BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT CAPTIVIA STENT GRAFT

    MDR report key: 8636439 · Received May 23, 2019

    Report

    Report Number
    9612164-2019-01926
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    November 13, 2018
    Report Date
    June 26, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: AS PER THE PHYSICIAN, NONE OF THE 15 PATIENTS TREATED WITH MEDTRONIC DEVICES HAD A PERI-OPERATIVE ADVERSE EVENT WITHIN 30 DAYS OF IMPLANT THAT COULD BE SPECIFICALLY RELATED TO THE DEVICE ITSELF. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED: "COVERAGE OF VISIBLE INTERCOSTAL AND LUMBAR SEGMENTAL ARTERIES CAN PREDICT THE VOLUME OF CEREBROSPINAL FLUID DRAINAGE IN ELECTIVE ENDOVASCULAR REPAIR OF DESCENDING THORACIC AND THORACOABDOMINAL AORTIC DISEASE: A PILOT STUDY." MARIO D¿ORIA, STEFANO CHIARANDINI, MARCO PIPITONE, CRISTIANO CALVAGNA AND BARBARA ZIANI. EUR J CARDIOTHORAC SURG DOI: :10.1093/EJCTS/EZY371. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR REPAIR OF DESCENDING THORACIC OR THORACOABDOMINAL AORTIC DISEASE. THE FOLLOWING EVENTS WERE REPORTED: HYPOTENSION CEREBROSPINAL FLUID LEAKAGE SPINAL HEADACHE ABSTRACT OBJECTIVES OUR GOAL WAS TO IDENTIFY ANATOMICAL AND PHYSIOLOGICAL FACTORS THAT COULD PREDICT THE AMOUNT OF CEREBROSPINAL FLUID (CSF) DRAINAGE IN PATIENTS UNDERGOING ELECTIVE ENDOVASCULAR REPAIR OF DESCENDING THORACIC AND THORACOABDOMINAL AORTIC DISEASE. METHODS ALL CONSECUTIVE ELECTIVE ENDOVASCULAR PROCEDURES PERFORMED FOR DESCENDING THORACIC OR THORACOABDOMINAL AORTIC DISEASE BETWEEN JANUARY 2015 AND DECEMBER 2017 WERE INCLUDED IN THE STUDY. ROUTINE USE OF CSF DRAINAGE WAS ESTABLISHED IN ALL PATIENTS. THE GOAL OF DRAINAGE WAS TO REACH A SPINAL FLUID PRESSURE OF 10¿12¿MMHG BY DRAINING IN 5¿15-ML ALIQUOTS. THE NUMBER OF VISIBLE INTERCOSTAL AND LUMBAR SEGMENTAL ARTERIES (SAS) WAS EVALUATED BEFORE AND AFTER ENDOVASCULAR REPAIR. THE COVERING RATIO OF SAS WAS CALCULATED AS COVERED PREOPERATIVE SAS/TOTAL PREOPERATIVE SAS. RESULTS TWENTY-FOUR CONSECUTIVE PATIENTS WERE INCLUDED IN THE FINAL ANALYSIS. THE INDICATION FOR THE INTERVENTION WAS A DESCENDING THORACIC ANEURYSM IN 13 CASES, A THORACOABDOMINAL ANEURYSM IN 4 CASES AND A CHRONIC TYPE B DISSECTION IN 7 CASES. THE PROCEDURE PERFORMED WAS THORACIC ENDOVASCULAR AORTIC REPAIR IN 20 CASES AND FENESTRATED ENDOVASCULAR ANEURYSM REPAIR IN 4 CASES. NONE OF THE PATIENTS DEVELOPED SPINAL CORD ISCHAEMIA. THE MEAN VOLUME OF CSF DRAINED WAS 46¿ML. THE MEAN LENGTH OF AORTIC COVERAGE WAS 231¿MM. THE MEAN NUMBER OF TOTAL PREOPERATIVE SAS AND OF COVERED PREOPERATIVE SAS WAS, RESPECTIVELY, 22 AND 9. THE VOLUME OF CSF DRAINED WAS SIGNIFICANTLY CORRELATED WITH ALL THESE VARIABLES (LENGTH OF AORTIC COVERAGE, TOTAL VISIBLE SAS AND COVERED SAS), BUT THE MOST POWERFUL CORRELATION WAS INDIVIDUATED WITH THE COVERING RATIO OF SAS. CONCLUSIONS OUR FINDINGS SUGGEST THAT THE PERCENTAGE OF INTERCOSTAL AND LUMBAR SAS COVERED BY PLACEMENT OF A STENT GRAFT CAN PREDICT THE VOLUME OF CSF DRAINED IN PATIENTS UNDERGOING ELECTIVE ENDOVASCULAR REPAIR OF DESCENDING THORACIC AND THORACOABDOMINAL AORTIC DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428895 VALIANT CAPTIVIA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention