BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT

    MDR report key: 3217895 · Received July 10, 2013

    Report

    Report Number
    2953200-2013-01341
    Event Type
    Death
    Date Received
    July 10, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (RETROGRADE TYPE A DISSECTION, RUPTURE, STENT GRAFT MIGRATION, STENT COLLAPSE, ANEURYSMAL DEGENERATION, TYPE I ENDOLEAK, PARAPLEGIA, OCCLUSION, SURGICAL BYPASS, STENT GRAFT-INDUCED DISTAL RE-DISSECTION, SURGICAL CONVERSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVELY DISSECTED THORACIC AORTA); (UNKNOWN CAUSE OF THE EVENT). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVELY DISSECTED THORACIC AORTA); (UNKNOWN CAUSE OF THE EVENT).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; RESTRICTIVE BARE STENT FOR PREVENTION OF STENT GRAFT-INDUCED DISTAL REDISSECTION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR FOR TYPE B AORTIC DISSECTION. JIAXUAN FENG, MD, QINGSHENG LU, MD, ZHIQING ZHAO, MD, JUNMIN BAO, MD, XIANG FENG, MD, LEFENG QU, MD, JIAN ZHOU, PHD, AND ZAIPING JING, MD, SHANGHAI, CHINA (J VASC SURG 2013;57:44S-52S.) BACKGROUND: STENT GRAFT-INDUCED DISTAL REDISSECTION (SIDR) IS ONE OF THE MAJOR CONCERNS IN THE DURABILITY OF ENDOVASCULAR REPAIR FOR COMPLICATED STANFORD TYPE B AORTIC DISSECTION. THE CHARACTERISTICS AND MEANS OF PREVENTION OF THIS COMPLICATION REMAIN UNKNOWN. METHODS: FROM APRIL 1997 TO MARCH 2010, 674 PATIENTS WITH TYPE B AORTIC DISSECTIONS WERE TREATED PRIMARILY BY THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) AT OUR CENTER. CRITERIA FOR INCLUSION IN THIS STUDY WERE TREATMENT PRIMARILY WITH TEVAR AND AN ESTIMATED MISMATCH RATE (RATIO OF DISTAL DIAMETER OF STENT GRAFT TO LONG DIAMETER OF TRUE LUMEN) GREATER THAN 120%. BY THIS PROTOCOL, 465 PATIENTS WERE INCLUDED IN THIS STUDY AND WERE RETROSPECTIVELY ANALYZED. AMONG THEM, 266 PATIENTS WERE TREATED IN THE ACUTE PHASE, AND 199 WERE T REATED IN THE CHRONIC PHASE. RESULTS: A TOTAL OF 311 PATIENTS WERE TREATED WITH STANDARD TEVAR AND 154 PATIENTS WITH EVARDRESTRICTIVE BARE STENT (RBS). THE PREOPERATIVE MISMATCH RATE (MEASURED AS THE PREOPERATIVE LONG DIAMETER OF THE TRUE LUMEN AT THE LEVEL OF THE INTENDED DISTAL END OF THE STENT GRAFT) OF THE SIDR WAS SIGNIFICANTLY HIGHER THAN THAT OF THE NON-SIDR (192.7 6 54.9% VS 131.9 6 10.4%; P < .05). THE FOLLOW-UP MISMATCH RATE OF THE SIDR WAS SIGNIFICANTLY HIGHER THAN THAT OF THE NON-SIDR (145.4 6 34.6 VS 120.3 6 16.1; P < .05). COMPARED WITH THE STANDARD TEVAR, TEVAR D RBS WAS ASSOCIATED WITH A LOWER INCIDENCE OF SIDR (0% VS 2.9%; P[.033) AND LESS SECONDARY INTERVENTION (3.9% VS 9.3%; P[.040).PLACEMENT OF THE RBS SIGNIFICANTLY EXPANDED THE TRUE LUMEN AT THE LEVEL OF THE DESCENDING AORTA WITH THE NARROWEST TRUE LUMEN AND AT THE LEVEL OF THE DISTAL END OF THE STENT GRAFT. CONCLUSIONS: THE MISMATCH BETWEEN THE DISTAL DIAMETER OF THE STENT GRAFT AND THE DIAMETER OF THE COMPRESSED TRUE LUMEN SEEMS TO BE THE MAJOR FACTOR IN THE OCCURRENCE OF SIDR. PLACEMENT OF AN RBS, AS AN ADJUNCTIVE TECHNIQUE TO TEVAR, COULD REDUCE THE INCIDENCE OF SIDR. ON THE BASIS OF EARLY- TO MIDTERM OBSERVATIONS, RBSS MAY IMPROVE MORPHOLOGICAL REMODELING OF THE DISSECTED AORTA AT CERTAIN LEVELS. (J VASC SURG 2013;57:44S-52S.) IT WAS DOCUMENTED THAT PATIENT (5) HAD AN ONSET OF STENT GRAFT-INDUCED DISTAL RE-DISSECTION 33 MONTHS POST INDEX PROCEDURE, WHICH RESULTED IN A RE-DISSECTION. THE PATIENT WAS TREATED WITH TEVAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316971 VALIANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention