BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 5648415 · Received May 11, 2016

    Report

    Report Number
    2953200-2016-00990
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    February 23, 2003
    Report Date
    April 26, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATES OF THE EVENTS ARE UNKNOWN.

    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; MORPHOLOGIC CHANGES AND OUTCOME FOLLOWING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR AS A FUNCTION OF ANEURYSM SIZE. FRANK R. ARKO, MD; KONSTANTINO A. FILIS, MD; BRADLEY B. HILL, MD; THOMAS J. FOGARTY, MD; CHRISTOPHER K. ZARINS, MD (ARCH SURG. 2003; 138:651-656) AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ANEURX STENT GRAFT WAS INACCURATELY DELIVERED THAT IT WAS IMPLANTED TOO LOW DUE TO PATIENT'S ANGULATED AORTIC NECK. AFTER THE INDEX PROCEDURE, THE ANEURYSM SIZE WAS DECREASING; HOWEVER, THE PROXIMAL STENT GRAFT FIXATION WAS POOR. THE PATIENT REFUSED SECONDARY INTERVENTION AND HAD A CONTAINED RUPTURE. APPROXIMATELY 22 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT UNDERWENT SUCCESSFUL OPEN REPAIR WITHOUT ANY COMPLICATIONS . NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. HYPOTHESIS&#2067;MALL INFRARENAL ABDOMINAL AORTIC ANEURYSMS HAVE A MORE FAVORABLE CLINICAL AND MORPHOLOGIC OUTCOME COMPARED WITH MEDIUM AND LARGE ABDOMINAL AORTIC ANEURYSMS FOLLOWING ENDOVASCULAR ANEURYSM REPAIR(EVAR). DESIGN&#2049; PROSPECTIVE CLINICAL SERIES OF 206 PATIENTS UNDERGOING ELECTIVE EVAR BETWEEN 1996 AND 2001. SETTING A TERTIARY CARE ACADEMIC HEALTH CENTER. PATIENTS WERE GROUPED ACCORDING TO ANEURYSM SIZE: SMALL (<(> <<)>50 MM), MEDIUM (50-60 MM), AND LARGE (>60 MM). INTERVENTIONS PRIMARY EVAR AND SECONDARY PROCEDURES TO SECURE FIXATION OF THE STENT GRAFT AND SURGICAL CONVERSIONS. MAIN OUTCOME MEASURES ANEURYSM DIAMETER, ENDOLEAKS, AND LONG-TERM MORPHOLOGIC CHANGES WERE ANALYZED POSTOPERATIVELY WITH 3-DIMENSIONAL RECONSTRUCTIONS OF COMPUTED TOMOGRAPHIC ANGIOGRAMS. RESULTS GROUPS WERE SIMILAR IN AGE, COMORBIDITIES, AND FOLLOW-UP (MEAN ± SD, 32.1 ± 11.8 MONTHS). THERE WERE 30 SMALL ANEURYSMS, 92 MEDIUM ANEURYSMS, AND 84 LARGE ANEURYSMS, WITH A MEAN SIZE OF 45.1 ± 3.7 MM, 53.8 ± 3.1 MM, AND 66.1 ± 6.8 MM, RESPECTIVELY (P<(><<)>.01). THERE WAS NO SIGNIFICANT DIFFERENCE IN PROXIMAL NECK OR ILIAC ARTERY DIAMETER AMONG THE 3 GROUPS. THE PROXIMAL AORTIC NECK LENGTH (28.1 ± 11.6 MM [SMALL]; 23.9 ± 11.3 MM [MEDIUM]; AND 22.1 ± 11.6 MM [LARGE]; P<(> <<)>.05) WAS SIGNIFICANTLY SHORTER IN LARGE ANEURYSMS. FURTHERMORE, THERE WAS A SIGNIFICANT INCREASE (6% [SMALL]; 15% [MEDIUM]; AND 21% [LARGE]; P<(><<)>.05) IN ANGULATED NECKS IN LARGE ANEURYSMS. FOLLOWING TREATMENT, ANEURYSM DIAMETER REMAINED STABLE IN MOST PATIENTS (83% [SMALL]; 82% [MEDIUM]; AND 83% [LARGE]), WITH A MEAN DECREASE OF 2.0 ± 6.5 MM, 2.1 ± 6.1 MM, AND 3.7 ± 7.7 MM IN EACH GROUP, RESPECTIVELY (P = .45). THERE WAS NO DIFFERENCE IN THE INCIDENCE OF ENDOLEAKS, ANEURYSM CONTRACTION, OR ANEURYSM EXPANSION BASED ON PREOPERATIVE ANEURYSM DIAMETER. SECONDARY PROCEDURES WERE PERFORMED IN 5 (20%) OF 25, 9 (5.2%) OF 170, AND 5 (36%) OF 11 ANEURYSMS THAT CONTRACTED, REMAINED STABLE, OR EXPANDED, RESPECTIVELY, FOLLOWING EVAR (P<(><<)>.05). CONCLUSIONS THERE IS A 15% INCREASE IN NECK ANGULATION AND A 27% DECREASE IN NECK LENGTH IN LARGE COMPARED WITH SMALL INFRARENAL ABDOMINAL AORTIC ANEURYSMS, WITH NO DIFFERENCE IN OUTCOME. ANEURYSMS THAT ARE STABLE FOLLOWING EVAR HAVE A SIGNIFICANTLY LOWER INCIDENCE OF REQUIRING SECONDARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301091 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention