BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 5654115 · Received May 13, 2016

    Report

    Report Number
    2953200-2016-01020
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    May 16, 2002
    Report Date
    April 28, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE EXACT DATES OF THE EVENTS ARE UNKNOWN. 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

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ANEURYSM NECK DIAMETER AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS MOHAMMAD F. BADRAN, MD, DEREK A. GOULD, MD, IRFAN RAZA, RICHARD G. MCWILLIAMS, MD, OLIVER BROWN, BA, PETER L. HARRIS, MD, GEOFFREY L. GILLING-SMITH, MD, JOHN BRENNAN, MD, DONNA WHITE, DCR(R), SHAUN MEAKIN, SRN, AND PETER C. ROWLANDS, MD (J VASC INTERV RADIOL 2002; 13:887¿892) ANEURX AND TALENT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA ENDOLEAK, OPEN REPAIR. PURPOSE: TO DETERMINE ANEURYSM NECK DIAMETER CHANGE AFTER ENDOVASCULAR REPAIR (EVR) OF ABDOMINAL AORTIC ANEURYSM (AAA) AND ITS RELATIONSHIP TO STENT-GRAFT DIAMETER. MATERIALS AND METHODS: THE CASES OF 73 PATIENTS WITH AAAS WHO UNDERWENT EVR WERE REVIEWED RETROSPECTIVELY: 68 HAD PREOPERATIVE IMAGING AVAILABLE. NECK DIAMETER WAS REVIEWED BY A SINGLE OBSERVER (M.F.B.) ON PREOPERATIVE, IMMEDIATE POSTOPERATIVE, ANNUAL, AND MOST RECENT CONTRAST-ENHANCED COMPUTED TOMOGRAPHIC SCANS. BASELINE AND FOLLOW-UP NECK DIAMETERS WERE COMPARED WITH THE MANUFACTURERS¿ VALUES FOR UNCONSTRAINED STENT-GRAFT DIAMETERS. RESULTS: INTRAOBSERVER ERROR WAS 2 MM. ANEURYSM NECK DIAMETER INCREASED FROM 21.8 MM (RANGE, 17¿28 MM) AT BASELINE TO 22.8 MM (RANGE, 19¿30 MM) POSTOPERATIVELY AND 25.8 MM (RANGE, 19¿31 MM; P <(><<)> .001) AT A MEAN FOLLOW-UP OF 25.5 MONTHS (RANGE, 6.2¿ 60.8 MO). NECK DIAMETER INCREASE WAS MORE THAN 2 MM IN 24 PATIENTS (33%). MEAN CHANGE IN THE FIRST, SECOND, THIRD, AND FOURTH YEARS WAS 1.63 MM, 0.52 MM, 0.25 MM, AND 0.33 MM, RESPECTIVELY. BASELINE MEAN STENT-GRAFT OVERSIZING WAS 2.9 MM (13.7%; RANGE, - 1 TO 8 MM), WHICH DECREASED TO 0.7 MM (RANGE, - 4 TO 6 MM) AT LATEST FOLLOW-UP. NECK DIAMETER EXCEEDED STENT-GRAFT DIAMETER (MEAN, 1.8 MM; RANGE, 1¿4 MM) IN 21 CASES (28%) AND BY MORE THAN 2 MMIN FIVE CASES (6.8%). WHEN NECK DIAMETER CHANGE WAS CORRELATED WITH CHANGE IN SAC DIAMETER, IT WAS FOUND TO BE INSIGNIFICANT (P = .24); HOWEVER, IT WAS SIGNIFICANTLY CORRELATED WITH BASELINE OVERSIZING (P = .01). CONCLUSIONS: AFTER EVR, THE ANEURYSM NECK DILATES, MOSTLY IN THE FIRST 2 YEARS, BY GREATER THAN 2 MM IN ONE THIRD OF PATIENTS. THIS IS POSSIBLY RELATED TO THE PRESENCE OF THE ENDOGRAFT. THE ASSOCIATED REDUCTION OF STENT-GRAFT OVERSIZING WARRANTS CONTINUED VIGILANCE FOR PROXIMAL ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309512 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention