BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 3881680 · Received June 18, 2014

    Report

    Report Number
    2031527-2014-00205
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIFURCATED DEVICE AND THE ALSO EXPLANTED SUPRARENAL AORTIC EXTENSION WERE RETURNED FOR EVALUATION. THE BIFURCATED DEVICE WAS ADDITIONALLY SENT OUT TO AN INDEPENDENT LAB FOR PATHOLOGY EXAMINATION WITH THIS CONCLUSION: RADIOGRAPHIC IMAGING SHOWED THERE WERE NO STENT CRACKS OR FRACTURES. THE EXPLANT WAS FURTHER EVALUATED IN-HOUSE AT THE MANUFACTURER FACILITY. THE EXPLANT WAS CLEANED OF THROMBUS AND COAGULATED BLOOD THAT ADHERED TO THE INSIDE OF THE STENT GRAFT LUMENS. MINIMAL COAGULATED BLOOD WAS REMOVED FROM A FEW SPOTS ON THE OD. UPON CLEANING, SIX HOLES OF VARYING SIZES FROM 2.5X2MM TO 0.3X0.3MM WERE FOUND ON THE BIFURCATED STENT GRAFT. OF WHICH, THREE HOLES, TWO 1X1MM AND ONE 0.5X0.5MM, WERE LATERAL. IT COULD NOT BE CONFIRMED IF ANY OF THESE LATERAL HOLES MATCH THE REPORTED PINHOLE NOTED AT THE BOTTOM, RIGHT ANTERIOR LATERAL WALL OF THE BIFURCATED DEVICE. THEY MIGHT HAVE RESULTED FROM THE EXPLANT PROCEDURE, OR DURING MANIPULATION OF THE DEVICE DURING IN-HOUSE CLEANING AND SEPARATION. DURING INSPECTION OF THE SUPRARENAL AORTIC EXTENSION, FOUR HOLES WERE OBSERVED, 2X1.5MM, 2X1MM, 1X0.5MM AND 0.5X0.5MM. ALL THE HOLES APPEARED TO BE COVERED BY THE OVERLAP BETWEEN THE BIFURCATED AND SUPRARENAL EXTENSION AND BY THROMBUS THAT LINED UP THE LUMEN. THE 2.5X2MM HOLE ON THE BIFURCATED AND THE 2X1.5MM HOLE IN THE SUPRARENAL CUFF ARE THE ONLY HOLES THAT POSSIBLY LINE UP; HOWEVER, THEY WERE COVERED BY THROMBUS.MEDICAL RECORDS AND COMPUTER TOMOGRAPHY IMAGING WERE RECEIVED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THERE WAS SUBOPTIMAL MEDICAL DOCUMENTATION AND IMAGING STUDIES AVAILABLE FOR REVIEW. PRODUCT USE MIGHT HAVE BEEN INCONGRUENT WITH THE IFU, AND MIGHT HAVE CONTRIBUTED TO THE EVENT DUE TO: MULTIPLE PATENT LUMBAR ARTERIES AND A LARGE PATENT IMA. THE PATIENT WAS PLACED ON ANTIPLATELET THERAPY DURING THE COURSE OF THE DEVICE, WHICH MIGHT HAVE BEEN A CONTRIBUTING FACTOR. UNRESOLVED ENDOTENSION MIGHT HAVE CONTRIBUTED TO THE OUTCOME; THERE WAS SUBSTANTIATING EVIDENCE TO SUPPORT ENDOLEAK TYPE II OF AN UNRESOLVED LUMBAR (SUPERIOR STENT MARGIN AND MID BODY) AND THE IMA (RESOLVED). THERE WAS RADIOGRAPHICAL EVIDENCE OF AN AORTIC CUFF DIAMETER 28% LESS THAN EXPECTED DIAMETER, ALONG WITH A THIN, MURAL THROMBUS WITHIN THE MAIN BODY STENT. THERE WAS MEDICAL DOCUMENTATION OF AN ENDOLEAK TYPE IA, ALTHOUGH THIS WAS NOT WELL DEMONSTRATED IN THE STUDIES, DUE TO THE NON-DYNAMIC NATURE OF SOME OF THE ANGIOGRAM SERIES. THERE WAS EVIDENCE OF SLIGHT INFERIOR AORTIC CUFF MIGRATION TWENTY-ONE MONTHS POST INDEX. THERE WAS MEDICAL DOCUMENTATION OF AN ENDOLEAK TYPE IIIB AT EXPLANT, AND COULD NOT BE EXCLUDED AS A POSSIBLE SOURCE OF THE ENDOLEAK SEEN IN THE MID-BODY AND RIGHT LATERAL AREAS. TWO SEPARATE ANGIOGRAM PROCEDURES (SECONDARY PROCEDURES) WERE SUBSTANTIATED: ONE DIAGNOSTIC, ONE INTERVENTIONAL - IMA COILING. THE CONVERSION, EXPLANT AND DEATH WERE SUBSTANTIATED. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED ALL UNITS HAVE BEEN CONSUMED AND NO OTHER UNITS WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT IS INCONCLUSIVE. THE CAUSE OF THE HOLES ON THE RETURNED STENT GRAFT COMPONENTS IS NOT DETERMINED. HOWEVER, FACTORS ASSOCIATED WITH TYPE III-B ENDOLEAK INCLUDE DAMAGE DUE TO CONTACT WITH CALCIFICATION, INADVERTENT PHYSICIAN ERROR DURING INITIAL IMPLANT OR SECONDARY PROCEDURE (E.G., GUIDEWIRE MANIPULATION, BALLOONING, INSERTION OF OTHER DEVICES OR CATHETERS, ETC.), PROCEDURAL OR LATE COMPLICATIONS AND/OR EROSIONS INDUCED BY ANATOMICAL CONDITIONS, OFF-LABEL USE OF COMPETITOR DEVICES THAT MAY CONTAIN ANCHORING HOOKS/BARBS, AND POTENTIAL MANUFACTURING DEFECTS. THESE ENDOLEAKS CAN OCCUR INTRAOPERATIVELY OR OVER TIME.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 24 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, THE DEVICES WERE EXPLANTED. REPORTEDLY, A LARGE INFERIOR MESENTERIC ARTERY WAS COILED 15 MONTHS POST IMPLANT OF THE REFERENCED DEVICES, DUE TO A TYPE II ENDOLEAK. THE REPORT INDICATES THE ANEURYSM SAC HAD CONTINUED TO GROW AND ON THE LATEST COMPUTED TOMOGRAPHY SCAN PERFORMED ON (B)(6) 2014, AN ENDOLEAK AT THE BOTTOM ASPECT OF THE BIFURCATION WAS OBSERVED AND AN ENDOLEAK TYPE II AS WELL. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND TREAT THE PATIENT WITH A SURGICAL GRAFT. INTRA-OPERATIVELY, THE PATIENT LOST 1800 ML OF BLOOD, BUT THE POST-OPERATIVE HEMOGLOBIN WAS DENOTED TO BE 10.9 MG/DL (SIMILAR TO PRE OP LEVELS). THE PATIENT WAS SENT TO RECOVERY. IN RECOVERY, THE PATIENT BECAME HYPOTENSIVE, AND EXPERIENCED CARDIAC ARREST TWICE. THE PATIENT WAS INTUBATED AND PLACED ON VENTILATOR; FLUID RESUSCITATION AND VASOPRESSORS WERE NEEDED TO STABILIZE THE PATIENT. THE PATIENT WAS TAKEN BACK TO SURGERY FOR AN EXPLORATION. THERE WAS SUSPICION OF ISCHEMIC BOWEL AND COMPARTMENT SYNDROME. APPROXIMATELY 500 CC OF OLD WOUND HEMATOMA WAS EVACUATED. SOMETIME POST THE SECOND SURGERY, THE PATIENT WAS SHOWING SIGNS OF ANOXIC ENCEPHALOPATHY. THE PATIENT WAS PLACED ON COMFORT CARE, EXTUBATED, AND EXPIRED SHORTLY AFTERWARDS. THE CAUSE OF DEATH WAS DETERMINED AS: ANOXIC ENCEPHALOPATHY; MULTI-ORGAN FAILURE; ISCHEMIC BOWEL; LACTIC ACIDOSIS. ONCE THE BIFURCATED DEVICE WAS EXPLANTED, A PINHOLE WAS NOTED AT THE BOTTOM RIGHT INTERIOR LATERAL WALL OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 24 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, THE DEVICES WERE EXPLANTED. REPORTEDLY, A LARGE INFERIOR MESENTERIC ARTERY WAS COILED 15 MONTHS POST IMPLANT OF THE REFERENCED DEVICES, DUE TO A TYPE II ENDOLEAK. THE REPORT INDICATES THE ANEURYSM SAC HAD CONTINUED TO GROW AND ON THE LATEST COMPUTED TOMOGRAPHY SCAN PERFORMED ON (B)(6) 2014, AN ENDOLEAK AT THE BOTTOM ASPECT OF THE BIFURCATION WAS OBSERVED AND AN ENDOLEAK TYPE II AS WELL. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND TREAT THE PATIENT WITH A SURGICAL GRAFT. ONCE THE BIFURCATED DEVICE WAS EXPLANTED, A PINHOLE WAS NOTED AT THE BOTTOM RIGHT INTERIOR LATERAL WALL OF THE DEVICE. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358876 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-100/I16-40 1029092-004

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| R