BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 6370382 · Received March 1, 2017

    Report

    Report Number
    2031527-2017-00086
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    January 30, 2017
    Report Date
    January 30, 2017
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. DEVICES REMAIN IMPLANTED IN THE PATIENT AND WERE NOT RETURNED, NO EVALUATION COMPLETED. AT THE COMPLETION OF THE CLINICAL ASSESSMENT, CLINICAL WAS ABLE TO FIND SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING REPORTED EVENTS OF RELINE WITH OVATION, CONTAINED AORTIC RUPTURE, PERSISTENT ENDOLEAK TYPE II AT THE L4 LUMBAR, SURGICAL INTERVENTION FOR AN AORTIC SAC DECOMPRESSION, TYPE 1B ENDOLEAK, LEFT INTERNAL ILIAC/ THE HYPOGASTRIC ARTERY FOR AFX, OVATION EXTENSION AND NON-ENDOLOGIX STENT, SECONDARY SURGICAL PROCEDURE (OPEN LIGATION OF 2 LUMBAR ARTERIES) AND FINAL PATIENT STATUS AS STABLE. CUMULATIVE KNOWLEDGE INFORMED BY PAST ASSESSMENTS OF SIMILAR COMPLAINTS WAS APPLIED TO A REVIEW OF THE AVAILABLE MEDICAL INFORMATION. THE MOST LIKELY CAUSE OF THE LOSS OF SEAL WAS RELATED TO THE LARGE DIAMETER OF THE COMMON ILIAC ARTERY NOW MEASURING OUTSIDE THE INDICATIONS FOR THE PREVIOUSLY IMPLANTED GRAFT. NO PROCEDURE-RELATED ISSUES OR USER RELATED ISSUES. OFF-LABEL OR CAUTIONARY PRODUCT USE CONDITIONS WERE DETERMINED. ASSOCIATED CLINICAL HARMS FOR THIS DEVICE FAILURE INCLUDED: PAIN, ANEURYSM ENLARGEMENT, TYPE 1B ENDOLEAK, RUPTURE, SECONDARY ENDOVASCULAR PROCEDURE, AND A SECONDARY SURGICAL PROCEDURE. THE FINAL PATIENT DISPOSITION WAS DISCHARGED POST OPERATIVE DAY SIX IN STABLE CONDITION. THERE WAS NO DEVICE RELATED ISSUE INVOLVING THE PERSISTENT TYPE II ENDOLEAK, THE CAUTIONARY PRODUCT USE CONDITION OF PATENT LUMBAR ARTERIES, LIKELY CONTRIBUTED TO THE CLINICAL HARM: TYPE II ENDOLEAK. ENDOLOGIX CONTINUES TO INVESTIGATE THIS EVENT AND SIMILAR EVENTS TO ENSURE THE HIGHEST QUALITY AND PATIENT SAFETY. THESE TYPES OF EVENTS WILL BE MONITORED AND TRENDED AS PART OF THE QUALITY SYSTEM. CORRECTION: INITIAL REPORTER, NAME AND ADDRESS, UPDATED INFORMATION TO CORRECT INFORMATION. CONTACT OFFICE- NAME, UPDATED INFORMATION TO CORRECT INFORMATION. PMA/501(K), CORRECTED TO P040002. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION, THEY REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2014 WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND 5 LIMB STENT GRAFTS. ON (B)(6) 2014 THE PATIENT HAD A POTENTIAL TYPE 2 OR TYPE 3 ENDOLEAK, THE PHYSICIAN ELECTED TO COMPLETE ANGIOPLASTY AND IMPLANT AN ADDITIONAL SUPRARENAL STENT. IT WAS REPORTED THERE WERE ALSO TWO NON-ENDOLOGIX STENTS IMPLANTED, UNKNOWN IF THE IMPLANT WAS AT THE INITIAL PROCEDURE OR THE SECONDARY ON (B)(6) 2014. ON (B)(6) 2015, THE PHYSICIAN DID A RE-LINE WITH OVATION DEVICES DUE TO ANEURYSM SAC GROWTH, NO VISIBLE LEAK WAS REPORTED. ON (B)(6) 2017 THE PATIENT CAME IN EMERGENTLY WITH A CONTAINED RUPTURED ANEURYSM. A COMPUTED TOMOGRAPHY (CT) SHOWED A POTENTIAL TYPE 1B ENDOLEAK OF THE LEFT LIMB OR A POTENTIAL TYPE 3A SINCE THE LEAK APPEARS TO BE BETWEEN THE TWO LIMBS. THE CT ALSO SHOWED A TYPE 2 ENDOLEAK WAS STILL PRESENT. ON (B)(6) 2017 THE PHYSICIAN IMPLANTED AN ADDITIONAL OVATION EXTENSION AND A NON-ENDOLOGIX STENT TO SEAL THE ENDOLEAK. ON (B)(6) 2017 THE PATIENT HAD AN ADDITIONAL PROCEDURE, THE PHYSICIAN DECOMPRESSED THE ANEURYSM BY REMOVING THROMBUS AND GRUMOUS. ADDITIONALLY THE PHYSICIAN LIGATED TWO LUMBAR ARTERIES AND SEWED THE ANEURYSM SAC BACK OVER THE GRAFT. THE PHYSICIAN OBSERVED A SMALL HOLE IN THE STRATA MATERIAL OF THE BIFURCATED GRAFT WHICH COULD HAVE BEEN CAUSED BY SUCTION OR FORCEPS USED IN THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151178 AFX BIFURCATED MIH ENDOLOGIX INC. BA28-80/I20-40 1101254-021

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention AORTO UNI-ILIAC [INFRARENAL]- (B)(4)| AORTO UNI-ILIAC [SUPRARENAL]- (B)(4)| LIMB- (B)(4)| LIMB- (B)(4)| LIMB- (B)(4)| LIMB- (B)(4)| LIMB- (B)(4)| OVATION IX- (B)(4)| OVATION IX- (B)(4)| OVATION PRIME- (B)(4)| PALMAZ STENT| PALMAZ STENT