BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2267808 · Received September 23, 2011

    Report

    Report Number
    2953200-2011-01657
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    April 24, 2004
    Report Date
    August 25, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: SPINAL CORD ISCHEMIA, DEATH. TYPE II ENDOLEAK. EVAL, CONCLUSIONS: TYPE II ENDOLEAK.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFO IN A JOURNAL ARTICLE (TITLE: RISK FACTORS, OUTCOMES, AND CLINICAL MANIFESTATIONS OF SPINAL CORD ISCHEMIA (SCI) FOLLOWING THORACIC ENDOVASCULAR AORTIC REPAIR; SOCIETY FOR VASCULAR SURGERY: J.JVS.2011 03.259). TALENT THORACIC STENT GRAFTS WERE IMPLANTED IN PTS FOR THE ENDOVASCULAR TREATMENT OF THORACIC ANEURYSM REPAIR. THE JOURNAL ARTICLE PRESENTED. THE NUMBER OF DEVICES USED AND LOT NUMBERS ARE UNK. THE STUDY WAS CONDUCTED FOR TEVAR OCCURRING BETWEEN NINE YRS AGO AND ONE YR AGO, AND INVOLVED 424 PTS. DEVICES STUDIED WERE FROM MEDTRONIC AND THREE OTHER MFRS. METHODS: A RETROSPECTIVE REVIEW OF A PROSPECTIVELY COLLECTED DATABASE WAS PERFORMED FOR ALL PTS UNDERGOING THORACIC REPAIR (TEVAR) AT A SINGLE ACADEMIC INSTITUTION. PREOPERATIVE DEMOGRAPHICS, PROCEDURE-RELATED VARIABLES, AND CLINICAL DETAILS RELATED TO SCI WERE EXAMINED. LOGISTIC REGRESSION ANALYSIS WAS PERFORMED TO IDENTIFY RISK FACTORS FOR THE DEVELOPMENT OF SCI. RESULTS: OF THE 424 PTS WHO UNDERWENT TEVAR DURING THE STUDY PERIOD, 12 PTS (2.8%) DEVELOPED SCI. THERE WERE 2 LATE DEATHS AFTER EVAR IN THE SCI GROUP. TWO PTS HAD EVIDENCE OF TYPE II ENDOLEAKS AND NONE REQUIRED SECONDARY INTERVENTION. MEAN AGE OF THIS COHORT WITH SCI WAS (B)(6), AND 7 WERE WOMEN. ONE-HALF OF THESE PTS HAD PRIOR OPEN OR ENDOVASCULAR AORTIC REPAIR. INDICATION FOR SURGERY WAS EITHER DEGENERATIVE ANEURYSM (N=8) OR DISSECTION (N=4). SIX TEVARS WERE PERFORMED ELECTIVELY, WITH THE REMAINING DONE EITHER URGENTLY OR EMERGENTLY DUE TO CONTAINED RUPTURE (N=2), DISSECTION WITH MALPERFUSION (N=2), OR SEVERE BACK PAIN (N=2). ALL 12 PTS UNDERWENT EXTENT C ENDOVASCULAR COVERAGE. MULTIVARIATE REGRESSION ANALYSIS DEMONSTRATED CHRONIC RENAL INSUFFICIENCY TO BE INDEPENDENTLY ASSOCIATED WITH SCI (ODDS RATIO [OR], 4.39; 95% CONFIDENCE INTERVAL [C], 1.2-16.6; P=.029). ONSET OF SCI OCCURRED AT A MEDIAN OF 10.6 HRS (RANGE, 0-229 HRS) POST PROCEDURE AND WAS DELAYED IN 83% (N=10) OF PTS. CLINICAL MANIFESTATIONS OF SCI INCLUDED LOWER EXTREMITY PARAPARESIS IN 9 PTS AND PARAPLEGIA IN 3 PTS. AT SCI ON SET, AVERAGE MEAN ARTERIAL PRESSURE (MAP) AND LUMBAR CEREBROSPINAL FLUID (CSF) PRESSURE WAS 77 MM HG AND 10 MM HG, RESPECTIVELY. THERAPEUTIC INTERVENTIONS INCREASED BLOOD PRESSURE TO A SIGNIFICANTLY HIGHER AVERAGE MAP OF 99 MMHG (P=.001) AND DECREASED LUMBAR CSF PRESSURE TO A MEAN OF 7 MM HG (P=30) AT THE TIME OF NEUROLOGIC RECOVERY. THIRTY-DAY MORTALITY WAS 8% (1 OF 12 PTS). THE SINGLE PT, WHO EXPIRED, NEVER RECOVERED ANY LOWER EXTREMITY NEUROLOGIC FUNCTION. ALL PTS SURVIVING TO DISCHARGE EXPERIENCED EITHER COMPLETE (N=9) OR INCOMPLETE (N=2) NEUROLOGIC RECOVERY. AT MEAN F/U OF 49 MONTHS, 7 OF 9 PTS CURRENTLY ALIVE CONTINUED TO EXHIBIT COMPLETE, SUSTAINED NEUROLOGIC RECOVERY. CONCLUSION: SPINAL CORD ISCHEMIA AFTER TEVAR IS AN UNCOMMON, BUT IMPORTANT COMPLICATION. PREOPERATIVE RENAL INSUFFICIENCY WAS IDENTIFIED AS A RISK FACTOR FOR THE DEVELOPMENT OF SCI. EARLY DETECTION AND TREATMENT OF SCI WITH BLOOD PRESSURE AUGMENTATION ALONE OR IN COMBINATION WITH CSF DRAINAGE WAS EFFECTIVE IN MOST PTS, WITH THE MAJORITY ACHIEVING COMPLETE, LONG-TERM NEUROLOGIC RECOVERY. (J VASC SURG 2011.03.259). THE AUTHOR HAS BEEN CONTACTED AND FURTHER INFO HAS BEEN REQUESTED. THIS EVENT DOES NOT MATCH PREVIOUS EVENTS REPORTED TO MEDTRONIC. REF: MFR REPORT# 2953200-2011-0XXXX, 2953200-2011-0XXXX, 2953200-2011-0XXXX, 2953200-2011-0XXXX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 52735

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention