BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX ALTO STENT GRAPH DEVICE, EVAR ENDOLOGIX CUSTOM SEAL KIT

    MDR report key: 24389276 · Received February 19, 2026

    Report

    Report Number
    MW5184084
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 13, 2026
    Manufacturer
    ENDOLOGIX LLC.
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ENDOLOGIX ALTO STENT GRAPH DEVICE DEFECT. KIT LOT: FF041425-01, REF: TV-CS14-G. MY MOTHER, (B)(6), HAD THIS DEVICE PUT IN ON (B)(6) 2026 TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. THE DEVICE HAD AN ENDO LEAK WITH A RUPTURED POLYMER RING RESULTING IN THE POLYMER MATERIAL GOING INTO MY MOTHER'S BODY. SHE WENT INTO ANAPHYLACTIC SHOCK; HER BLOOD PRESSURE WENT DOWN TO SEVERELY DANGEROUS LEVELS. SHE COULDN'T BREATHE ON HER OWN AND HAD TO BE PUT ON A VENTILATOR, SHE WAS NON-RESPONSIVE FOR OVER 24 HOURS. SHE IS SLOWLY RECOVERING BUT HAS SUSTAINED HEALTH COMPLICATIONS THAT HER SURGEON (DR. PABST) AND ALL MEDICAL STAFF ARE UNCERTAIN OF THE OUTCOME AS FAR AS HOW MUCH HER MEDICAL CONDITION WILL IMPROVE. SHE HAS SUFFERED KIDNEY DAMAGE, BLADDER ISSUES, HER BLOODWORK RESULTS ARE STILL OUT OF THE NORMAL RANGE, SHE HAS LOST FEELING IN BOTH OF HER FEET, SHE HAS SEVERE FOOT DROP AND CAN NOT WALK ON HER OWN, IMMEDIATELY UPON COMPLETION OF THE SURGERY SHE DEVELOPED SEVERE BRUISING OVER HER ENTIRE BUTTOCKS AND DOWN THE BACK OF HER LEGS WHICH I WAS TOLD WAS FROM THE POLYMER MATERIAL THAT LEAKED. NOW THIS BRUISING HAS TURNED TO OPEN SORES. SHE HAS HAD TO HAVE SEVERAL BLOOD TRANSFUSIONS AS A RESULT OF THIS DEFECTIVE STENT GRAPH. SHE WAS IN THE INTENSIVE CARE UNIT FOR 8 DAYS AND NOW IS ON A REGULAR HOSPITAL FLOOR BUT WILL NEED TO GO TO A REHABILITATION FACILITY FOR EXTENSIVE REHABILITATION SERVICES. SUPPOSEDLY THERE ARE ONLY 5 OTHER CASES NATIONWIDE WITH THIS SO THE MEDICAL PROFESSIONALS ARE NOT SURE WHAT HER PROGNOSIS WILL BE LONG TERM. CONSULTATION WAS MADE WITH A NEUROLOGY DEPARTMENT IN ANOTHER HOSPITAL AND THEIR CONCLUSION FROM HER MEDICAL RECORDS IS THAT SHE WILL NOT EVER BE ABLE TO WALK ON HER OWN AGAIN. SHE IS STILL IN THE HOSPITAL AND WILL BE TRANSFERRED TO THE REHABILITATION FACILITY WHEN SHE IS MEDICALLY READY TO GO. SO FAR, WE HAVE NOT BEEN TOLD HOW LONG SHE WILL REMAIN IN THE HOSPITAL. PRIOR TO HER SURGERY SHE WAS VERY ACTIVE, WALKED ON HER OWN, TOTALLY INDEPENDENT. MY MOTHER HAS HAD SEVERAL CT SCANS, EKG TESTS AND SEVERAL BLOOD TESTS DONE. IT IS HARD TO INCLUDE THEM ALL. I HAVE PRINTED ALL HER TESTS AND RESULTS OUT. IF THEY ARE NEEDED, I WOULD BE MORE THAN HAPPY TO PROVIDE THEM TO YOU. PLEASE REACH OUT TO ME AT (B)(6) OR (B)(6). I AM NOT SURE OF THE MODEL NUMBER, CATALOG NUMBER OR UDI IF YOU NEED THESE NUMBERS, PLEASE LET ME KNOW AND I WILL DO MY BEST TO GET THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425000 ENDOLOGIX ALTO STENT GRAPH DEVICE, EVAR ENDOLOGIX CUSTOM SEAL KIT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH ENDOLOGIX LLC. TV-CS14-G FF041425-01

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| L| S| R FLUOXETINE.| LISINOPRIL-HYDROCHLORIDE.| ROPINIROLE AT BEDTIME.| SYNTHROID.| TYLENOL.