BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX

    MDR report key: 3222999 · Received July 12, 2013

    Report

    Report Number
    2953200-2013-01350
    Event Type
    Death
    Date Received
    July 12, 2013
    Date of Event
    May 28, 2007
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNKNOWN. DATE OF EVENT IS UNKNOWN. (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, RUPTURE, DISSECTION, PARALYSIS, ENDOLEAK, RENAL FAILURE); (UNKNOWN CAUSE OF EVENT); FAILURE TO FOLLOW INSTRUCTIONS (DEVICE USED FOR TREATING A DISSECTION) CONCLUSION: (UNKNOWN CAUSE OF EVENT); KNOWN INHERENT RISK OF A PROCEDURE (DEATH, RUPTURE, DISSECTION, PARALYSIS, ENDOLEAK, RENAL FAILURE); OFF ¿LABEL, UNAPPROVED OR CONTRAINDICATED USE (DEVICE USED FOR TREATING A DISSECTION).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: ENDOVASCULAR GRAFTING OF THE THORACIC AORTA, AN EVOLVING THERAPY: TEN-YEAR EXPERIENCE IN A SINGLE CENTRE DOI: 10.1111/J.1445-2197.20 07.04293 BACKGROUND: SURGICAL THERAPY FOR THE THORACIC AORTA CARRIES A HIGH MORBIDITY AND MORTALITY. ENDOVASCULAR THERAPY FOR ANEURYSMS AND ITS ADAPTATION TO THE THORACIC AORTA OVER THE PAST 10 YEARS IS AN EXCITING ADVANCE. THIS IS A RETROSPECTIVE REVIEW OF ENDOVASCULAR GRAFTING OF THE THORACIC AORTA DURING THE PAST DECADE AT ROYAL PRINCE ALFRED HOSPITAL AND THE OUTCOMES ACHIEVED OVER THIS PERIOD. METHODS: A RETROSPECTIVE REVIEW OF ALL PATIENTS AT OUR INSTITUTION WHO UNDERWENT ENDOVASCULAR GRAFTING OF THE THORACIC AORTA BETWEEN MARCH 1995 AND MARCH 2005 WAS CARRIED OUT. DATA WERE ANALYSED USING STATA VERSION 8.0 (STATA CORPORATION, COLLEGESTATION, TX, USA). RESULTS: SIXTY-FIVE PATIENTS UNDERWENT ENDOVASCULAR STENT GRAFTING OF THE THORACIC AORTA. THE INDICATIONS WERE DEGENERATIVE ANEURYSM (31), STANFORD TYPE B DISSECTION (23) BOTH ACUTE(12) AND CHRONIC (11), TRAUMATIC TRANSECTION (9) AND PENETRATING ULCER (2). THERE WERE NO CONVERSIONS TO OPEN REPAIR. TWENTY-TWO PATIENTS REQUIRED ADDITIONAL PROCEDURES, SIX OF WHICH WERE UNPLANNED. THE MEDIAN AGE WAS 65 (RANGE 18¿85), 68% OF PATIENTS WERE MEN. THE MEDIAN PROCEDURE TIME WAS 115 MIN (RANGE 55¿240 MIN). MEAN HOSPITAL STAY WAS 9.8 ¿ 7.3 DAYS AND HIGH DEPENDENCY/INTENSIVE CARE UNIT STAY 1.5 ¿ 3.2 DAYS. THIRTY-DAY MORTALITY WAS 0 IN 41 FOR ELECTIVE CASES (ONE PATIENT (2.5%) DIED 37 DAYS POST-PROCEDURE) AND 12%(3 OF 25) FOR EMERGENCY CASES. COMPLICATIONS OCCURRED IN 20 OF 41 (49%) ELECTIVE CASES AND 14 OF 24 (58%) EMERGENCY CASES WITHIN THE FIRST 30 DAYS. THE MOST FREQUENT MAJOR COMPLICATIONS WERE NEUROLOGICAL INCLUDING PARAPLEGIA (TRANSIENT 2 OF 65, PERMANENT (2 OF 65) AND STROKE (4 OF 65). OTHER COMPLICATIONS INCLUDED ENDOLEAK (12 OF 65), ACUTE RENAL FAILURE (1 OF 65), AND BRACHIAL ARTERY FALSE ANEURYSM (1 OF 65). THE MEAN LENGTH OF FOLLOW UP WAS 22.5 MONTHS (RANGE, 1¿97 MONTHS). SIX PATIENTS REQUIRED FURTHER ENDOVASCULAR PROCEDURES FOR PERSISTENT ENDOLEAK OR ONGOING PERFUSION OF CHRONIC DISSECTION. LATE DEA THS (>30 DAYS) RELATED TO THE ENDOVASCULAR TREATMENT OCCURRED IN TWO PATIENTS (3%). CONCLUSION: ENDOVASCULAR GRAFTING OF THE THORACIC AORTA IS AN EVOLUTION IN THE TREATMENT OF THORACIC AORTIC PATHOLOGY. THE RESULTS OF ELECTIVE ENDOVASCULAR GRAFTS WERE ACCEPTABLE. EMERGENCY PROCEDURES HAD A HIGHER INCIDENCE OF COMPLICATIONS AND DEATH. IMPROVEMENT IN GRAFT TECHNOLOGY, DESIGN AND DEPLOYMENT ARE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322024 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R