BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX2

    MDR report key: 10528550 · Received September 14, 2020

    Report

    Report Number
    2031527-2020-00256
    Event Type
    Death
    Date Received
    September 14, 2020
    Date of Event
    August 18, 2020
    Report Date
    August 18, 2020
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    008009014399
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    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. THE REVIEW CONFIRMS THERE WERE NO MANUFACTURING OR PROCESSING NON-CONFORMITIES IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ADVERSE EVENT/INCIDENT. THERE ARE NO OTHER EQUIVALENT ADVERSE EVENTS/INCIDENTS FOR THIS LOT NUMBER EXISTING WITHIN THE ENDOLOGIX COMPLAINT HANDLING SYSTEM. ENDOLOGIX RECEIVED A ONE (1) AFX2 BIFURCATED STENT GRAFT, TWO (2) VELA SUPRARENAL STENT GRAFT AND ONE (1) OVATION IX STENT GRAFT EXTENDER FOR EVALUATION. THE DEVICES WERE SHIPPED IN A BIOHAZARD EXPLANT RETURNED CONTAINER. BLOOD AND TISSUE RESIDUE WERE PRESENT UPON RECEIPT. THE DEVICES WERE DECONTAMINATED. A VISUAL ANALYSIS WAS PERFORMED. ALL FOUR (4) STENT GRAFTS WERE CONNECTED TO EACH OTHER. THE INTEGRITY OF THE GRAFT APPEARS TO BE INTACT WITH NO VISIBLE DEFECTS FOR THE AFX2 BIFURCATED STENT GRAFT AND THE OVATION IX STENT GRAFT EXTENDER. BOTH VELA SUPRARENAL STENT GRAFTS WERE IMPLANTED WITHIN EACH OTHER AND WERE ATTACHED TO THE PROXIMAL END OF THE BIFURCATED STENT GRAFT. ONE VELA SUPRARENAL STENT GRAFT WAS IMPLANTED WITHIN THE OTHER VELA SUPRARENAL STENT GRAFT. THERE IS A LARGE HOLE IDENTIFIED IN THE GRAFT OF THE OUTER VELA SUPRARENAL STENT GRAFT. THE CROWN OF THE INNER VELA SUPRARENAL STENT GRAFT CAN BE SEEN COMING THRU THE GRAFT. AS THE DEVICE WAS ONLY IMPLANTED FOR A FEW HOURS, THIS LARGE HOLE MAY HAVE BEEN CAUSED DURING THE EXPLANTING OF THE DEVICE. THE CAUSE OF THE DAMAGE IS INCONCLUSIVE. A CLINICAL EVALUATION OF THE ADVERSE EVENT / INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX WERE UNABLE TO CONFIRM THE REPORT EVENTS OF A TYPE 3B ENDOLEAK, TYPE 2 ENDOLEAK AND EXPLANT DURING OPEN REPAIR PROCEDURE. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT / INCIDENT. THE CLINICAL EVALUATION ALSO SHOWS REASONABLE EVIDENCE TO SUGGEST AN URGENT PRESENTATION WITH AORTIC RUPTURE PRIOR TO THE STENT GRAFTS BEING IMPLANTED AND PATIENT DEATH OCCURRED ONE (1) DAY POST EMERGENT ENDOVASCULAR PROCEDURE ON (B)(6) 2020 AT 1546. THE CONTRIBUTING FACTORS FOR THE TYPE 3B ENDOLEAK, OPEN REPAIR AND EXPLANT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. HOWEVER THIS CASE WAS OFF LABEL DUE TO THE CONCOMITANT USE WITH PRODUCTS OUTSIDE THE IFU AND CAUTIONARY USE TYPE OF LEAKING, PENDING RUPTURE OR RUPTURED ANEURYSMS. THE CONTRIBUTING FACTORS FOR THE DEATH IS MOST LIKELY PROCEDURE RELATED (ENDOVASCULAR REPAIR AND/OR OPEN REPAIR) AND PRE-EXISTING CONDITIONS OF RUPTURED AORTA. 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. CORRECTIONS: B5: DESCRIBE EVENT OR PROBLEM HAS BEEN UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER HAS BEEN UPDATED. H5: LABELED FOR SINGLE USE HAS BEEN UPDATED. H6: METHOD CODE: REMOVE CODE 4114. H6: RESULT CODE: REMOVE CODE 3233. H6: CONCLUSION CODE: REMOVE CODE 11.

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT SYSTEM, TWO (2) SUPRARENAL STENT GRAFT EXTENSION, AND AN OVATION EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. THE INITIAL PROCEDURE WAS SUCCESSFUL WITH NO ISSUES OR ENDOLEAK IDENTIFIED. WHILE IN THE ICU, THE PATIENT'S HEALTH STARTED TO DECLINE AND WAS BROUGHT BACK INTO SURGERY. THE PATIENT WAS NOTED TO HAVE COMPARTMENTAL SYNDROME. A TYPE 3B ENDOLEAK AND TYPE 2 ENDOLEAK (NON- DEVICE RELATED FAILURE) WAS IDENTIFIED. THE PHYSICIAN REMOVED THE DEVICE AND USED A SURGICAL GRAFT FOR IMPLANTATION. THE PATIENT STATUS WAS REPORTED AS DOING WELL. CORRECTIONS AND UPDATED INFORMATION: THE PATIENT WAS PRESENT TO THE HOSPITAL WITH DIZZINESS AND WEAKNESS HOWEVER WAS SENT HOME STABLE THE NEXT DAY. THE PATIENT WAS THEN PRESENT TO THE HOSPITAL FIVE (5) DAYS LATER WITH A RUPTURED AORTA. THE PATIENT WAS THEN IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT SYSTEM, TWO (2) SUPRARENAL STENT GRAFT EXTENSION, AND AN OVATION EXTENDER TO TREAT THE RUPTURED AORTA. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU AND CAUTIONARY USE DUE TO THE RUPTURED ANEURYSM. THE INITIAL PROCEDURE WAS SUCCESSFUL WITH NO ISSUES OR ENDOLEAK IDENTIFIED. WHILE IN THE ICU, THE PATIENT'S HEALTH STARTED TO DECLINE AND WAS BROUGHT BACK INTO SURGERY. THE PATIENT WAS NOTED TO HAVE COMPARTMENTAL SYNDROME. A POSSIBLE TYPE 3B ENDOLEAK AND TYPE 2 ENDOLEAK (NON- DEVICE RELATED FAILURE) WERE IDENTIFIED. THE PHYSICIAN PERFORMED AN OPEN REPAIR WITH A SURGICAL GRAFT AND EXPLANTED THE DEVICES. THE PATIENT BECAME HYPOTENSIVE DUE TO BLOOD LOSS AND WAS GIVEN MULTIPLE BLOOD PRODUCTS. IT WAS NOTED THAT THE PATIENT HAS A DNR (DO NOT RESUSCITATE) ORDER. THE PATIENT EXPIRED ONE (1) DAY POST EMERGENT ENDOVASCULAR PROCEDURE ON (B)(6) 2020 AT 1546. THE CAUSE OF DEATH WAS NOT DETERMINED AS MULTIPLY CONTRIBUTING FACTORS WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN REPORTED FOR AN 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. THE DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT SYSTEM, TWO (2) SUPRARENAL STENT GRAFT EXTENSION, AND AN OVATION EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. THE INITIAL PROCEDURE WAS SUCCESSFUL WITH NO ISSUES OR ENDOLEAK IDENTIFIED. WHILE IN THE ICU, THE PATIENT'S HEALTH STARTED TO DECLINE, AND WAS BROUGHT BACK INTO SURGERY. THE PATIENT WAS NOTED TO HAVE COMPARTMENTAL SYNDROME. A TYPE 3B ENDOLEAK AND TYPE 2 ENDOLEAK (NON- DEVICE-RELATED FAILURE) WAS IDENTIFIED. THE PHYSICIAN REMOVED THE DEVICE AND USED A SURGICAL GRAFT FOR IMPLANTATION. THE PATIENT STATUS WAS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993572 AFX2 AFX2 BIFURCATED STENT GRAFT MIH ENDOLOGIX BEA28-120/I20-40 2317457008 008009014399

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R OVATION IX EXTENDER FS040120-02| VELA SUPRARENAL 2335826001| VELA SUPRARENAL 2344505006| OVATION IX EXTENDER (B)(4) | VELA SUPRARENAL (B)(4) | VELA SUPRARENAL (B)(4)