FDA Adverse Event Death Summary report: N

SIR-SPHERES MICROSPHERES Y90 RESIN MICROSPHERES

MDR report key: 19712137 · Received July 9, 2024

Report

Report Number
MW5157129
Event Type
Death
Date Received
July 9, 2024
Date of Event
February 12, 2024
Report Date
July 5, 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 FOR SINGLE CANCEROUS LESION ON LIVER WITH SIRTEX Y90 SPHERES ON (B)(6) 2024. MAPPING PROCEDURE WAS PERFORMED ON (B)(6) 2024. OVER THE WEEKEND OF (B)(6) - (B)(6) 2024 PATIENT DEVELOPED SIDE EFFECTS WHICH INCLUDED SEVERE CONFUSION, ANOREXIA, EXTREME FATIGUE, AND COUGH/DYSPNEA. PT WAS BROUGHT TO INTERVENTIONAL RADIOLOGY TEAM ON (B)(6) 2024 WHO DID NOT REALLY TAKE FAMILY REPORTS OF SYMPTOMS SERIOUSLY DESPITE REPORTING HE WAS NOT EATING, DRINKING FLUIDS, AND ACTING BIZARRE. SINCE THE CULTURE FOR A UTI TEST DONE BY CLINIC TWO DAYS PRIOR HAD NOT COME BACK THE IR DR SAID TO CONTINUE WITH THAT PRECAUTIONARY ANTIBIOTIC. FAMILY SAW ON PORTAL THE NEXT DAY THAT THE PT HAD LOST 10 LBS IN ONE WEEK AND CULTURE FOR UTI CAME BACK NEGATIVE SO HE WAS BROUGHT TO LOCAL ED. ROOM O2 WAS 88 AND HE WAS PLACED ON OXYGEN, CHEST XRAY SHOWED IMAGING THAT COULD BE PNEUMONIA SO HE WAS TREATED FOR THAT AND HEPATIC ENCEPHALOPATHY. TWO DAYS ON ANTI-INFLAMMATORY AND ANTI BIOTIC MEDICATION HE WAS RELEASED HOME WITH INSTRUCTIONS FOR CLOSE FOLLOW UP. POST HOSPITALIZATION IMAGING CONTINUED TO SHOW PATCHY CONSOLIDATION SO PCP PRESCRIBED AZITHROMYCIN AND STEROID INHALER TO HELP WITH BREATHING. AZITHROMYCIN WAS PRESCRIBED TWICE- DUE TO IT'S ANTI INFLAMMATORY COMPONENT THE PT WAS ABLE TO FUNCTION SLIGHTLY BETTER FOR 10 DAYS. HE WAS SEEN BY IR DRS ON (B)(6) 2024 WHO TOLD HIM HE WAS CANCER FREE POST PROCEDURE. DESPITE HIS CONSISTENT WEIGHT LOSS AND BREATHING PROBLEMS THAT THEY DID NOT LOOK INTO AS POSSIBLE SIDE EFFECTS AT ALL. KNOWING RADIATION PNEUMONITIS WAS A POSSIBILITY THEY SHOULD HAVE BEEN ON TOP OF HIS BREATHING ISSUES THAT BEGAN 3-4 WEEKS AFTER PROCEDURE ESPECIALLY AFTER CULTURES DONE FOR PNEUMONIA AT HOSPITAL ALL CAME BACK NEGATIVE. BY (B)(6) 2024 NOTICEABLE DRY COUGH EVERY 4 WORDS WAS BACK AND ON (B)(6) 2024 PCP ORDERED ANOTHER CHEST XRAY. SEEN BY PCP ON (B)(6) 2024 WHO SAID PNEUMONIA WAS NO LONGER LIKELY DUE TO NEGATIVE CULTURES, MULTIPLE ROUNDS OF ANTIBIOTICS, AND DRY COUGH. PCP REPORTED THAT CHEST XRAY SHOWED WORSENING GROUND GLASS OPACITY AND MULTIFOCAL AIRSPACE DISEASE. PCP GOT PT INTO PULMONOLOGIST ON (B)(6) 2024 WHO PRESCRIBED HOME OXYGEN DUE TO ROOM O2 BEING 86%, FAILED PFT, AND REPORTED THAT BRONCHIECTASIS WAS NOTED ON CHEST XRAY FROM (B)(6) 2023. IMAGING WAS ORDERED TO RULE OUT PULMONARY EMBOLISM THAT WAS DONE ON (B)(6) 2024 WHICH WAS NEGATIVE. (B)(6) 2024 THIS HCP FOR PT UPON OWN RESEARCH IN MEDICAL JOURNALS AND READING THE POSSIBLE SIDE EFFECTS FROM DOORWAY90 STUDY PT WAS A PARTICIPANT IN, ALERTED PCP, PULMONOLOGIST, AND IR TEAM IN BOSTON THAT I BELIEVED HE WAS SUFFERING FROM RADIATION PNEUMONITIS. IR TEAM HAD HIM GO TO BOSTON (6HOUR ROUND TRIP) TO TELL HIM THEY DIDN'T THINK IT WAS RP EVEN THOUGH THEY DID NOT LISTEN TO HIS LUNGS OR EXAMINE HIM IN ANY WAY AT THE APPOINTMENT. WHEN ASKED DIRECTLY WHAT ELSE THIS COULD BE SEEING HIS CULTURES WERE NEGATIVE, ANTIBIOTICS HAD DONE NOTHING, SYMPTOMS WORSENING, AND NO PE DR (B)(6) JUST SHRUGGED HER SHOULDERS. SHE SAID SHE WOULD CALL IN 20 MG OF PREDNISONE IF HE FELT LIKE HE NEEDED IT. PT NORMALLY COULD WALK GOING TO THESE APPTS, AT THIS ONE HE COULDN'T TAKE MORE THAN 4 STEPS WITHOUT WHEELCHAIR. CONTINUED TO DECLINE AT HOME WAITING FOR STEROIDS TO BE CALLED IN, THEY NEVER WERE. FAMILY DECIDED TO BRING HIM TO LOCAL ED ON (B)(6) 2024. ADMITTED TO ICU IMMEDIATELY WITH HIGH PRESSURE OXYGEN ASSISTANCE AND STEROIDS. INTUBATED ON (B)(6) 2024 WHERE A SCOPE WAS PERFORMED TITLED PNEUMONITIS V PNEUMONIA. NO PNEUMONIA FOUND IN SCOPE OR ANY CULTURES AGAIN. TREATMENT FOR RP AND HIGH DOSE STEROIDS BEGAN (B)(6) 2024 FOR 3 DAYS. PT DID SLIGHTLY BETTER BREATHING DURING THIS AND ATTEMPT TO TAKE OF VENTILATOR WAS DONE ON 4/21 LASTED 2 DAYS BEFORE DECLINE. PT SHOWED NO HOPE FOR IMPROVEMENT AND DIED DUE TO RADIATION PNEUMONITIS AS NOTED ON DEATH CERTIFICATE (B)(6) 2024.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2385711 SIR-SPHERES MICROSPHERES Y90 RESIN MICROSPHERES MICROSPHERES RADIONUCLIDE NAW SIRTEX MEDICAL PTY LTD SIR-Y001 SA028V03

Patients

Seq Age Sex Outcome Treatment
1 NA Male Death ALBUTEROL .| ALLOPURINOL .| CHOLECALCIFEROL .| GEMFIBROZIL .| LISINOPRIL .| LORAZEPAM .| METFORMIN.| SIMVASTATIN .