BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 10320499 · Received July 24, 2020

    Report

    Report Number
    2031527-2020-00215
    Event Type
    Death
    Date Received
    July 24, 2020
    Date of Event
    June 27, 2020
    Report Date
    June 30, 2020
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009012418
    PMA / PMN Number
    P040002
    Removal / Correction Number
    Z-0006-2019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    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 EXPLANTED BUT WAS NOT RETURNED TO ENDOLOGIX FOR EVALUATION. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX CONFIRMS THE RUPTURE, OPEN REPAIR AND DEATH EVENTS. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE CLINICAL ASSESSMENT ALSO IDENTIFIED SAC GROWTH OF 13.5MM DURING REVIEW OF THE OPERATIVE REPORT DATED (B)(6) 2020, THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE PATIENT DEATH WAS DETERMINED TO BE DEVICE RELATED. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THE RUPTURE AND OPEN REPAIR COULD NOT BE DETERMINED. THE PROCEDURE RELATED HARMS IDENTIFIED WERE ABNORMAL BLOOD LOSS, HYPOTENSION AND AN ADDITIONAL SURGICAL PROCEDURE (SPLENECTOMY). THE MOST LIKELY CAUSATION FOR THE RUPTURE, OPEN REPAIR AND DEATH EVENTS IS INDETERMINATE. THE PREVIOUS SECONDARY PROCEDURE PERFORMED (B)(6) 2020, DEMONSTRATED TYPE 2 ENDOLEAKS OF THE LUMBAR AND LOSS OF OVERLAP OF THE AORTIC COMPONENTS, HOWEVER IT IS UNCLEAR IF THE TYPE 2 ENDOLEAKS CONTRIBUTED TO THE REPORTED EVENTS WITHOUT RELEVANT MEDICAL IMAGING. THE PATIENT WAS IN CRITICAL CONDITION WHEN TAKEN TO THE OR, AND A SPLENIC INJURY DUE TO SURGICAL DISSECTION NECESSITATING A SPLENECTOMY, LEFT ADRENAL BLEEDING AND POSSIBLE BLEEDING FROM THE PROXIMAL ANASTOMOSIS ALL CONTRIBUTED TO THE MASSIVE BLEEDING. THE CAUSATION OF THE POSSIBLE TYPE 3 ENDOLEAK DUE TO A PERFORATED ENDOGRAFT IS INDETERMINATE AS IT IS UNCLEAR IF THE DAMAGE OCCURRED DURING THE OPERATIVE PROCEDURE OR WAS THE CAUSE OF THE RUPTURE AND CANNOT BE INDEPENDENTLY CONFIRMED WITHOUT MEDICAL IMAGING. DURING THE INVESTIGATION AND WITH THE INFORMATION AVAILABLE, ENDOLOGIX FOUND NO EVIDENCE TO SUGGEST THE DEVICE WAS USED OFF-LABEL. THE FINAL PATIENT STATUS WAS REPORTED AS EXPIRED ON (B)(6) 2020, ONE (1) DAY POST SURGICAL OPEN REPAIR DUE TO HEMORRHAGIC SHOCK. 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 WITH DURAPLY. CORRECTIONS: B5: DESCRIBE EVENT OR PROBLEM HAS BEEN UPDATED; H6: RESULT CODE: REMOVE CODE 3233; H6: CONCLUSION CODE: REMOVE CODE 11.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION, TWO (2) LIMB STENT GRAFT EXTENSIONS, AND A VELA INFRARENAL GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE ER WITH A RUPTURED ANEURYSM IDENTIFIED WITH A CT (COMPUTED TOMOGRAPHY). THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND TWO (2) HOLES IN THE GRAFT (POSSIBLE 3B ENDOLEAK) AT THE BIFURCATION OF THE AFX BIFURCATED STENT GRAFT WERE IDENTIFIED. POST REPAIR THE PATIENTS AORTA RUPTURED AGAIN AND THE PATIENT EXPIRED. NOTE: THIS PATIENT HAD A PREVIOUS CASE MFR:2031527-2020-00068 DUE TO LACK OF OVERLAP BETWEEN MAIN BODY AND PROXIMAL EXTENSION, RE-INTERVENTION WAS COMPLETED. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED SAC GROWTH OF 13.5 MM HAD OCCURRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY THE CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX WITH DURAPLY.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION, TWO (2) LIMB STENT GRAFT EXTENSIONS, AND A VELA INFRARENAL GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE ER WITH A RUPTURED ANEURYSM IDENTIFIED WITH A CT (COMPUTED TOMOGRAPHY). THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES AND TWO (2 )HOLES IN THE GRAFT (POSSIBLE 3B ENDOLEAK) AT THE BIFURCATION OF THE AFX BIFURCATED STENT GRAFT WERE IDENTIFIED. POST REPAIR THE PATIENTS AORTA RUPTURED AGAIN AND THE PATIENT EXPIRED. THIS PATIENT HAD A PREVIOUS CASE MFR: 2031527-2020-00068 DUE TO LACK OF OVERLAP BETWEEN MAIN BODY AND PROXIMAL EXTENSION, RE-INTERVENTION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785752 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX BA25-120/I16-40 1339732001 00818009012418

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death AFX,LIMB STENT GRAF:LOT1252577006.| AFX,LIMB STENT GRAF:LOT1252611020.| AFX,VELA INFRARENAL,LOT1679306002.| AFX,VELA SUPRARENAL,LOT1296431018.| AFX,LIMB STENT GRAF:LOT1252577006| AFX,LIMB STENT GRAF:LOT1252611020| AFX,VELA INFRARENAL,LOT1679306002| AFX,VELA SUPRARENAL,LOT1296431018