THERASPHERES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-02 for THERASPHERES manufactured by Mds Nordio.

Event Text Entries

[2606243] This is an initial report. Pt cf was a (b)(6) female with a history of metastatic carcinoid tumor with liver metastases. She was initially diagnosed in (b)(6) 2012, after presenting with significant weight loss and diarrhea. Percutaneous liver biopsy performed (b)(6) 2010 was consistent with pleomorphic carcinoma with neuroendocrine differentiation. In (b)(6) 2010, her follow-up scan revealed slight disease progression in the liver metastases and she was started on sandostatin in (b)(6) 2010. It initially improved her diarrhea, however she began having significant abdominal pain. She elected to undergo a small bowel resection with ileocecal anastomosis on (b)(6) 2011. Post-op, her pain seemed to be improved but her diarrhea became worse. Her sandostatin was increased with little relief and therefore she sought out alternative treatment options. She initially presented to interventional radiology on (b)(6) 2011, during which time she elected to enroll in the theraspheres protocol (b)(4) (radioembolization with yttrium-90). She underwent treatment to both the right and left lobes on (b)(6) 2011, respectively. She was last seen in clinic (b)(6) 2012 for interval follow-up. She was doing relatively well but her symptoms remain unchanged. She still continued to complain of abdominal pain, rectal pressure and increased diarrhea following her sandostatin injection and post prandial. She stated she was uncomfortable the entire month which she attributes to the sandostatin. She took lomotil and imodium with little relief. She complained of significant lower extremity swelling. She was wearing prescription compression stocking and taking diuretics with little relief. The pt's sister called (b)(6) 2012, to report that (b)(6) had died at 12:00pm. She stated that the pt was admitted to (b)(6), secondary to palpitations and anemia. She received blood products but "arrested" twice. She was mechanically ventilated until (b)(6) 2012, when it was discontinued and she died. We will obtain records from her hospitalization and submit that as the final report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2545210
MDR Report Key2545210
Date Received2012-04-02
Date of Report2012-04-02
Date of Event2012-03-30
Date Added to Maude2012-04-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHYSICIAN ASSISTANT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTHERASPHERES
Generic NameY90 GLASS BEADS FOR RADIOEMBOLIZATION
Product CodeIWA
Date Received2012-04-02
Device AvailabilityN
Device AgeDA
Device Sequence No1
Device Event Key0
ManufacturerMDS NORDIO
Manufacturer AddressOTTAWA CA


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2012-04-02

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