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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED SIR-SPHERES® Y-90 RESIN MICROSPHERES

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SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED SIR-SPHERES® Y-90 RESIN MICROSPHERES Back to Search Results
Lot Number LG407V04
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Abdominal Pain (1685); Fever (1858)
Event Date 07/17/2017
Event Type  Injury  
Manufacturer Narrative
The serious adverse event of general physical health deterioration led to hospitalization of a female patient 12 days after sir-spheres microspheres mapping procedure and 4 days after implantation of sir-spheres microspheres. The sponsor conservatively assesses the temporal relationship as plausible for sir-spheres microspheres and implantation procedure, but implausible for mapping procedure. General physical health deterioration is unexpected for the sir-spheres microspheres, implantation and mapping procedure. Based on their mechanism of action sir-spheres microspheres may have led to the patient's symptoms of abdominal pain and fever, which can lead to or contribute to deterioration of general physical health. However, the patient's underlying intrahepatic cholangiocarcinoma also provides a likely explanation for the event. Noteworthy, the information provided is very limited precluding an exhaustive assessment. The case lacks information on further medical history, concomitant medication and event details. The investigator assessed the event as definitely related to sir-spheres microspheres implant procedure. No causality assessment for sir-spheres microspheres and mapping procedure was provided. Considering the plausible temporal course, the sponsor assesses the event of general physical health deterioration as possibly related to sir-spheres microspheres and sir-spheres microspheres implant procedure and unlikely related to sir-spheres microspheres mapping procedure. With follow-up information received on 14-aug-2017 the investigator's causality assessment for sir-spheres microspheres implant procedure and sir-spheres microspheres mapping procedure was provided as not related. The investigator's causality assessment for sir-spheres microspheres was provided as probable/likely. The sponsor's initial causality assessment remains unchanged. On 08-sep-2017, 13-sep-2017, 14-sep-2017, and 19-sep-2017 further follow-up information was provided. The investigator reported a slight dose deviation and specified the outcome of the event "deterioration of general condition" as fatigue grade 3 as sequelae. The sponsor's causality assessment remains unchanged.
 
Event Description
This report combines information received between 18-jul-2017 and 18-sep-2017. This is the initial medical device report to the fda. A serious adverse event report was received on 18-jul-2017 from an investigator in (b)(6) regarding a female patient ((b)(6)) enrolled in "a (b)(6) study evaluating sir-spheres® y-90 resin microspheres preceding standard cisplatin-gemcitabine (cis-gem) chemotherapy versus cis-gem chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma (sircca)", study (b)(6). The reported event term was "deterioration of general condition". No relevant medical history or concomitant medication was reported. The patient received a combined modality treatment of sir-spheres microspheres + cis-gem chemotherapy. Mapping procedure was performed on (b)(6) 2017, implantation of sir-spheres microspheres (batch number lg407v04) was performed on (b)(6) 2017. Radiation dose and artery of administration were not reported. At the time of the event treatment with chemotherapy agents (cisplatin-gemcitabine) was not started. On (b)(6) 2017, the patient presented with "deterioration of general condition", "abdominal pain" and "fever" (38. 5 °c) and was hospitalised the same day. The severity of the event of "deterioration of general condition" was assessed as severe by the investigator. No other laboratory/diagnostic test results were reported. The patient was not withdrawn from the study due to this event. At the time of the initial report, the outcome was not reported. Follow-up information received on 14-aug-2017: the investigator provided the event stop date as (b)(6) 2017 and the outcome as recovered with sequelae. Follow up information received on 08-sep-2017, 13-sep-2017, 14-sep-2017, and 19-sep-2017: the investigator specified the sequelae of the patient as "fatigue grade 3". Furthermore, the investigator reported a slight dose deviation for sir-spheres microspheres. The delivered dose was slightly greater than was anticipated by 0. 14 gbq. The calculated activity of sir-spheres microspheres was 1. 29 gbq, whereas the actual implanted activity was 1. 43 gbq. The calculation for the patient dose was done correctly and the calculated dose was within the prescribed range. For the injection, the site used glucose instead of water for injection with the product. The investigator anticipated a residual volume that usually occurs when the administration is performed with water for injection but did not occur when glucose was used instead and therefore a minimal dose deviation occurred. The investigator specifically stated that the sae of "deterioration of general condition" was not related to the dose deviation. Reporter's comment: at the time of the initial report, the investigator assessed the event of "deterioration of general condition" as definitely related to sir-spheres microspheres (implant procedure). No causality assessment was provided for sir-spheres microspheres (mapping procedure) and sir-spheres microspheres (device). With follow up information received on 14-aug-2017 the investigator's causality assessment for sir-spheres microspheres (implant procedure) was changed to "not related". The causality assessment for sir-spheres microspheres (mapping procedure) was provided as "not related", the causality assessment for sir-spheres microspheres (device) was provided as "probable/likely". Please note: this report has also been submitted to the fda as ide (b)(4).
 
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Brand NameSIR-SPHERES® Y-90 RESIN MICROSPHERES
Type of DeviceMICROSPHERES
Manufacturer (Section D)
SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED
level 33
101 miller street
north sydney, 2060
AS 2060
Manufacturer Contact
level 33
101 miller street
north sydney, 2060
MDR Report Key7344852
MDR Text Key102626484
Report Number3005579300-2018-00003
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberLG407V04
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/18/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/16/2018 Patient Sequence Number: 1
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