BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3214060 · Received July 9, 2013

    Report

    Report Number
    2953200-2013-01291
    Event Type
    Death
    Date Received
    July 9, 2013
    Date of Event
    May 9, 2009
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION, DEATH, MI, SURGICAL TRANSPOSITION OF THE LSA TO THE LCCA, ISCHEMIA, ARM WEAKNESS, ARM PA RAESTHESIA, STROKE, PARAPLEGIA, SNORKELLING BYPASS); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY DISSECTED THORACIC AORTA, AND TYPE II ENDOLEAKS). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY DISSECTED THORACIC AORTA, AND TYPE II ENDOLEAKS).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; MANAGEMENT STRATEGIES FOR THORACIC STENT-GRAFT REPAIR OF DISTAL AORTIC ARCH LESIONS: IS INTENTIONAL SUBCLAVIAN ARTERY OCCLUSION A SAFE PROCEDURE? FABRIZIO FANELLI; MICHAEL D. DAKE; FILIPPO MARIA SALVATORI; ARMANDO PUCCI; GIUSEPPE MAZZESI; PIERLEONE LUCATELLI; PLINIO ROSSI; ROBERTO PASSARIELLO. EUR RADIOL (2009) 19: 2407¿2415. THIS IS A RETROSPECTIVE STUDY PERFORMED ON 73 PATIENTS WITH THORACIC AORTIC ANEURYSMS OF THE DESCENDING AORTA (TAA) OR TYPE B DISSECTIONS (TAD) TREATED IN OUR DEPARTMENT WITH THORACIC STENT-GRAFT IMPLANTATION BETWEEN DECEMBER 2000 AND DECEMBER 2007. FORTY-SEVEN PATIENTS (64.4%), 40 MEN AND 7 WOMEN WITH A MEAN AGE OF 61.4 YEARS (RANGE 31¿83 YEARS), UNDERWENT THORACIC STENT-GRAFT PLACEMENT FOR ACUTE (N=24) OR CHRONIC (N=23) TAD,WHILE 26 PATIENTS (35.6%), 23 MEN AND 3 WOMEN WITH A MEAN AGE OF 67.3 YEARS (RANGE 32¿83 YEARS), WERE TREATED FOR TAA. IN THIS STUDY WE EVALUATED ONLY 37 PATIENTS (50.7%) WITH A SHORT PROXIMAL NECK (LESS THAN 20 MM) INCLUDING 27 OF THE 47 PATIENTS WITH TAD (57.4%) AND 10 TAA PATIENTS (38.5%) OUT OF THE 26 TREATED. INTENTIONAL COVERAGE AND EXCLUSION OF THE ORIGIN OF THE LSA BY THE AORTIC ENDOPROSTHESIS WAS PERFORMED IN ALL 37 PATIENTS WITH SHORT (LESS THAN 2 CM) PROXIMAL NECK: 10 OF THE 26 PATIENTS WITH TAA AND 27 OF THE 47 PATIENTS WITH TAD. AFTER A MEAN FOLLOW-UP OF 43.70±24.01 MONTHS (RANGE 2¿91 MONTHS) THE RESULTS FOR THE 37 PATIENTS IN WHICH THE LSA WAS INTENTIONALLY COVERED BY THE ENDOPROSTHESIS INCLUDED: . TECHNICAL SUCCESS¿COMPLETE EXCLUSION OF THE ANEURYSM SAC OR OF THE FALSE LUMEN WAS ACHIEVED IN ALL PATIENTS. NO EVIDENCE OF ENDOLEAK WAS PRESENT ON ANY OF THE FINAL ARTERIOGRAMS PERFORMED IMMEDIATELY AFTER STENT-GRAFT DEPLOYMENT AND AT THE CTA DONE BEFORE DISCHARGE. . PERIPROCEDURAL COMPLICATIONS¿IN TWO CASES OF AORTIC DISSECTION(5.4%), COMPLICATIONS OF THE STENT-GRAFT PROCEDURE WERE NOTED. ONE PATIENT DEVELOPED A RETROGRADE EXTENSION OF A TYPE B DISSECTION INTO THE ASCENDING AORTA (TYPE A) IMMEDIATELY AFTER DEPLOYMENT OF A TAG ENDOPROSTHESIS (WL GORE <(>&<)> ASSOCIATES, (B)(4) USA). THIS COMPLICATION WAS MANAGED SUCCESSFULLY WITH SURGICAL REPAIR. THE OTHER PATIENT EXPERIENCED TEMPORARY PARAPARESIS AFTER STENT-GRAFT DEPLOYMENT. A TAG (31×150 MM) ENDOPROSTHESIS (WL GORE <(>&<)> ASSOCIATES, (B)(4) USA) WAS RELEASED LANDING AT THE LEVEL OF T6. THE SYMPTOMS IMPROVED AFTER A FEW HOURS AND BY 48 H AFTER ONSET, ALL NEUROLOGICAL SYMPTOMS HAD COMPLETELY RESOLVED WITH ONLY SUPPORTIVE THERAPY. NO CASES OF PERMANENT PARAPARESIS OR PARAPLEGIA WERE REPORTED DURING THE FOLLOW-UP. SURVIVAL¿MORTALITY¿OF 37 PATIENTS 31 (83.8%) ARE ALIVE AND IN GOOD CLINICAL CONDITION. A 30-DAY MORTALITY RATE OF 5.4% (2 OF 37 PATIENTS, BOTH IN THE TAA GROUP) WAS OBSERVED. ONE PATIENT DIED 20 DAYS AFTER THE PROCEDURE FOLLOWING AN ACUTE MYOCARDIAL INFARCTION. THE OTHER DIED 10 DAYS AFTER STENT-GRAFT DEPLOYMENT FROM AN ACUTE RUPTURE OF AN UNTREATED COEXISTING ABDOMINAL AORTIC ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313654 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Death| R