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Lot Number 1799135/37
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891); Cancer (3262)
Event Date 05/25/2017
Event Type  Injury  
Manufacturer Narrative
Clarification was received from the administering physician that there was no change in spleen size upon exam and the intracerebral bleed and decreased platelet count was not related to the therasphere. There was no device malfunction reported. It should be noted that liver dominant neuroendocrine carcinoma is an off label indication for therasphere use. No additional information will be reported in association with this case.
Event Description
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.
Event Description
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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Manufacturer (Section D)
farnham business park
weydon lane
farnham, surrey GU9 8 QL
Manufacturer (Section G)
farnham business park
weydon lane
farnham, surrey GU9 8 QL
Manufacturer Contact
sandra bausback
300 four falls corp cntr - 380
300 conshohocken st. rd.
west conshohocken, PA 19428-2998
MDR Report Key6653312
MDR Text Key120879540
Report Number3002124543-2017-00034
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number1799135/37
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/20/2017 Patient Sequence Number: 1