BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC UNKNOWN STENT GRAFT

    MDR report key: 3648055 · Received February 26, 2014

    Report

    Report Number
    2953200-2014-00339
    Event Type
    Death
    Date Received
    February 26, 2014
    Date of Event
    October 18, 2013
    Report Date
    January 31, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CO ACTUAL DATE OF DEATH IS UNKNOWN. (B)(4). EVALUATION RESULTS: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVE DISSECTION). INHERENT RISK OF PROCEDURE (RESPIRATORY FAILURE, SEPSIS, PAIN, FISTULA, BLOOD LOSS, ANEURYSM GROWTH, DEATH). FAILURE TO FOLLOW INSTRUCTIONS (IMPLANTING IN AORTIC ARCH). UNAPPROVED USE OF DEVICE (PRE-OPERATIVE DISSECTION). (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN). EVALUATION CONCLUSIONS: DEVICE FAILURE RELATED TO PATIENT CONDITION (PRE-OPERATIVE DISSECTION). FAILURE TO FOLLOW INSTRUCTIONS (IMPLANTING IN AORTIC ARCH). OFF ¿LABEL, UNAPPROVED OR CONTRAINDICATED USE (PRE-OPERATIVE DISSECTION). KNOWN INHERENT RISK OF A PROCEDURE (RESPIRATORY FAILURE, SEPSIS, PAIN, FISTULA, BLOOD LOSS, ANEURYSM GROWTH, DEATH). (INSUFFICIENT INFORMATION; CAUSE IS UNKNOWN).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. REPAIR OF RETROGRADE ASCENDING DISSECTION AFTER DESCENDING STENT GRAFTING. IDREES J, ARAFAT A, JOHNSTON DR, SVENSSON LG, ROSELLI EE. (J THORAC CARDIOVASC SURG. 2014 JAN;147(1):151-4). DOI: 10.1016/J.JTCVS.2013.08.075 THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: BLOOD LOSS, RESPIRATORY FAILURE, ANEURYSM GROWTH, AORTOBRONCHIAL FISTULA, SEPSIS, DEATH, RETROGRADE DISSECTION WITH ENTRY TEAR IN THE GREATER CURVATURE OF THE AORTIC ARCH, CHEST/BACK PAIN. NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVE: RETROGRADE DISSECTION IS NOW RECOGNIZED AS AN IMPORTANT COMPLICATION AFTER THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR), BUT ITS TREATMENT IS POORLY UNDERSTOOD. OUR OBJECTIVES WERE TO INVESTIGATE THE RISKS, DESCRIBE THE REPAIR METHODS, AND ASSESS THE OUTCOMES OF THIS COMPLICATION. METHODS: FROM 2000 TO 2012, 766 PATIENTS UNDERWENT TEVAR. OF THESE PATIENTS, 14 (1.8%), PLUS 1 WHO HAD UNDERGONE TEVAR ELSEWHERE (N = 15), DEVELOPED RETROGRADE DISSECTION AFTER STENT GRAFTING. THEY HAD UNDERGONE TEVAR FOR DISTAL AORTIC DISSECTION IN 7, INTRAMURAL HEMATOMA IN 5, ANEURYSM IN 2, AND TRANSECTION IN 1. THEIR MEAN AGE WAS 65 ± 9 YEARS. AT THE INITIAL TEVAR, THE LEFT SUBCLAVIAN ARTERY WAS COVERED IN 9, THE MEAN STENT GRAFT DIAMETER WAS 34 ± 2 MM, AND >1 DEVICE WAS USED IN 8 PATIENTS. THE SITE OF ENTRY TEAR WAS AT THE GREATER CURVATURE IN 11 AND LESSER CURVATURE IN 4. ONE PATIENT RUPTURED AND DIED 12 DAYS AFTER TEVAR AND NEVER MADE IT TO THE OPERATING ROOM. THE OTHER 14 UNDERWENT PROXIMAL AORTIC REPAIR. THE MEDIAN INTERVAL BETWEEN TEVAR AND REPAIR OF RETROGRADE DISSECTION WAS 6 MONTHS; 3 PATIENTS PRESENTED WITHIN 1 MONTH. THE REPAIR TECHNIQUES INCLUDED REVERSE FROZEN ELEPHANT TRUNK IN 5, TOTAL ARCH REPAIR IN 4, ASCENDING OR HEMIARCH REPAIR IN 4, AND ASCENDING TEVAR IN 1. CONCOMITANT PROCEDURES INCLUDED AORTIC VALVE REPAIR IN 4, REPLACEMENT IN 2, ROOT REMODELING IN 1, AND CORONARY BYPASS IN 1. RESULTS: NO OPERATIVE MORTALITY OCCURRED. ONE PATIENT UNDERWENT REOPERATION FOR BLEEDING. TWO REQUIRED A TRACHEOSTOMY FOR RESPIRATORY FAILURE. HOWEVER, NO RENAL FAILURE, STROKE, OR SPINAL INJURY OCCURRED. AT A MEDIAN FOLLOW-UP OF 26 MONTHS, 4 AORTIC REOPERATIONS HAD OCCURRED: 1 DISTAL STENT GRAFT EXTENSION FOR TYPE 1B ENDOLEAK, 2 HYBRID THORACOABDOMINAL COMPLETION REPAIRS FOR GROWTH OF RESIDUAL DISTAL DISEASE, AND 1 EMERGENCY TEVAR FOR AORTOBRONCHIAL FISTULA. THE LATTER PATIENT DIED OF SEPTIC COMPLICATIONS, AND 3 OTHER LATE NONCARDIAC DEATHS OCCURRED. CONCLUSIONS: RETROGRADE ASCENDING DISSECTION CAN PRESENT AS AN EARLY OR A LATE COMPLICATION AFTER DESCENDING STENT GRAFTING BECAUSE OF AORTIC INSTABILITY OR DISEASE PROGRESSION AND HAS USUALLY BEEN ASSOCIATED WITH DESCENDING DISSECTION OR INTRAMURAL HEMATOMA. IT IS A LIFE-THREATENING COMPLICATION THAT CAN BE MANAGED SAFELY WITH EARLY RECOGNITION AND RAPID DELIVERY OF OPEN OR HYBRID REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118208 MEDTRONIC UNKNOWN STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R