BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 14431471 · Received May 18, 2022

    Report

    Report Number
    2031527-2022-00102
    Event Type
    Death
    Date Received
    May 18, 2022
    Date of Event
    May 1, 2022
    Report Date
    May 1, 2022
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND REMAIN IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY A CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX WITH STRATA. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THE REPORTED ADVERSE EVENT/INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH ENDOLOGIX OPERATING PROCEDURES AND WORK INSTRUCTIONS. WHERE POSSIBLE, IT IS ENDOLOGIX PRACTICE TO MAKE AT LEAST THREE GOOD FAITH EFFORTS TO RETRIEVE A REPORTED ADVERSE EVENT/INCIDENT RELATED DEVICE AS WELL AS MEDICAL RECORDS AND MEDICAL IMAGING. AN EVALUATION OF THE MANUFACTURING RECORD WAS COMPLETED. A REVIEW OF THE PART NUMBER/LOT NUMBER COMBINATION NEEDED FOR DEVICE IDENTIFICATION SHOWS THE DEVICE TO HAVE BEEN PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. AN EVALUATION OF THE DEVICE COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED TO ENDOLOGIX FOR EVALUATION BECAUSE IT REMAINS IMPLANTED. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THE RUPTURE, UNSUCCESSFUL ATTEMPTED ENDOVASCULAR PROCEDURE, AND DEATH ARE CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE CLINICAL EVALUATION ALSO SHOWS REASONABLE EVIDENCE TO SUGGEST A TYPE IA ENDOLEAK AND SAC GROWTH OF 8MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THESE FINDINGS WERE DISCOVERED DURING AN EXAMINATION OF THE COMPUTERIZED TOMOGRAPHY SCAN DATED (B)(6) 2022. THE MOST LIKELY CAUSATION FOR RUPTURE WAS THE TYPE IA ENDOLEAK. THE OPERATIVE NOTE DATED (B)(6) 2022 STATED THAT THE PATIENT WAS LOST TO FOLLOW UP, THIS ALSO LIKELY CONTRIBUTED TO THE AORTIC RUPTURE. THE UNSUCCESSFUL ATTEMPTED ENDOVASCULAR PROCEDURE WAS MOST LIKELY ANATOMY RELATED. THE PROCEDURE AND RUPTURE RELATED HARMS HEMODYNAMIC INSTABILITY, ABNORMAL BLOOD LOSS AND CPR. THERE WERE FOUR PROXIMAL EXTENSIONS IN THE AORTIC NECK, THIS COULD HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE WAS A PREVIOUS EVENT (REPORTED UNDER MFR# 2031527-2017-00500), THAT INDICATED A TYPE IA ENDOLEAK. ON THE POST-SECONDARY IMAGING, IT APPEARED TO BE RESOLVED. THERE WAS SHARP ANGULATION OF THE SUPRARENAL NECK (88 DEGREES), IT IS UNCLEAR IF THIS CONTRIBUTED TO THE REPORTED EVENT. THE UNSUCCESSFUL ENDOVASCULAR PROCEDURE WAS LIKELY DUE TO THE SEVERE BILATERAL ILIAC TORTUOSITY. THE PATIENT DEATH WAS DETERMINED TO BE DEVICE RELATED. NO ADDITIONAL INVESTIGATION OF THIS REPORTED ADVERSE EVENT/INCIDENT IS PLANNED. HOWEVER, SHOULD ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION OUTCOME BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS AND SIMILAR ADVERSE EVENTS/INCIDENTS. DEVICE ITERATION IS AFX.. B5: DESCRIBE EVENT OR PROBLEM - UPDATED. G3: AWARENESS DATE ¿ UPDATED. H6: INVESTIGATION FINDING CODES - REMOVE CODE 3233. H6: INVESTIGATION CONCLUSION CODES - REMOVE CODE 11.

    Description of Event or Problem · 0

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AN AFX INFRARENAL AORTIC EXTENSION, AND AN AFX SUPRARENAL AORTIC EXTENSION. APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE THE FOLLOW-UP COMPUTED TOMOGRAPHY REVEALED A TYPE IIIA ENDOLEAK. TREATMENT OF THE TYPE IIIA ENDOLEAK WAS COMPLETED WITH THE IMPLANT OF AN AFX VELA SUPRARENAL AND AN AFX VELA INFRARENAL. ADDITIONALLY, AN OVATION IX EXTENDER WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE DUE TO A LARGE AND TORTUOUS RIGHT COMMON ILIAC ARTERY. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. INDEPENDENT CLINICAL REVIEW, HOWEVER, REFUTED THE REPORTED TYPE IIIA ENDOLEAK AND RATHER, CONFIRMED THE PRESENCE OF A TYPE IA ENDOLEAK. (REPORTED UNDER MFR# 2031527-2017-00500). APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST-REINTERVENTION, THE PATIENT¿S AORTA RUPTURED. AN ATTEMPT WAS MADE TO TREAT THE PATIENT WITH THE IMPLANT AN ALTO STENT GRAFT SYSTEM; HOWEVER, NO SHEATHS WERE ABLE TO PASS THE INITIALLY IMPLANTED AFX BIFURCATED STENT GRAFT DUE TO THE PATIENT ANATOMY. ALL DEVICES WERE REMOVED FROM THE PATIENT WITHOUT HARM. THE PATIENT WAS TRANSFERRED TO THE ICU WHERE THEY EXPIRED SHORTLY AFTER. REPORTEDLY, THE PATIENT WAS NOT ATTENDING REGULAR FOLLOW-UP.

    Description of Event or Problem · 0

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, AN AFX INFRARENAL AORTIC EXTENSION, AND AN AFX SUPRARENAL AORTIC EXTENSION. APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE THE FOLLOW-UP COMPUTED TOMOGRAPHY REVEALED A TYPE IIIA ENDOLEAK. TREATMENT OF THE TYPE IIIA ENDOLEAK WAS COMPLETED WITH THE IMPLANT OF AN AFX VELA SUPRARENAL AND AN AFX VELA INFRARENAL. ADDITIONALLY, AN OVATION IX EXTENDER WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE DUE TO A LARGE AND TORTUOUS RIGHT COMMON ILIAC ARTERY. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. INDEPENDENT CLINICAL REVIEW, HOWEVER, REFUTED THE REPORTED TYPE IIIA ENDOLEAK AND RATHER, CONFIRMED THE PRESENCE OF A TYPE IA ENDOLEAK. (REPORTED UNDER MFR# 2031527-2017-00500). APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST-REINTERVENTION, THE PATIENT¿S AORTA RUPTURED. AN ATTEMPT WAS MADE TO TREAT THE PATIENT WITH THE IMPLANT AN ALTO STENT GRAFT SYSTEM; HOWEVER, NO SHEATHS WERE ABLE TO PASS THE INITIALLY IMPLANTED AFX BIFURCATED STENT GRAFT DUE TO THE PATIENT ANATOMY. ALL DEVICES WERE REMOVED FROM THE PATIENT WITHOUT HARM. THE PATIENT WAS TRANSFERRED TO THE ICU WHERE THEY EXPIRED SHORTLY AFTER. REPORTEDLY, THE PATIENT WAS NOT ATTENDING REGULAR FOLLOW-UP. AFTER THE INITIAL REPORT, THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST A TYPE IA ENDOLEAK AND SAC GROWTH OF 8MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE TYPE IA ENDOLEAK AND SAC GROWTH WERE DISCOVERED DURING A REVIEW OF THE COMPUTERIZED TOMOGRAPHY SCAN DATED (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762972 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX BA25-100/I16-40 1047101-016

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death AFX INFRARENAL AORTIC EXTENSION (LN 1026588-017)| AFX SUPRARENAL AORTIC EXTENSION (LN 1026374-028)| AFX VELA INFRARENAL (LN 1594661-003)| AFX VELA SUPRARENAL (LN 1595136-035)| OVATION IX EXTENDER (LN FS040717-25)