BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELIANT BALLOON

    MDR report key: 3863959 · Received June 10, 2014

    Report

    Report Number
    2953200-2014-01171
    Event Type
    Death
    Date Received
    June 10, 2014
    Date of Event
    March 1, 2009
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSIONS: PRE-OPERATIVE RUPTURE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. TEN YEARS OF EMERGENCY ENDOVASCULAR ANEURYSM REPAIR FOR RUPTURED ABDOMINAL AORTOILIAC ANEURYSMS: LESSONS LEARNED. MAYER D, PFAMMATTER T, RANCIC Z, HECHELHAMMER L, WILHELM M, VEITH FJ, LACHAT M. (ANN SURG. 2009 MAR;249(3):510-5). DOI: 10.1097/SLA.0B013E31819A8B65. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, MI, BLOOD LOSS, HEMORRHAGE, MULTIPLE ORGAN FAILURE, PNEUMONIA, LIVER FAILURE, VT/VF, ABDOMINAL COMPARTMENT SYNDROME, IVC THROMBOSIS, RENAL INFARCTION, LIMB ISCHEMIA, AND EMBOLI. IN ONE PATIENT BALLOON OCCLUSION RESULTED IN EMBOLI INTO VISCERAL ARTERIES, WHICH LED TO DEATH. NO FURTHER INFORMATION IS AVAILABLE FOR THESE EVENTS. OBJECTIVE: TO EVALUATE A SINGLE CENTER'S 10-YEAR EXPERIENCE WITH EMERGENCY ENDOVASCULAR ANEURYSM REPAIR (EEVAR) IN 102 PATIENTS WITH RUPTURED ABDOMINAL AORTOILIAC ANEURYSMS (RAAA). METHODS: DATA FROM 102 PATIENTS (MEAN AGE, 73 +/- 9 YEARS) WITH RAAA TREATED BY EEVAR FROM JANUARY 1998 TO APRIL 2008 WERE RETROSPECTIVELY REVIEWED. FROM JANUARY 2000, ALL PATIENTS WERE TREATED ACCORDING TO AN INTENTION-TO-TREAT PROTOCOL. THE ONLY EXCLUSION CRITERION WAS UNSUITABLE ANATOMY. 31/102 PATIENTS HAD MODERATE SHOCK AND 14/102 PATIENTS HAD SEVERE SHOCK WITH A SYSTOLIC BLOOD PRESSURE <(><<)>70 MM HG OR <(><<)>50 MM HG, RESPECTIVELY. 71/102 PROCEDURES WERE CARRIED OUT UNDER LOCAL ANESTHESIA. ENDOGRAFT TYPES USED WERE MAINLY BIFURCATED (92/102). OPEN ABDOMEN TREATMENT (OAT) BECAUSE OF ABDOMINAL COMPARTMENT SYNDROME (ACS) WAS USED WHEN SIGNS OF ORGAN FAILURE OCCURRED AND/OR BLADDER PRESSURE ROSE >20 MM HG. RESULTS: THE 30-DAY MORTALITY FOR EEVAR WAS 13% (13/102). TECHNICAL SUCCESS (DEFINED AS SUCCESSFUL DEPLOYMENT OF THE ENDOGRAFT, ABSENCE OF EXTRAVASATION IN THE POSTPROCEDURAL CONTRAST ENHANCED CT SCAN AND HEMODYNAMIC STABILIZATION) WAS 99% (101/102). NINETEEN UNSTABLE PATIENTS (19%) REQUIRED TRANSFEMORAL SUPRACELIAC AORTIC BALLOON OCCLUSION. ACS WAS DETECTED AND TREATED BY OAT IN 20 PATIENTS (20%). SIXTEEN TYPE I, 26 TYPE II AND 1 TYPE III ENDOLEAKS WERE DETECTED ON POSTOPERATIVE CT EXAMINATION. TWO PATIENTS HAD A COMBINED TYPE I AND II ENDOLEAK. ELEVEN PATIENTS WERE RETREATED FOR IMMEDIATE CORRECTION OF 10 TYPE I AND 2 TYPE II ENDOLEAKS. SIX TYPE I AND 1 TYPE III LOW-FLOW ENDOLEAKS WERE OBSERVED AND RESOLVED SPONTANEOUSLY WITHIN 30 DAYS. MAJOR 30-DAY MORBIDITY WAS 35%. CONCLUSION: IN THIS 102 PATIENT CONTEMPORARY SERIES OF EEVAR FOR RAAA, ENDOGRAFTING PROVED TO BE SAFE WITH A 30-DAY MORTALITY OF 13%. KEY COMPONENTS OF THIS FAVORABLE OUTCOME RESULT WERE ADEQUATE PREOPERATIVE DIAGNOSTIC IMAGING, HYPOTENSIVE HEMOSTASIS, SELECTIVE TRANSFEMORAL SUPRACELIAC AORTIC BALLOON OCCLUSION, PREDOMINANTLY LOCAL ANESTHESIA, DETECTION AND TREATMENT OF ACS, AND ATTENTION TO LOGISTICS. WIDESPREAD ADOPTION OF THESE TREATMENT COMPONENTS IS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340916 RELIANT BALLOON CATHETER, PERCUTANEOUS DQY MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death| R