BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT AAA STENT GRAFT SYSTEM

    MDR report key: 2853149 · Received November 30, 2012

    Report

    Report Number
    2953200-2012-02302
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (RENAL FAILURE, OCCLUSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED: RENAL ARTERY STENOSIS); INCORRECT TECHNIQUE/PROCEDURE (INACCURATE PLACEMENT OF DEVICE). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED: RENAL ARTERY STENOSIS); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (INACCURATE PLACEMENT OF DEVICE).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: STRATEGIES TO TACKLE UNRECOGNIZED BILATERAL RENAL ARTERY OCCLUSION AFTER ENDOVASCULAR ANEURYSM REPAIR, JOHN ADU, NICHOLAS J. CHESHIRE, CELIA V. RIGA, MOHAMAD HAMADY, AND COLIN D. BICKNELL, LONDON, UNITED KINGDOM. BACKGROUND: UNINTENTIONAL RENAL ARTERY OCCLUSION AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) IS AN UNCOMMON PHENOMENON. THE SEQUELAE FROM THIS SPECIFIC COMPLICATION ARE SEVERE; CONSEQUENTLY, THE TOPIC OF RENAL ARTERY COVERAGE IS A PERTINENT ISSUE. WE PRESENT A CASE SERIES OF PATIENTS UNDERGOING EVAR WITH UNINTENTIONAL RENAL ARTERY COVERAGE, REVIEW THE TREATMENT OPTIONS AVAILABLE, AND SUGGEST A TREATMENT ALGORITHM FOR THIS SCENARIO BASED ON THE EVIDENCE. METHODS AND RESULTS: WE REPORT FOUR PATIENTS WHO WERE FOUND TO HAVE RENAL ARTERY OCCLUSION AFTER EVAR DETECTED UP TO 5 WEEKS POSTOPERATIVELY. RENAL REVASCULARIZATION WAS ACHIEVED USING ENDOVASCULAR RENAL ARTERY STENTING IN TWO PATIENTS, AND OPEN HEPATO-SPLENO-RENAL BYPASS IN THE REMAINING TWO CASES. TREATMENT STRATEGIES USED LED TO SYMPTOM RESOLUTION AND RECOVERY OF RENAL FUNCTION IN ALL CASES. CONCLUSIONS: BOTH OPEN AND ENDOVASCULAR TECHNIQUES MAY BE USED AS PROCEDURES TO TREAT THIS CONDITION. THE CHOICE OF PROCEDURE IS PRIMARILY DETERMINED BY ACCESSIBILITY OF THE RENAL ORIFICE. AN (B)(6) MAN UNDERWENT AN ELECTIVE EVAR FOR AN INFRARENAL AAA USING A MEDTRONIC ENDURANT STENT ((B)(4)). PREOPERATIVELY, HE WAS FOUND TO HAVE MILD CHRONIC RENAL IMPAIRMENT, WITH A CREATININE LEVEL OF 170 MMOL/L, AND HE WAS THEREFORE ADMITTED FOR INTRAVENOUS FLUID REHYDRATION AND ADMINISTRATION OF N-ACETYLCYSTEINE BEFORE THE SURGERY. THE PROCEDURE ITSELF WAS COMPLICATED BY A TYPE 1A ENDOLEAK NECESSITATING PROXIMAL EXTENSION. COMPLETION ANGIOGRAPHY DEMONSTRATED SOME CONTRAST FILLING OF THE RENAL ARTERIES BILATERALLY, AND HE WAS DISCHARGED 2 DAYS POSTOPERATIVELY. THREE WEEKS POSTOPERATIVELY, HE WAS READMITTED WITH ACUTE RENAL FAILURE AND A CREATININE LEVEL OF 300 MMOL/L; ULTRASONOGRAPHIC SCANNING SHOWED THINNING OF THE LEFT RENAL CORTEX AND HETEROGENOUS APPEARANCE OF THE RIGHT KIDNEY. SUBSEQUENT CT SCANNING DEMONSTRATED COMPLETE COVERAGE OF THE LEFT RENAL ARTERY BY THE FABRIC OF THE MAIN AORTIC STENT GRAFT, AND THE ORIGIN OF THE RIGHT RENAL ARTERY PARTIALLY COVERED BY THE STENT-GRAFT FABRIC, WITH A SIGNIFICANT UNDERLYING RENAL ARTERY STENOSIS. THE PATIENT WAS TRANSFERRED TO OUR INSTITUTION AND UNDERWENT HEMOFILTRATION. USING LOCAL ANESTHESIA AND LEFT BRACHIAL ARTERY ACCESS VIA A 6-F SHEATH, ANGIOGRAPHY WAS PERFORMED, WHICH CONFIRMED THE SIGNIFICANT COMPROMISE OF THE RIGHT RENAL ARTERY ORIGIN BY THE STENT GRAFT AND OCCLUSION OF THE LEFT RENAL ARTERY AT THE ORIGIN. SELECTIVE CATHETERIZATION OF THE RIGHT RENAL ARTERY THROUGH A LONG 7-F CATHETER AS IN CASE 1 WAS FOLLOWED BY SUCCESSFUL DEPLOYMENT OF A BALLOON-EXPANDABLE STENT. EXCELLENT ANGIOGRAPHIC RESULTS WERE OBTAINED, AND NO IMMEDIATE COMPLICATIONS WERE REPORTED. AT A 3-MONTH FOLLOW-UP, THE PATIENT'S RENAL FUNCTION SIGNIFICANTLY IMPROVED, WITH A CREATININE LEVEL OF 190 MMOL/L, AND FOLLOW-UP IMAGING REVEALED NO ENDOLEAK OR INCREASE IN SAC SIZE. ANN VASC SURG 2012; 26: 1127.E1E1127.E7.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Required Intervention