FDA Adverse Event Death Summary report: N

SIR-SPHERES Y90 RESIN

MDR report key: 19605636 · Received June 24, 2024

Report

Report Number
MW5156539
Event Type
Death
Date Received
June 24, 2024
Date of Event
February 14, 2024
Report Date
June 20, 2024
Manufacturer
SIRTEX MEDICAL PTY LTD.
Product Code
NAW
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

PATIENT WAS TREATED WITH SIRTEX SIR-SPHERES Y90 FOR SINGLE LIVER TUMOR HCC ON (B)(6) 2024. MAPPING PROCEDURE WAS DONE ON (B)(6) 2024. PATIENT HAD LITTLE SIDE EFFECTS FOR 3 WEEKS POST TREATMENT. EARLY (B)(6) HE DEVELOPED A COUGH, DYSPNEA, AND SEVERE CONFUSION/ PERSONALITY CHANGES. THE PATIENT WAS ACTING SO OUT OF SORTS THAT GIVEN HIS AGE OF 81 FAMILY FELT HE MAY HAVE A UTI AND BROUGHT HIM TO URGENT CARE. INITIAL URINE TEST SHOWED NO UTI BUT HE WAS GIVEN AN ANTIBIOTIC IN INTERIM UNTIL CULTURE CAME BACK GIVEN LEVEL OF CONFUSION. HE WAS ALSO ASKED IF HE HAD COPD GIVEN LOW O2 LEVELS. PT STOPPED EATING AND HAD LITTLE TO NO FLUIDS FOR 6 DAYS STRAIGHT. SAW IR TEAM AT BIDMC LIVER TUMOR CLINIC FOR FOLLOW UP ON (B)(6) 2024. HE PASSED COGNITIVE EXAM FROM THE IR DR WHO HAD NEVER MET HIM BEFORE DESPITE GRAVE CONCERN FROM THIS HCP AND WIFE BOTH STATING HE WAS NOT ACTING RIGHT IN ANY WAY. THEY SAID THEY MIGHT CONSIDER HEPATIC ENCEPHALOPATHY BUT "THE REST OF HIS LIVER WAS HEALTHY SO IT CAN'T BE THAT". SENT HOME ON THE ANTIBIOTIC URGENT CARE PRESCRIBED FOR UTI. UPON RETURN TO HOUSE FROM CLINIC, URGENT CARE REPORTED THAT THE CULTURE WAS NEGATIVE AND TO STOP ANTIBIOTIC. PATIENT HAD LOST 13 POUNDS IN 7 DAYS AND WAS BROUGHT TO LOCAL ER THE NEXT DAY AS HE WAS STILL CONFUSED, NOT EATING, AND COUGHING. ER DRS IMMEDIATELY PUT HIM ON OXYGEN THERAPY, BLOOD WORK SHOWED HEIGHTENED AMMONIA LEVELS AND GIVEN PERSONALITY CHANGES AND CONFUSIONS PRESCRIBED LACTULOSE FOR HEPATIC ENCEPHALOPATHY. ALSO BEGAN TREATING PNEUMONIA AS CHEST X-RAY SHOWED OPACITIES IN LOWER LOBES. AZITHROMYCIN, AND BROAD SPECTRUM ANTIBIOTICS WERE USED. PATIENT RESPONDED WELL TO THESE AND WAS DISCHARGED 2 DAYS AFTER BEING ADMITTED. HE CONTINUED 2 MORE ROUNDS OF AZITHROMYCIN SINCE FOLLOW UP CHEST X-RAYS SHOWED CONTINUED OPACITIES IN THE LUNGS. HE WAS ALSO PRESCRIBED ALBUTEROL INHALER FOR BREATHING. THESE TWO ANTI INFLAMMATORY MEASURES MADE LIFE SUSTAINABLE FOR 2 WEEKS IN (B)(6) WHERE HE SEEMED TO GET BACK TO 80% NORMAL LIFE. LIVER TUMOR CLINIC DENIED HE COULD HAVE HAD HEPATIC ENCEPHALOPATHY BUT OFFERED NO OTHER EXPLANATION OTHER THAN CONFUSION FROM PNEUMONIA. HOWEVER THIS PT NEVER HAD A PNEUMONIA. ALL CULTURES WERE NEGATIVE, FUNGAL, BACTERIAL, ETC. AFTER COMPLETING 3RD ROUND OF AZITHRO HE HAD RAPID DECLINE IN BREATHING IN EARLY (B)(6). PUT ON HOME OXYGEN, FIRST VISIT TO PULMONOLOGIST WHO NOTED THAT HE HAD BRONCHIECTASIS LISTED AS A LUNG CONDITION FROM (B)(6) 2023. THIS SHOULD HAVE EXCLUDED HIM FROM Y90? HIS BREATHING AND 02 LEVELS DID NOT GET BETTER WITH HOME OXYGEN AND THIS HCP FOUND RADIATION PNEUMONITIS LISTED AS POSSIBLE SIDE EFFECT IN DOORWAY90 STUDY PACKET WHICH HE WAS A PARTICIPANT IN. THE IR DR'S WHO REPORT ON THIS STUDY AND WHOM WE WERE SUPPOSED TO REPORT THE ADVERSE EVENTS TO AGAIN DID NOTHING AND DENIED IT WAS POSSIBLE FOR HIM TO HAVE RADIATION PNEUMONITIS. HOWEVER, HE WAS ADMITTED TO ICU AT BID PLYMOUTH ON (B)(6) 2024. THEY RULED OUT ANY OTHER POSSIBILITY DURING HIS 2 WEEKS PLUS STAY WHERE HE WAS INTUBATED AND EVENTUALLY DIED DUE TO RADIATION PNEUMONITIS. SINCE HE PASSED ALL MAPPING AND IT'S CLAIMED THEY DID THE PROCEDURE CORRECTLY, SIR SPHERES RESIN Y90 MICRO SPHERES ARE RANDOMLY LETHAL AND LEAD TO THIS PATIENTS DEATH. THEY SHOULD BE IMMEDIATELY TAKEN OFF THE MARKET AND I WILL PURSUE EVERY AVENUE TO GET THIS DONE. I HAVE EXTENSIVE TEST RESULTS AND REPORTS TO PROVE THE ABOVE STORYLINE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1751659 SIR-SPHERES Y90 RESIN MICROSPHERES RADIONUCLIDE NAW SIRTEX MEDICAL PTY LTD. Y90 RESIN MICROSPHERE

Patients

Seq Age Sex Outcome Treatment
1 81 YR Male Life Threatening| H| D