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This is a follow up submitted to report additional information received from the administering physician on (b)(6) 2018.
Refer to initial report for the event description as reported by the er physician.
Following the submission of an annual report to the fda on 23 feb 2018, the fda requested additional detailed patient and procedure information to aid in reviewing the saes reported in the annual update.
The request for additional information was sent to the administering physician via email on 20 mar 2018.
A response from the administering physician was received on 09 apr 2018 via a phone conversation stating that he did not agree with the assessment of spleen atrophy made by the reporting er physician.
In the administering physician's opinion, the spleen did not change on physical exam.
The physician stated that in his opinion, as the administering physician, he does not attribute the event of intracerebral bleed and low platelets to be associated with the therasphere treatment.
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Small spleen [spleen atrophy] brain bleed/intra-cerebral bleed [cerebral haemorrhage] platelet count of 12 [platelet count decreased] liver dominant neuroendocrine carcinoma [off label use of device] case description: initial information received on 25-may-2017: this spontaneous medical device report was received from a physician concerning a patient of an unknown age and gender.
The patient's medical history included liver dominant neuroendocrine carcinoma, since an unknown date.
The patient's concomitant medications were not reported.
The patient received 2 x 17.
5 gbq of therasphere (lot number: 1799135/1799137, expiration dates not reported) on (b)(6) 2017, for liver dominant neuroendocrine carcinoma [off label use of device].
The patient was treated sub lobar, bi-segmental, 120gy from the right common femoral artery (rcfa).
On (b)(6) 2017, two weeks after the treatment, the patient presented to the emergency room with an intra-cerebral bleed [cerebral haemorrhage].
The lab results showed a platelet count of 12 [platelet count decreased] and the abdominal imaging showed a small spleen [spleen atrophy].
The treatment and the outcome of the events were unknown.
The reporting physician did not assess the severity, seriousness and causality of the events to therasphere.
He was rather looking for information and other experiences.
However, the emergency department (ed) physician had attributed the bleed to the therasphere.
The company considered the events cerebral haemorrhage, platelet count decreased, spleen atrophy as serious and the event off label use of device as non-serious.
Follow up information was sought to further investigate the events but at the time of this report, no new information had been received.
After three follow-up attempts, the case was considered lost to follow up.
This case is final.
Company comments: cerebral haemorrhage and platelet count decreased were considered anticipated according to therasphere current reference safety information whereas the events spleen atrophy and off label use of device were considered unanticipated.
In the absence of an assessment made by the reporting physician, the company considered that it is very likely that the spleen atrophy is a consequence of therasphere treatment.
It is very likely that the low platelet count is a consequence of spleen atrophy, and it is very likely that the cerebral bleeding is a consequence of the low platelet count.
However, other factors should be taken into account i.
E.
Other anti-cancer therapy was ongoing or stopped before the treatment with therasphere (bevacizumab, sunitinib, everolimus) which could be implicated in the cerebral vascular malformation.
Also, misadministration of therasphere could have been a contributory factor i.
E.
Administration of therasphere into the spleen artery (vascular spasm, reflux during the procedure).
The high activity delivered, the size of the tumour, the situation of the tumour could all be contributory factors to the reported events.
Without further information it is difficult to give an accurate assessment.
The company considered off label use of device not an adverse event per se but a special scenario and therefore not assessable.
This single case report does not modify the risk benefit balance of therasphere.
The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
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