Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED SIR-SPHERES® Y-90 RESIN MICROSPHERES Back to Search Results
Lot Number MG410V05
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 08/28/2018
Event Type  Injury  
Manufacturer Narrative
The adverse event of superinfection (verbatim: possible superinfection of cavities after radioembolization) was classified as serious since the event led to hospitalization/prolongation of hospitalization of a (b)(6) male patient about six weeks after sir-spheres microspheres had been administered.The patient had not received nivolumab.Superinfection is expected in terms of infection for mapping and implant procedures and unexpected for sir-spheres microspheres.Considering that the patient suffered from infection starting four days after administration of sir-spheres microspheres, the temporal relationship of superinfection is plausible for sir-spheres and related procedures.The patient had been admitted to hospital shortly after implantation due to infection and tumour necrosis, which can be attributed to the mode of action of sir-spheres microspheres.Since necrotic tissue provides an optimal breeding ground for infections, tumour necrosis may have facilitated development of infection.The current event of superinfection probably occurred following this first infection and the patient's compromised condition due to the underlying disease and the preceding infection might have facilitated development of superinfection.Enterococcus faecium was identified in samples, however, the pathogen responsible for the first infection remains still unclear as well as it was not confirmed that superinfection concerned the abdominal cavity and no details on the event course have been reported yet.The investigator assessed the event as definitely related to sir-spheres microspheres, mapping and implant procedures.Based on the information available, the sponsor assessed the event as possibly related to mapping and implant procedure as well as sir-spheres microspheres since a contributing role via tumour necrosis is considered possible.
 
Event Description
This case report combines information received on 29-aug-2018 and 05-sep-2018.A serious adverse event report, ((b)(4)), was received from an investigator in spain regarding a male patient ((b)(6)) enrolled in (b)(6).This case is linked to (b)(4) ("infection from tumoral necrosis"), reported to fda as 3005579300-2018-00006.Initial report was received on 29-aug-2018: the reported event term was "possible superinfection of cavities after radioembolization".At the time of the event onset the patient was (b)(6).The patient's medical history was significant for hepatocellular carcinoma, arterial hypertension, and biliary fistula (since (b)(6) 2017), all ongoing.Concomitant medication included amlodipine, 5 mg, oral and losartan, 150 mg, oral, both since 2016 for arterial hypertension, daivobet (betamethasone), 50 ug, oral, for unknown indication, and paracetamol, unknown dosage, oral, for pain prophylaxis.At the time of the event the patient had received sir-spheres microspheres only.Treatment with chemotherapy agent (nivolumab) was not yet started.Mapping procedure and implantation of sir-spheres microspheres (batch number unknown) was performed on (b)(6) 2018.On (b)(6) 2018, the patient presented with "possible superinfection of cavities after radioembolization" and was hospitalised.The event was severe.The following description was provided by the investigator: "in extracted sample positive to enterococcus faecium.Drainage catheter implant to (b)(6) 2018".For relevant laboratory results, see structured information.The patient was treated with piperazilin/tazobactam, 16 g, intravenous, start date (b)(6) 2018, ongoing, and received a transfusion, dose was provided as "2", intravenous, on (b)(6) 2018.At the time of this report, the event was ongoing.Reporter's comments: the investigator assessed the event as definitely related to the sir-spheres microspheres (mapping procedure), as definitely related to the sir-spheres microspheres (implant procedure), and as definitely related to sir-spheres microspheres (medical device).
 
Manufacturer Narrative
The adverse event of superinfection: possible superinfection of cavities after radioembolization) was classified as serious since the event led to hospitalization/prolongation of hospitalization of a 58-year old male patient about six weeks after sir-spheres microspheres had been administered.The patient had not received nivolumab.Superinfection is expected in terms of infection for mapping and implant procedures and unexpected for sir-spheres microspheres.Considering that the patient suffered from infection starting four days after administration of sir-spheres microspheres, the temporal relationship of superinfection is plausible for sir-spheres and related procedures.The patient had been admitted to hospital shortly after implantation due to infection and tumour necrosis, which can be attributed to the mode of action of sir-spheres microspheres.Since necrotic tissue provides an optimal breeding ground for infections, tumour necrosis may have facilitated development of infection.The current event of superinfection probably occurred following this first infection and the patient's compromised condition due to the underlying disease and the preceding infection might have facilitated development of superinfection.Enterococcus faecium was identified in samples, however, the pathogen responsible for the first infection remains still unclear as well as it was not confirmed that superinfection concerned the abdominal cavity and no details on the event course have been reported yet.The investigator assessed the event as definitely related to sir-spheres microspheres, mapping and implant procedures.Based on the information available, the sponsor assessed the event as possibly related to mapping and implant procedure as well as sir-spheres microspheres since a contributing role via tumour necrosis is considered possible.With follow-up information received on 13-sep-2018, it was clarified that superinfection in cavities refers to the hepatic cavity and that the infection manifested as liver abscess from which drainage the pathogens e.Faecium and candida albicans were extracted.Noteworthy perihepatic abscess formation is expected for sir-spheres microspheres, thus the expectedness is amended from unexpected to expected after this specification.The tumour necrosis, which is a desired effect of sirt likely promoted development of liver abscess.Overall, the sponsor's causality assessment remains unchanged as possibly related to sir-spheres microspheres and related procedures.
 
Event Description
This case report combines information received on 29-aug-2018 and 05-sep-2018.A serious adverse event report, (case number: (b)(4), was received from an investigator in spain regarding a male patient (patient no: (b)(6) enrolled in "a multicenter, open-label, single-arm study of the safety and antitumoral efficacy of nivolumab after selective internal radiation therapy (sirt) using sir-spheres for the treatment of patients with hepatocellular carcinoma that are candidates for locoregional therapies (nasir-hcc)", study code: (b)(4).This case is linked to case number: (b)(4) ("infection from tumoral necrosis"), reported to fda as 3005579300-2018-00006.Initial report was received on 29-aug-2018: the reported event term was "possible superinfection of cavities after radioembolization".At the time of the event onset the patient was 58-year-old.The patient's medical history was significant for hepatocellular carcinoma, arterial hypertension, and biliary fistula (since on (b)(6) 2017), all ongoing.Concomitant medication included amlodipine, 5 mg, oral and losartan, 150 mg, oral, both since 2016 for arterial hypertension, daivobet (betamethasone), 50 g, oral, for unknown indication, and paracetamol, unknown dosage, oral, for pain prophylaxis.At the time of the event the patient had received sir-spheres microspheres only.Treatment with chemotherapy agent (nivolumab) was not yet started.Mapping procedure and implantation of sir-spheres microspheres (batch number: unknown) was performed on (b)(6) 2018.On (b)(6) 2018, the patient presented with "possible superinfection of cavities after radioembolization" and was hospitalised.The event was severe.The following description was provided by the investigator: "in extracted sample positive to enterococcus faecium.Drainage catheter implant to on (b)(6) 2018".For relevant laboratory results, see structured information.The patient was treated with piperazilin/tazobactam, 16 g, intravenous, start date on (b)(6) 2018, ongoing, and received a transfusion, dose was provided as "2", intravenous, on (b)(6)2018.At the time of this report, the event was ongoing.Follow-up information was received on 13-sep-2018: the batch number for sir-spheres microspheres implanted was provided as mg410v05.The investigator amended the initial statement "in extracted sample positive to enterococcus faecium and candida albicans".It was clarified that "superinfection in cavities" referred to the hepatic cavities and that enterococcus faecium possibly caused the superinfection.The drainage was located in liver abscess, the pathogen was extracted from the "liver abscess to drainage".There was no evidence of biliary fistula.For reported laboratory results, please refer to structured information.Reporter's comments: the investigator assessed the event as definitely related to the sir-spheres.Microspheres (mapping procedure), as definitely related to the sir-spheres.Microspheres (implant procedure), and as definitely related to sir-spheres.Microspheres (medical device).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SIR-SPHERES® Y-90 RESIN MICROSPHERES
Type of Device
MICROSPHERES
Manufacturer (Section D)
SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED
level 33
101 miller street
north sydney, 2060
AS  2060
MDR Report Key7876230
MDR Text Key120244187
Report Number3005579300-2018-00007
Device Sequence Number1
Product Code NAW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup
Report Date 09/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberMG410V05
Date Manufacturer Received09/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMLODIPINE; AMLODIPINE; BETAMETHASONE; BETAMETHASONE; LOSARTAN; LOSARTAN; PARACETAMOL; PARACETAMOL; AMLODIPINE; BETAMETHASONE; LOSARTAN; PARACETAMOL
Patient Outcome(s) Hospitalization;
Patient Age58 YR
-
-