BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC STENT GRAFT

    MDR report key: 3821606 · Received May 20, 2014

    Report

    Report Number
    2953200-2014-01038
    Event Type
    Death
    Date Received
    May 20, 2014
    Date of Event
    January 7, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. A LIMITED AND CUSTOMIZED FOLLOW-UP SEEMS JUSTIFIED AFTER ENDOVASCULAR ABDOMINAL ANEURYSM REPAIR IN OCTOGENARIANS. LINDA VISSER, ROBERT A. POL, IGNACE F. J. TIELLIU, JAN J. A. M. VAN DEN DUNGEN, AND CLARK J. ZEEBREGTS. (J VASC SURG 2014;59:1232-40.) THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DISTAL TYPE I ENDOLEAK, TYPE II ENDOLEAK, PROXIMAL TYPE I ENDOLEAK, TYPE II ENDOLEAK, DEATH, BYPASS, OCCLUSION, ANEURYSM GROWTH, MIGRATION, KINKING, POST-OP RUPTURE, CONVERSION TO OPEN REPAIR, INFECTION. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVE: THE OBJECTIVE OF THIS STUDY WAS TO DETERMINE WHETHER LONG-TERM FOLLOW-UP AFTER ENDOVASCULAR ANEURYSM REPAIR (EVAR) IS JUSTIFIED IN OCTOGENARIANS. METHODS: BETWEEN SEPTEMBER 1996 AND OCTOBER 2011, ALL PATIENTS, INCLUDING OCTOGENARIANS, TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) BY EVAR WERE INCLUDED IN A PROSPECTIVE DATABASE. PATIENTS OLDER THAN 80 YEARS AND WITH A NONRUPTURED INFRARENAL ANEURYSM TREATED ELECTIVELY OR URGENTLY WERE INCLUDED IN THE STUDY (STUDY GROUP [SG]). PATIENTS WITH RUPTURED ANEURYSMS AND PATIENTS WHO DIED DURING SURGERY OR WITHIN THE FIRST POSTOPERATIVE MONTH WERE EXCLUDED FROM FURTHER ANALYSIS. THE CONTROL GROUP (CG) CONSISTED OF PATIENTS YOUNGER THAN 80 YEARS, MATCHED FOR GENDER AND AAA DIAMETER. ALL PATIENTS WERE EVALUATED 4 TO 8 WEEKS AFTER EVAR AND THEN ANNUALLY THEREAFTER. FOLLOW-UP DATA WERE COMPLEMENTED BY REVIEW OF THE COMPUTERIZED HOSPITAL REGISTRY AND CHARTS AND BY CONTACT OF THE PATIENT¿S GENERAL PRACTITIONER OR REFERRING HOSPITAL. PRIMARY OUTCOMES WERE STENT- OR ANEURYSM-RELATED COMPLICATIONS AND INTERVENTIONS. SECONDARY OUTCOMES WERE ADDITIONAL SURGICAL COMPLICATIONS AND PATIENT SURVIVAL. RESULTS: A TOTAL NUMBER OF 193 PATIENTS (SG, N [ 97; CG, N [ 96) WERE INCLUDED FOR ANALYSIS. MEDIAN AGE WAS 80 YEARS, AND 88.6% WERE MALE. MEDIAN FOLLOW-UP TIME WAS 33.6 MONTHS (INTERQUARTILE RANGE [IQR], 12.9-68.3). STENT- AND PROCEDURE-RELATED POSTOPERATIVE COMPLICATIONS WERE COMPARABLE BETWEEN GROUPS (SG, 41.2%; CG, 39.6%; P [ .82). MEDIAN TIME TO COMPLICATION WAS 2.3 MONTHS (IQR, 0.2-19.4) IN THE SG COMPARED WITH 18.1 MONTHS (IQR, 6.8-50.5) IN THE CG. THE 2-YEAR COMPLICATION-FREE SURVIVAL RATES WERE 58% (SG) AND 60% (CG). INTERVENTIONS WERE PERFORMED SIGNIFICANTLY LESS FREQUENTLY IN OCTOGENARIANS (SG, 8.2%; CG, 19.8%; P <(><<)> .05). MEDIAN TIME TO INTERVENTION WAS 11.1 MONTHS (IQR, 2.0-31.0) IN THE SG COMPARED WITH 54.3 MONTHS (IQR, 15.0-93.2) IN THE CG. THE 2-YEAR INTERVENTION-FREE SURVIVAL RATES WERE 90% (SG) AND 92% (CG). DURING FOLLOW-UP, 98 PATIENTS DIED (SG, N [ 54; CG, N [ 44); MEDIAN TIME TO DEATH WAS 31.8 MONTHS (IQR, 13.3-66.0) IN THE SG COMPARED WITH 44.4 MONTHS (IQR, 15.0- 77.7) IN THE CG. ONE ANEURYSM-RELATED DEATH OCCURRED IN THE CG. THE 2- AND 5-YEAR SURVIVAL RATES WERE 71% AND 32% FOR THE SG COMPARED WITH 77% AND 66% FOR THE CG (P <(><<)> .05). CONCLUSIONS: BECAUSE OF THE LOW INCIDENCE OF SECONDARY PROCEDURES AND AAA-RELATED DEATHS IN OCTOGENARIANS, LONG-TERM AND FREQUENT FOLLOW-UP AFTER EVAR SEEMS QUESTIONABLE. AN ADAPTED AND SHORTENED FOLLOW-UP SEEMS WARRANTED IN THIS PATIENT GROUP. (J VASC SURG 2014;59:1232-40.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299930 MEDTRONIC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death| R