BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2852952 · Received November 30, 2012

    Report

    Report Number
    2953200-2012-02291
    Event Type
    Injury
    Date Received
    November 30, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MEDTONIC IRELAND
    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

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (RENAL FAILURE, OCCLUSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (PRE-OPERATIVE RUPTURED ANEURYSM); INCORRECT TECHNIQUE/PROCEDURE (TREATMENT OF A PRE-OPERATIVE RUPTURED ANEURYSM). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (PRE-OPERATIVE RUPTURED ANEURYSM); OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF A PRE-OPERATIVE RUPTURED ANEURYSM).

    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 CONDITIONED THE CHOICE OF PROCEDURE IS PRIMARILY DETERMINED BY ACCESSIBILITY OF THE RENAL ORIFICE. A (B)(6) MAN PRESENTED TO HIS LOCAL HOSPITAL WITH SUDDEN-ONSET LOIN PAIN. URGENT COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY DEMONSTRATED A RUPTURED INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) WITH A SIGNIFICANTLY ANGULATED PROXIMAL NECK. HE UNDERWENT EMERGENCY ENDOVASCULAR ANEURYSM REPAIR RECEIVING LOCAL ANESTHESIA. AN AORTOUNIILIAC MEDTRONIC ENDURANT STENT ((B)(4)) WAS DEPLOYED VIA THE RIGHT GROIN, FOLLOWED BY LIMB EXTENSION TO THE RIGHT COMMON ILIAC ARTERY (CIA) AND AMPLATZER 22-MM DEVICE PLACEMENT TO OCCLUDE THE PROXIMAL LEFT CIA. THE POSTDEPLOYMENT ANGIOGRAM DEMONSTRATED A TYPE 1A ENDOLEAK, WHICH WAS MANAGED WITH A PROXIMAL AORTIC EXTENSION CUFF. COMPLETION ANGIOGRAM CONFIRMED EXCLUSION OF THE ANEURYSM, NO ENDOLEAK, AND PERFUSION OF BOTH RENAL ARTERIES. A RIGHT-TO-LEFT FEMORALE FEMORAL CROSSOVER GRAFT WAS THEN CONSTRUCTED USING AN 8-MM DACRON GRAFT. HE WAS SUBSEQUENTLY TRANSFERRED TO OUR INSTITUTION, NECESSITATED BY INTENSIVE CARE UNIT (ICU) BED UNAVAILABILITY AT HIS LOCAL HOSPITAL. ALTHOUGH HE APPEARED WELL INITIALLY POSTOPERATIVELY, WORSENING OLIGURIA, SIGNIFICANT RESPIRATORY COMPROMISE, AND RISING INTRA-ABDOMINAL COMPARTMENT PRESSURES MANDATED URGENT LAPAROSTOMY FORMATION WITH BOGOTA BAG CLOSURE AT 18 HOURS AFTER EVAR. AFTER THIS, HE BECAME ANURIC. SUBSEQUENT CT SCANNING DEMONSTRATED COVERAGE OF BOTH RENAL ARTERIES, WITH SOME LEFT RENAL VESSEL FILLING VIA A SMALL CHANNEL BETWEEN THE MAIN BODY OF THE STENT GRAFT AND THE AORTA. HE UNDERWENT URGENT ANGIOGRAPHY AND CHIMNEY STENT PLACEMENT. ACCESS WAS OBTAINED FROM THE LEFT BRACHIAL ARTERY VIA A 6-F SHEATH. A 0.035-INCH TERUMO WIRE (TERUMO EUROPE, LEUVEN, BELGIUM) WAS PASSED BETWEEN THE MAIN BODY OF THE STENT GRAFT AND THE AORTIC WALL INTO THE LEFT RENAL ARTERY AND EXCHANGED FOR A 0.035-INCH AMPLATZ WIRE (COOK MEDICAL, (B)(4)). A 7-MM BALLOON WAS INFLATED BETWEEN THE AORTA AND THE MAIN OF THE BODY DEVICE TO LIFT THE FABRIC OF THE STENT AWAY FROM THE AORTIC WALL. THREE 6 22-MM ADVANTA COVERED STENTS (ATRIUM, (B)(4)) WERE SUBSEQUENTLY DEPLOYED TO BRIDGE THE GAP BETWEEN THE AORTA AND THE LEFT RENAL ARTERY. POSTOPERATIVE ANGIOGRAMS DEMONSTRATED GOOD STENT POSITION, PERFUSION OF THE LEFT RENAL ARTERY, AND NO EVIDENCE OF AN ENDOLEAK. THERE WAS NO ATTEMPT MADE TO SALVAGE THE RIGHT RENAL ARTERY BECAUSE THIS KIDNEY WAS MOST LIKELY ISCHEMIC, AND THE PATIENT WAS TOO UNSTABLE FOR BILATERAL PROLONGED ATTEMPTS AT RENAL SALVAGE. DURING HIS 62-DAY ITU STAY, HE UNDERWENT CLOSURE OF LAPAROSTOMY DEFECT USING A PERMACOL PORCINE COLLAGEN MESH (COVIDIEN (B)(4)), AND REQUIRED A PROLONGED RESPIRATORY WEAN AND 28 DAYS OF HEMOFILTRATION. ON DISCHARGE, HIS RENAL FUNCTION RETURNED TO BASELINE, WITH A CREATININE LEVEL OF 90 MMOL/L. FOLLOW-UP SCANNING AT 6 MONTHS REVEALED NO ENDOLEAK OR INCREASE IN SAC SIZE. THE PATIENT'S SYMPTOMS POST-IMPLANT WERE WORSENING OLIGURIA, SIGNIFICANT RESPIRATORY COMPROMISE, RISING INTRA-ABDOMINAL COMPARTMENT PRESSURES, BECAME ANURIC. THIS DEVICE IS NOT MARKETED IN THE UNITED STATES HOWEVER IT IS SIMILAR TO A DEVICE THAT IS MARKETED IN THE UNITED STATES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention