR INTERVENTION OF STENT GRAFT RELATED COMPLICATIONS. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: PARAPLEGIA, STROKE, TYPE IB ENDOLEAK, TYPE IA ENDOLEAK, TYPE III ENDOLEAK, SEPSIS, RETROGRADE TYPE A DISSECTION, FISTULA, INFECTION MALPERFUSION SYNDROME, RENAL FAILURE, RESPIRATORY FAILURE, HEAT FAILURE. OBJECTIVES: THE PURPOSE OF THIS STUDY IS TO RETROSPECTIVELY EVALUATE, WITH AN 'ALL-COMERS' APPROACH, THE SURVIVAL AND OUTCOME OF PATIENTS FOLLOWING SECONDARY SURGICAL OR INTERVENTIONAL PROCEDURES AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). METHODS: BETWEEN OCTOBER 2002 AND DECEMBER 2013, 371 PATIENTS WITH DIFFERENT AORTIC PATHOLOGIES UNDERWENT PRIMARY TEVAR AT OUR INSTITUTION. FIFTY-SIX OUT OF THE 371 PATIENTS (15.1%, 18 FEMALES, MEAN AGE 62.3 +/- 13.7 YEARS) REQUIRED SECONDARY PROCEDURES, EITHER INTERVENTIONALLY (N = 31; 55.4%) OR SURGICALLY (N = 25; 44.6%), DUE TO STENT GRAFT-RELATED COMPLICATIONS. AFTER TEVAR COMPLICATIONS COMPRISED ENDOLEAKS (N = 28; 7.5%), ORGAN MALPERFUSION (N = 9; 2.4%), AORTO-OESOPHAGEAL/-BRONCHIAL FISTULAE (N = 9; 2.4%), STENT GRAFT INFECTIONS (N = 4; 1.1%), ANEURYSM PROGRESSION (N = 3; 0.8%), RETROGRADE TYPE A AORTIC DISSECTION (N = 2; 0.5%) AND AORTIC REGURGITATION (N = 1; 0.3%). RESULTS: THE OVERALL IN-HOSPITAL MORTALITY RATE WAS 10.7% (N = 5): OPEN SURGERY (N = 1; 4%) VERSUS REINTERVENTION (N = 5; 16%; P = 0.14). THE CUMULATIVE SURVIVAL RATES AFTER SECONDARY PROCEDURES AT 6 MONTHS, 1 YEAR AND 3 YEARS WERE 80.4, 73.5 AND 69.3%, RESPECTIVELY. POSTOPERATIVE COMPLICATIONS EITHER FOR OPEN SURGERY OR REINTERVENTION COMPRISED STROKE (8 VS 9.6%; P = 0.82), PARAPLEGIA (4 VS 6.4%; P = 0.68), RENAL FAILURE (16 VS 3.2%; P = 0.09), RESPIRATORY FAILURE (12 VS 0%; P = 0.04), SEPSIS (16 VS 3.2%; P = 0.87), ORGAN MALPERFUSION (4 VS 3.2%; P = 0.87) AND NEED FOR A TERTIARY PROCEDURE (8 VS 6.4%; P = 0.82). CONCLUSIONS: STENT GRAFT COMPLICATIONS AFTER PRIMARY TEVAR WERE NOT INFREQUENT AND OFTEN REQUIRED SECONDARY PROCEDURES FOR DEFINITE TREATMENT. ENDOLEAKS (TYPE IA), ORGAN MALPERFUSION, STENT GRAFT INFECTIONS, FISTULA FORMATION AND EXPANDING ANEURYSM OCCURRED PREDO MINANTLY DURING EARLY AND MID-TERM FOLLOW-UP. DESPITE THE HIGH-RISK NATURE OF THE COMPLICATIONS, SECONDARY OPEN SURGICAL OR INTERVENTIONAL PROCEDURES MAY BE SUCCESSFULLY PERFORMED WITH AN ACCEPTABLE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642811 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention