BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTO

    MDR report key: 11935615 · Received June 3, 2021

    Report

    Report Number
    3008011247-2021-00053
    Event Type
    Death
    Date Received
    June 3, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 19, 2021
    Manufacturer
    ENDOLOGIX SANTA ROSA
    Product Code
    MIH
    UDI-DI
    M701TVAB3480L1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. AN EVALUATION OF THE DEVICE COULD NOT BE COMPLETED. THE DEVICE 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 SHOWS THE REPORTED TYPE IA ENDOLEAK, RUPTURE, CPR (CARDIOPULMONARY RESUSCITATION) AND EXPLANT ARE UNCONFIRMED. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. PROCEDURE-RELATED HARMS, DEVICE, USER, PROCEDURE, OR ANATOMY RELATEDNESS OF THIS EVENT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. HOWEVER, IT WAS REPORTED A CODA (NON- ENDOLOGIX) BALLOON WAS HELD FOR 1 MINUTE TO RESOLVE THE SMALL TYPE IA ENDOLEAK, AND IT WAS AFTER THAT THE PATIENT DECOMPENSATED (BALLOON SIZE NOT NOTED). IT IS POSSIBLE THE BALLOON RUPTURED THE AORTIC NECK, BUT THAT COULD NOT BE DEFINITELY DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. ALSO THERE WERE CALCIFICATIONS IN THE AORTIC NECK WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE FINAL PATIENT STATUS WAS REPORTED AS BEING EXPIRED. 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: G4 AWARENESS DATE, H6 EVALUATION RESULT CODES; REMOVE 3233. H6 EVALUATION RESULT CODES; REMOVE 11.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE 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.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH ONE (1) ALTO MAIN BODY AND TWO (2) OVATION IX ILIAC LIMBS. DURING THE INITIAL IMPLANT, A TYPE IA ENDOLEAK WAS NOTED AT FINAL ANGIOGRAM. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY UTILIZING A (CODA) NON-ENDOLOGIX BALLOON. HOWEVER, THE PATIENT WAS OBSERVED TO HAVE HYPOTENSION, THEN WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND THE PATIENT STABILIZED. AN AORTIC RUPTURE WAS SUSPECTED, THEREFORE THE PHYSICIAN ELECTED TO IMPLANT A GORE EXCLUDER (NON-ENDOLOGIX) CUFF. DURING DEPLOYMENT OF THE CUFF, THE CODA BALLOON WAS REMOVED, AT WHICH TIME THE PATIENT ARRESTED AGAIN. THE PHYSICIAN THEN ELECTED TO CONVERT PATIENT TO OPEN SURGERY AND THE ALTO DEVICE WAS EXPLANTED AND REPLACED WITH A GELSOFT PLUS (NON-ENDOLOGIX) PROSTHESIS. THE PATIENT THEN DECEASED WITHIN 48-HOURS OF THE INDEX PROCEDURE. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN/EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823449 ALTO MAIN BODY MIH ENDOLOGIX SANTA ROSA TV-AB3480-L FS011221-32 M701TVAB3480L1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death OVATION IX ILIAC LIMB, LOT # FS052620-09| OVATION IX ILIAC LIMB, LOT # FS090419-14| OVATION PRIME FILL POLYMER, LOT # FF121420-01| OVATION IX ILIAC LIMB, LOT # FS052620-09.| OVATION IX ILIAC LIMB, LOT # FS090419-14.| OVATION PRIME FILL POLYMER, LOT # FF121420-01.