BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX

    MDR report key: 3211100 · Received July 8, 2013

    Report

    Report Number
    2953200-2013-01273
    Event Type
    Death
    Date Received
    July 8, 2013
    Date of Event
    December 1, 2007
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 (INFECTION, MIGRATION, ENDOLEAK, DEATH, OCCLUSION, RENAL FAILURE, DISSECTION, RUPTURE, PARALYSIS); (UNKNOWN CAUSE OF EVENT); FAILURE TO FOLLOW INSTRUCTIONS (TREATING A MYCOTIC ANEURYSM, DEPLOYING IN THE ASCENDING ARCH). CONCLUSION: (UNKNOWN CAUSE OF EVENT) 24 OFF ¿LABEL, UNAPPROVED OR CONTRAINDICATED USE (TREATING A MYCOTIC ANEURYSM, DEPLOYING IN THE ASCENDING ARCH); KNOWN INHERENT RISK OF A PROCEDURE (INFECTION, MIGRATION, ENDOLEAK, DEATH, OCCLUSION, RENAL FAILURE, DISSECTION, RUPTURE, PARALYSIS).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: NEUROLOGIC COMPLICATIONS ASSOCIATED WITH ENDOVASCULAR REPAIR OF THORACIC AORTIC PATHOLOGY: INCIDENCE AND RISK FACTORS. A STUDY FROM THE EUROPEAN COLLABORATORS ON STENT/GRAFT TECHNIQUES FOR AORTIC ANEURYSM REPAIR (EUROSTAR) REGISTRY. JACOB BUTH, MD, PETER L. HARRIS, MD, ROEL HOBO, MS, RANDOLPH VAN EPS, MD, PHILIPPE CUYPERS, MD, LUCIEN DUIJM, MD AND XANDER TIELBEEK, MD, EINDHOVEN, THE NETHERLANDS; AND LIVERPOOL, UNITED KINGDOM ( J VASC SURG 2007;46:1103-11.) ON AN UNKNOWN DATE BETWEEN JULY 2000 AND JULY 2006, AN UNKNOWN ANEURX STENT GRAFT, AN UNKNOWN TALENT STENT GRAFT AND AN UNKNOWN VALIANT STENT GRAFT WERE IMPLANTED. DURING A RETROSPECTIVE STUDY OF 606 PATIENTS TREATED FOR ENDOVASCULAR REPAIR, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: STENT GRAFT INFECTION, STROKE, PARAPLEGIA, PRE-OP DISSECTION, DISSECTION, POST-OP RUPTURE, SPINAL CORD ISCHEMIA, RENAL FAILURE, UNKNOWN ENDOLEAK, ACUTE DEATH, CHRONIC DEATH, SURGICAL CONVERSION, MIGRATION, ANEURYSM EXPANSION, THROMBOSIS . NO FURTHER INFORMATION IS AVAILABLE FOR THIS EVENT. OBJECTIVE: ENDOVASCULAR TREATMENT OF THORACIC AORTIC DISEASE MAY BE ASSOCIATED WITH SEVERE NEUROLOGIC COMPLICATIONS. THE CURRENT STUDY USED THE DATA OF A MULTICENTER REGISTRY TO ASSESS OF THE INCIDENCE AND THE RISK FACTORS FOR PARAPLEGIA OR PARAPARESIS AND INTRACRANIAL STROKE. METHODS: THE EUROPEAN COLLABORATORS ON STENT/GRAFT TECHNIQUES FOR AORTIC ANEURYSM REPAIR (EUROSTAR) DATABASE PROSPECTIVELY ENROLLED 606 PATIENTS. THORACIC PATHOLOGIES WITH URGENT OR ELECTIVE PRESENTATION, WHICH INCLUDED DEGENERATIVE ANEURYSM IN 291, AORTIC DISSECTION IN 215, TRAUMATIC RUPTURE IN 67, ANASTOMOTIC FALSE ANEURYSM IN 24, AND INFECTIOUS OR NONSPECIFIED DISORDERS IN 9. STUDY END POINTS INCLUDED EVIDENCE OF PERIOPERATIVE SPINAL CORD ISCHEMIA (SCI) OR STROKE. UNIVARIATE ANALYSIS AND MULTIVARIATE REGRESSION MODELS WERE USED TO ASSESS THE SIGNIFICANCE OF CLINICAL FACTORS THAT POTENTIALLY INFLUENCED THE OCCURRENCE OF NEUROLOGICAL SEQUELAE. RESULTS: PARAPLEGIA OR PARAPARESIS DEVELOPED IN 15 PATIENTS (2.5%) AND STROKE IN 19 (3.1%); TWO PATIENTS HAD BOTH COMPLICATIONS. AT MULTIVARIATE REGRESSION ANALYSIS, INDEPENDENT CORRELATION WITH SCI WAS OBSERVED FOR FOUR FACTORS: (1) LEFT SUBCLAVIAN ARTERY COVERING WITHOUT REVASCULARIZATION (ODDS RATIO [OR], 3.9; P =.027), (2) RENAL FAILURE (OR, 3.6; P =.02), (3) CONCOMITANT OPEN ABDOMINAL AORTA SURGERY (OR, 5.5; P = .037) AND (4) THREE OR MORE STENT GRAFTS USED (OR, 3.5; P = .043). IN PATIENTS WITH PERIOPERATIVE STROKE, TWO CORRELATING FACTORS WERE IDENTIFIED: (1) DURATION OF THE INTERVENTION (OR, 6.4; P = .0045) AND (2) FEMALE SEX (OR, 3.3; P =.023). A NEUROLOGIC COMPLICATION (PARAPLEGIA OR STROKE) DEVELOPED IN 8.4% OF THE PATIENTS IN WHOM LEFT SUBCLAVIAN COVERING WAS REQUIRED COMPARED WITH 0% OF PATIENTS WITH PROPHYLACTIC REVASCULARIZATION (P = .049). CONCLUSION: PERIOPERATIVE PARAPLEGIA OR PARAPARESIS WAS SIGNIFICANTLY ASSOCIATED WITH BLOCKAGE OF THE LEFT SUBCLAVIAN ARTERY WITHOUT REVASCULARIZATION. THE CLINICAL SIGNIFICANCE OF THIS SOURCE OF COLLATERAL PERFUSION OF THE SPINAL CORD HAD NOT BEEN CONFIRMED PREVIOUSLY. INTRACRANIAL STROKE WAS ASSOCIATED WITH LENGTHY MANIPULATION OF WIRES, CATHETERS, AND INTRODUCER SHEATHS WITHIN THE AORTIC ARCH, REFLECTED BY A LONGER DURATION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310610 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death