Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Unintended Radiation Exposure (4565)
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Event Date 12/06/2020 |
Event Type
Injury
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Event Description
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Proactif clinical study it was reported that this patient was hospitalized and treated for pain.On (b)(6) 2020 the subject was enrolled into the proactif study and the treatment with y-90 therasphere was performed on the same day in the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii).A total of 2.206 gbq was administered to the right liver, and post-treatment dosimetry documented a strong uptake of macroaggregated albumin (maa) on tumors; doses to perfused liver was 109 gy and perfused tumor was 437 gy.On (b)(6) 2020, the subject presented with abdominal pain (7/10 scale) after radio-embolization.The patient was hospitalized for medical treatment of intravenous morphine 3 mg and oral antalgic treatment.No sign of progression or complication post-embolization.On (b)(6) 2020, the event was considered resolved and the subject was discharged from hospital.
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Manufacturer Narrative
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Mfr site zip/post code: (b)(4).
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Manufacturer Narrative
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G1.Mfr site zip/post code: gu9 8ql.
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Event Description
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Proactif clinical study: it was reported that this patient was hospitalized and treated for pain.On (b)(6) 2020 the subject was enrolled into the proactif study and the treatment with y-90 therasphere was performed on the same day in the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii).A total of 2.206 gbq was administered to the right liver, and post-treatment dosimetry documented a strong uptake of macroaggregated albumin (maa) on tumors; doses to perfused liver was 109 gy and perfused tumor was 437 gy.On (b)(6) 2020, 23 days post index procedure, the subject presented with abdominal pain (7/10 scale) after radio-embolization.The patient was hospitalized for medical treatment of intravenous morphine 3 mg and oral antalgic treatment.No sign of progression or complication post-embolization.On (b)(6) 2020, the event was considered resolved and the subject was discharged from hospital.
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Manufacturer Narrative
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G1.Mfr site zip/post code: (b)(4).
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Event Description
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Proactif clinical study it was reported that this patient was hospitalized and treated for pain.On (b)(6) 2020 the subject was enrolled into the proactif study and the treatment with y-90 therasphere was performed on the same day in the right hepatic artery (irrespective of origin) (segments v/vi/vii/viii).A total of 2.206 gbq was administered to the right liver, and post-treatment dosimetry documented a strong uptake of macroaggregated albumin (maa) on tumors; doses to perfused liver was 109 gy and perfused tumor was 437 gy.On (b)(6) 2020, 23 days post index procedure, the subject presented with abdominal pain (7/10 scale) after radio-embolization.The patient was hospitalized for medical treatment of intravenous morphine 3 mg and oral antalgic treatment.No sign of progression or complication post-embolization.On (b)(6) 2020, the event was considered resolved and the subject was discharged from hospital.Additional information was received that changed the onset of the abdominal pain to (b)(6) 2020.There was also clarification that during the pre-treatment, the dosimetry method used was standard (single compartment dosimetry) and the planned absorbed dose to total perfused tumor was 120 gy.However, the dosimetry method used post-treatment was multicompartmental and for this reason, the absorbed dose to total perfused tumor was 437 gy.
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Search Alerts/Recalls
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