FDA Adverse Event Death Summary report: N

Y90 SIR-SPHERES

MDR report key: 19558159 · Received June 17, 2024

Report

Report Number
MW5156323
Event Type
Death
Date Received
June 17, 2024
Date of Event
February 14, 2024
Report Date
June 5, 2024
Manufacturer
SIRTEX WILMINGTON LLC.
Product Code
NAW
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
OTHER CAREGIVERS
Health Professional
*

Narratives

Description of Event or Problem · 0

I AM THE HEALTH CARE PROXY FOR (B)(6) WHO PASSED AWAY ON (B)(6) 2024 FROM RADIATION PNEUMONITIS. WE DISCOVERED HE HAD A SOLITARY 5CM CANCEROUS TUMOR ON HIS LIVER ON (B)(6)2023 AT THE (B)(6) IN (B)(6). HE WAS PRESENTED WITH A CHOICE OF EXTERNAL RADIATION OR Y-90 RADIOBEMBOLIZATION SIR-SPHERES DELIVERED DIRECTLY TO HIS TUMOR BY DR. (B)(6). SHE INFORMED US THAT SINCE THE REST OF HIS LIVER WAS HEALTHY WITH NO CIRRHOSIS HE WAS A GOOD CANDIDATE FOR THIS "CURATIVE" TREATMENT. WE WERE EVEN WARNED NOT TO LOOK UP THIS TREATMENT ONLINE AS WE MAY SEE FALSE STORIES. THE DECISION WAS MADE TO MOVE FORWARD WITH THE Y90 TREATMENT, AT WHICH POINT (B)(6) WAS CALLED AND ASKED TO PARTICIPATE IN THE DOORWAY90 WHICH WOULD SUPPOSEDLY BE NOTHING DIFFERENT THAN NOT PARTICIPATING OTHER THAN A LITTLE MORE ATTENTION AND FOLLOW UP VISITS. HE AGREED TO PARTICIPATE AND HIS STUDY ID IS (B)(6). A CHEST CT (B)(6) 2023) WAS DONE PRIOR TO THE MAPPING PROCEDURE WHICH LISTED; SCATTERED PULMONARY NODULES MEASURING UP TO 3MM, BRONCHIECTASIS, AND CORONARY ARTERY CALCIFICATIONS. WE WERE TOLD BY DR. (B)(6) RIGHT BEFORE THE MAPPING PROCEDURE THAT HIS CHEST CT WAS GREAT AND SHOWED NO REASON NOT TO MOVE FORWARD. THE MAPPING PROCEDURE WAS COMPLETED ON (B)(6) 2024 BY DR. (B)(6). SHE REPORTED HE DID WELL AND THAT SHE WOULD NOT BE COMPLETING THE ACTUAL PROCEDURE ON (B)(6) 2024 IT WOULD BE DR. (B)(6). RESULTS OF TC-99M POST PROCEDURE CT WERE NOT REPORTED TO US, BUT LOOKED AT ON THE PORTAL SYSTEM. INTERESTINGLY WHEN I WAS LAST ABLE TO LOG INTO PORTAL, THE REPORT FOR THE PROCEDURE ON (B)(6) 2024 LISTED MRI ON (B)(6) 2024 (AFTER THE FACT) AS A COMPARISON STUDY FOR Y 90 PLANNING ARTERIOGRAM. DR. (B)(6) DID NOT WRITE UP HER FINAL DOSIMETRY REPORT UNTIL (B)(6) 2024 AT 9:31 AM WHICH STATED A LUNG SHUNT FRACTION O 1.6% WAS OBSERVED AND HER CALCULATIONS ALLOWED FOR A DOSE OF 38,049 SPHERES. THIS WAS AFTER HER ORIGINAL REPORT ON (B)(6) 2024 RECOMMENDED 50,732 SPHERES. DR. (B)(6) NEVER INTRODUCED HIMSELF WHICH WAS ODD TO US, DR. (B)(6) WAS THE RESIDENT WHO PERFORMED PROCEDURE ON (B)(6) 2024. THE PRESCRIBED DOSE WRITTEN UP BY DR. (B)(6) AND AGREED WITH BY DR. (B)(6) WAS 54 MCI Y-90 SIR-SPHERES, DRAWN DOSE; 56 MCI Y-90 SPHERES, DELIVERED DOES: 54.88 MCI Y-90 SIR-SPHERES. THE POST Y90 PET CT 1 HOUR LATER SHOWED THE LEFT LOBE OF THE LUNG HAVING BACKGROUND ACTIVITY-NO DEFINITE LUNG SHUNT. PERHAPS THESE SHOULD BE DONE A FEW HOURS OR A DAY LATER TO OBSERVE WHERE THE SPHERES ACTUALLY GO. AS (B)(6) DID WELL FOR 3 WEEKS POST PROCEDURE UNTIL HE DEVELOPED CONFUSION, FATIGUE, ANOREXIA, RESPIRATORY SYMPTOMS. HE WAS SO CONFUSED I BROUGHT HIM TO URGENT CARE ON (B)(6) 2024 THINKING IT COULD BE UTI RELATED WHERE THEY ASKED IF HE HAD COPD SINCE HIS O2 SAT WAS BELOW 90. I MENTIONED SEEING BRONCHIECTASIS, THEY DIDN'T REALLY THINK MUCH OF IT AND PRESCRIBED AN ANTIBIOTIC FOR UTI UNTIL CULTURE CAME BACK GIVEN HIS LEVEL OF SYMPTOMS. WE WENT TO LIVER TUMOR CLINIC FOR 1 MONTH FOLLOW UP ON (B)(6) 2024 WHERE WE WERE SEEN BY DR. (B)(6) WHO COULD NOT SEEM ANY LESS CONCERNED WITH THE REPORTED SYMPTOMS, LABS SHOWING CONCERNING RESULTS, O2 SATS STILL LOW, AND AN 11 LB WEIGHT LOSS FROM PRIOR WEEK. I ACTUALLY SAID I WAS CONCERNED FOR HIS LIFE IF I BROUGHT (B)(6) HOME AND WAS NOT TAKEN SERIOUSLY. I BROUGHT HIM TO ER IN (B)(6) BID THE NEXT DAY ONCE UTI CULTURES CAME BACK NEGATIVE. O2 SATS WERE LOW THEN, HE WAS IMMEDIATELY PUT ON OXYGEN, BROAD SPECTRUM ANTIBIOTICS, CHEST X-RAY SHOWED PATCHY CONSOLIDATION IN LOWER LOBES WHICH WAS TREATED AS PNEUMONIA. HE REMAINED IN HOSPITAL FOR 2 DAYS AND WENT HOME ON AZITHROMYCIN. FOLLOW UP X-RAYS STILL SHOWED CONCERN FOR PNEUMONIA, SO PCP PRESCRIBED 2 MORE ROUNDS OF AZITHROMYCIN WHICH DUE TO ANTI INFLAMMATORY NATURE HELD OFF THE PNEUMONITIS ALONG WITH CORTICOSTEROID INHALER. AFTER ONE WEEK OFF AZITHROMYCIN BY (B)(6) 2024 SHORTNESS OF BREATH, AND DRY COUGH CAME BACK RAPIDLY. HOSPITALIZED (B)(6), INTUBATED (B)(6), DIED (B)(6) FROM RADIATION PNEUMONITIS. I HAVE ALL TEST RESULTS I CAN PROVIDE YOU WITH TO REVIEW, BIDMC DOORWAY STUDY DRS FAILED TO ACKNOWLEDGE THE POSSIBILITY OF A LISTED POSSIBLE ADVERSE EVENT- I RESEARCHED AND BROUGHT RADIATION PNEUMONITIS TO THEIR ATTENTION AND THEY DENIED THE POSSIBILITY. THEY EVEN CALLED (B)(6) TO TELL THE ICU TEAM THEY FELT IT WAS NOT PNEUMONITIS FOR SOME REASONS UNKNOWN TO US.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2262600 Y90 SIR-SPHERES MICROSPHERES RADIONUCLIDE NAW SIRTEX WILMINGTON LLC.

Patients

Seq Age Sex Outcome Treatment
1 81 YR Male Hospitalization| D