BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3962154 · Received July 28, 2014

    Report

    Report Number
    2031527-2014-00230
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 19, 2014
    Report Date
    July 19, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 REMAINS IMPLANTED IN PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. MEDICAL RECORDS AND COMPUTER TOMOGRAPHY IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: APPROXIMATELY 44 MONTHS POST INDEX, THE AORTO-UNI-ILIAC, FEM-FEM BYPASS AND IMA PLUG PROCEDURE WAS CONFIRMED FOR A REPORTED LEAK AND SAC INCREASE. THERE WAS RADIOLOGICAL EVIDENCE THAT SUPPORTED AN ENDOLEAK TYPE IA POST THIS PROCEDURE; THE PRE-SURGICAL CT SCAN WAS NOT AVAILABLE FOR REVIEW. THIS CASE MIGHT BE BEST DESCRIBED AS AN UNKNOWN ENDOLEAK DUE TO THE NORMAL ANGIOGRAM REPORT IN THE FACE OF PRIOR REPORTED ENDOLEAKS OF: ENDOLEAK TYPE IA, IB AT INDEX; AND, ENDOLEAK TYPE IIIB RIGHT ILIAC/AORTIC JUNCTION. THERE MIGHT HAVE BEEN LATER EVIDENCE OF AN ENDOLEAK TYPE IIIA, STENT IN-FOLDING AND PROGRESSIVE MIGRATION PRIOR TO THE AUI GRAFT PLACEMENT. THERE WERE TWO SECONDARY PROCEDURES; A DIAGNOSTIC ANGIOGRAM AND THE SURGICAL TREATMENT FOR THE UNKNOWN AND THE ENDOLEAK TYPE II FROM THE IMA. 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, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED ENDOLEAKS AND OTHER COMPLICATIONS COULD NOT BE DEFINITELY DETERMINED. HOWEVER, PATIENT ANATOMY AND MEDICAL CONDITIONS PLAYED A ROLE IN THE OUTCOME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 44 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, THE PATIENT WAS ADMITTED WITH BACK PAIN AND THE ABDOMINAL AORTIC INFRARENAL ANEURYSM SIZE WAS FOUND TO BE 9 CM. A SERIES OF CTS PERFORMED REVEALED A LESION WITH HETEROGENEOUS DENSITY AT THE RIGHT ANTERIOR ASPECT OF THE LARGE ABDOMINAL AORTIC ANEURYSM SUGGESTING AN ACUTE HEMATOMA FROM AN ANEURYSM LEAK. THE PHYSICIAN WAS UNABLE TO DETERMINE THE LOCATION OF THE LEAK, THE STUDY WAS PERFORMED WITHOUT IV CONTRAST. BILATERAL RENAL VASCULAR CALCIFICATIONS WERE ALSO OBSERVED. THE PHYSICIAN ELECTED TO BRING THE PATIENT BACK AND PERFORMED A COIL EMBOLIZATION OF THE PREVIOUSLY IMPLANTED SNORKEL. ADDITIONALLY, THE PHYSICIAN TREATED THE PATIENT WITH AN AUI (AORTO-UNI-ILIAC) APPROACH. THE PATIENT WAS REPORTED TO BE DOING WELL POST-PROCEDURE. ADDITIONAL NOTE: DURING THE INITIAL PROCEDURE, ADDITIONAL TO THE IMPLANTATION OF THE ENDOVASCULAR DEVICES, THE PHYSICIAN HAD PERFORMED A SNORKEL PROCEDURE OF THE RIGHT HYPOGASTRIC ARTERY. THE PATIENT HAD ALSO PRESENTED WITH BILATERAL COMMON ILIAC ARTERY DISEASE. REPORTEDLY, FROM INITIAL PRESENTATION 43 MONTHS AGO TO DATE, THE ABDOMINAL ANEURYSM HAS CONTINUED TO GROW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 43.4 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, THE PATIENT WAS ADMITTED WITH BACK PAIN AND THE ABDOMINAL AORTIC ANEURYSM SIZE WAS FOUND TO BE 9 CM. THE PHYSICIAN WAS UNCERTAIN IF THE ENDOLEAK WAS POSSIBLY A TYPE II OR A TYPE III, ON THE RIGHT DISTAL END AT THE RIGHT ILIAC ARTERY. THE PHYSICIAN HAS PLANS TO PERFORM A SECONDARY INTERVENTION VERY SOON, IF THE PATIENT IS STABLE.ADDITIONAL NOTE: DURING THE INITIAL PROCEDURE, ADDITIONAL TO THE IMPLANTATION OF THE ENDOVASCULAR DEVICES, THE PHYSICIAN HAD PERFORMED A SNORKEL PROCEDURE OF THE RIGHT HYPOGASTRIC ARTERY. THE PATIENT HAD ALSO PRESENTED WITH BILATERAL COMMON ILIAC ARTERY DISEASE. REPORTEDLY, FROM INITIAL PRESENTATION 43 MONTHS AGO TO DATE, THE ABDOMINAL ANEURYSM HAS CONTINUED TO GROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437958 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 34-34-120RLE W10-3561-002

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention