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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION YTRIUM Y-90, UNII- YTTRIUM, ISOTOPE OF MASS 90 YTTRIU; MICROSPHERES RAQDIONUCLIDE

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BOSTON SCIENTIFIC CORPORATION YTRIUM Y-90, UNII- YTTRIUM, ISOTOPE OF MASS 90 YTTRIU; MICROSPHERES RAQDIONUCLIDE Back to Search Results
Catalog Number 10098-91-6 90Y
Device Problems Use of Device Problem (1670); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Cardiac Arrest (1762); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/07/2020
Event Type  Death  
Event Description
Cardiac arrest; my husband died as a result of being mislead by physician, that a humanitarian unit device, y-90, not legally approved by fda for use in hospitals or by private physicians in (b)(6) 2020, only clinical trials after being told this was the only treatment available to him.This was not true.My husband, (b)(6), was deliberately pressured into receiving this device, with the physician, dr.(b)(6), (b)(6) hospital, (b)(6), fully aware that it wasn't approve for treatment.My husband was never diagnose with hepatocellular cancer and no diagnosis test were performed before this device was implanted into his body.Please stop all use of y-90 glass microsphere treatment because of physicians using minorities to perform illegal procedure without prior approval of device.This humanitarian device was only to be use with 4000 patients with a rare inexplicable cancer.Dr, (b)(6) falsely listed this device under brachytherapy and proceeded to bill under code (b)(4), management of radiation therapy, complex, application of radiation source-(b)(4).Dr.(b)(6) never followed hospital or fda guidelines to receive approval from fda 75 days prior to using this type of treatment.Physician falsified medical record for capital gain on patients she knew was never diagnosed with liver cancer.This device has killed thousands and has not been reported.Fda cannot continue to ignore the harmful effects this device has on patients, like my husband, who was exposed to radiation poisoning.My husband was a persian gulf veteran, exposed to high radiation.The killing of innocent patients has to stop.This device should be banned for use permanently.Nuclear radiation and glass microspheres have done extensive damage of vital organs and there have been numerous deaths not reported by dr.(b)(6), who in turned, billed (b)(6) thousands of dollars for a device she knew she didn't have approval to use.According to (b)(6) university, there was no liver cancer found-they only did an mri on his thorax and no cancer was found there either.This is intentionally medical negligence and for that she was promoted to director, oncology radiation.Please do not kill another human being with this device that is not regulated after fda approval has been granted.This fda approval was initiated in march 2021 for the treatment of hepatocellular cancer.It was not approved in 2020 as dr.(b)(6) led my husband to believe it was approved.She insisted he signed that day, (b)(6) 2020 and they performed the procedure the same day.Physicians are overprescribing heparin, morphine, etc for minority patients and treating them as test animals with dangerous products such as y90 microspheres/glass microspheres.There is ethical conduct that should be in place by fda to prevent physicians for misleading minority patients into unauthorized medical treatments that they know will end their life.My husband served his country for 32 years, 8 months and was treated less than a human being, forced to take a treatment that the physician never performed medical pre-diagnostic tests before forcing this treatment.There should be such an outcry from the public, but since only a few unsuspecting minorities have been used as test animals, nothing is being done.I will pursue justice for my husband, even to the legislative congressional level until this drug is taken off the market and other humanitarian devices or treatments requiring high radiation or nuclear radiation.I filed a complaint with (b)(6) department of health as well.Dr.(b)(6) should not be able to practice medicine in any state because of her dishonesty and persuading patients who trusts their physicians to participant in such a horrible and inhumane device, which caused by husband's death and i know, thousands of others to die unnecessarily.I can't bring my husband back, but in honor of his name, i will not stop until this device is never used again.The physician never did any follow up tests.Dr.(b)(6), only had in her possession an mri of his thorax-chests area from (b)(6) university, who stated my husband did not have liver cancer.She should be held accountable for her unethical behavior and forcing an unapproved treatment nd device, such as y-90 on my husband, who didn't think he couldn't trust a doctor.She said he had to sign immediately, (b)(6) 2020, knowing she had not received fda approval to this procedure.Y-90 was not approved in the year 2020 for any use except in a clinical trial.Dr, (b)(6) knew she was not participating in a clinical trial and knowingly placed a biopsy performed months later ((b)(6) 2020) billed pediatrics specialists of (b)(6).My husband was (b)(6) years old, they took a sample of his neck and sent the biopsy to the children's cancer center.This is criminal and should never be accepted by fda to approval such a dangerous humanitarian device.Dr.(b)(6) violated ethical fda guidelines when she ordered y90 treatment on (b)(6), performed procedure on (b)(6) 2020, my husband died (b)(6) 2020 this y90 was not approved 75 days ahead for patient distribution under 10 cfr 35.3045, she violated hospital regulations, code.A licensee shall report any event resulting from intervention of a patient or human research subject in which administration of any radiation material results or will result in permanent functional damage to organs, this must happen within 75 days prior to ordering of procedure.Please consider how this deception is effecting thousands of unknowing and trusting minority patients, who are just trusting the doctors to do the right thing.Since they are not doing the right thing, it is left up to fda to justify approving such a horrible drug.Fda should not approve any drug, or device that isn't authorized to be used by medical professionals.Fda safety report id# (b)(4).
 
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Brand Name
YTRIUM Y-90, UNII- YTTRIUM, ISOTOPE OF MASS 90 YTTRIU
Type of Device
MICROSPHERES RAQDIONUCLIDE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key12129849
MDR Text Key260528558
Report NumberMW5102307
Device Sequence Number1
Product Code NAW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number10098-91-6 90Y
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Other;
Patient Age67 YR
Patient Weight77
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