MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW

Model Number UNKNOWN

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Radiation Overdose (1510); Abdominal Pain (1685); Abscess (1690); Fever (1858)

Event Type  Injury  

Manufacturer Narrative

Btg medical assessment: case #3: 90y-pet/ct to reveal inadvertent selective delivery of 90y-microspheres.A (b)(6) male with a grade i neuroendocrine tumor of the small bowel and multiple liver metastases, for which he already received four cycles of intravenous 7400 mbq lutetium-177 (177lu)-dotatate, was referred for radioembolization after progression of the liver metastases.The patient was planned for whole liver radioembolization with two injection positions.Proximally in the right hepatic artery (rha), injection position proximal to the segment iv branches was selected and 99mtc-maa was administered.Planar imaging found a negligible lsf (4.3%), and spect/ct showed good distribution of microspheres throughout the liver, albeit with a slightly lower deposition of activity in segment iv.Glass 90y-microspheres were injected into the predetermined positions (lha activity: 1.1 gbq, prescribed average absorbed dose 150 gy because of high tumor load; rha activity: 3.5 gbq, prescribed average absorbed dose 110 gy).90y-pet/ct revealed that almost all activity injected in the rha had landed in segment iv it is hypothesized that this was caused by preferential flow towards the nearby segment iv branch caused by an out-of-center placement of the end-hole catheter against the vessel wall.Another explanation could be the occurrence of an arterial spam, but the ts administration angiography is not documented in the article.The consequences is that the activity in segment iv was quantified at 3.4 gbq on 90y-pet/ct, which amounts to an absorbed dose of approximately 1400 gy.Shortly after treatment, the patient started experiencing severe pain in the liver area and developed a fever.An abscess had formed in the necrotic tissue in segment iv, therefore treatment with wide-spectrum antibiotics was started.Attempts to percutaneously drain the abscess were unsuccessful due to rigidity of the surrounding fibrous tissue and surgical drainage was necessary.In the following weeks, the symptoms improved, only to return 3 days after ceasing antibiotic therapy.Once again, an abscess was found in segment iv, this time the patient underwent a left hepatectomy including the abscess and necrotic tissue.The patient made a full recovery and remains alive to the date of writing this essay.This case illustrates the essence of 90y-pet/ct to assess whether the treatment was performed as planned.Subtle changes in flow or catheter position may lead to a completely different distribution.Over treatment of an hepatic segment due to an administration issue, possible an catheter placement error, or the occurrence of an arterial spam.The patient had already received a significant dose of nuclide radiation treatment.This was not considered when the treatment was planned.No device failure or malfunction.Btg medical assessment: severe abdominal pain: severity 4; serious; related to device; anticipated.Fever: severity 4; serious; related to device; anticipated.Abscess: severity 4; serious; related to device; anticipated.Over treatment of a target tissue: severity 4; serious; related device; anticipated.Malposition of the canether (device use error): severity 4; serious; not related to device; anticipated.No batch review was possible for this case as the batch number(s) could not be ascertained and the product was not returned for evaluation (devices remain implanted in the patients and information was obtained via a literature review).No product malfunction/deficiency has been identified or reported.No corrective/preventative action has been identified.Should we receive any information to enable further investigations, a follow-up report will be submitted.At this time this report is considered final.

Event Description

Review of literature article: the value of yttrium-90 pet/ct after hepatic radioembolization:a pictorial essay.Authors: ahmed a alsultan et al.Case #3: 90y-pet/ct to reveal inadvertent selective delivery of 90y-microspheres.A (b)(6) male with a grade i neuroendocrine tumor of the small bowel and multiple liver metastases, for which he already received four cycles of intravenous 7400 mbq lutetium-177 (177lu)-dotatate, was referred for radioembolization after progression of the liver metastases.The patient was planned for whole liver radioembolization with two injection positions.A suitable injection position was found in the lha and 99mtc-maa was administered.Proximally in the right hepatic artery (rha), two small medial hepatic arteries were identified, but could not be catheterized separately.Thus, an injection position proximal to the segment iv branches was selected and 99mtc-maa was administered.Planar imaging found a negligible lsf (4.3%), and spect/ct showed good distribution of microspheres throughout the liver, albeit with a slightly lower deposition of activity in segment iv.After which, the patient proceeded to treatment.Glass 90y-microspheres were injected into the predetermined positions (lha activity: 1.1 gbq, prescribed average absorbed dose 150 gy because of high tumor load; rha activity: 3.5 gbq, prescribed average absorbed dose 110 gy).90y-pet/ct revealed that almost all activity injected in the rha had landed in segment iv it is hypothesized that this was caused by preferential flow towards the nearby segment iv branch caused by an out-of-center placement of the end-hole catheter against the vessel wall.The activity in segment iv was quantified at 3.4 gbq on 90y-pet/ct, which amounts to an absorbed dose of approximately 1400 gy.Shortly after treatment, the patient started experiencing severe pain in the liver area and developed a fever.An abscess had formed in the necrotic tissue in segment iv, therefore treatment with wide-spectrum antibiotics was started.Attempts to percutaneously drain the abscess were unsuccessful due to rigidity of the surrounding fibrous tissue and surgical drainage was necessary.In the following weeks, the symptoms improved, only to return 3 days after ceasing antibiotic therapy.Once again, an abscess was found in segment iv, this time the patient underwent a left hepatectomy including the abscess and necrotic tissue.The patient made a full recovery and remains alive to the date of writing this essay.This case illustrates the essence of 90y-pet/ct to assess whether the treatment was performed as planned.Subtle changes in flow or catheter position may lead to a completely different distribution.

Manufacturer Narrative

Additional information received from author 03-dec-2019 including associated batch number.A device history review will be performed and our final findings will be submitted in a supplemental report.

Event Description

Review of literature article: the value of yttrium-90 pet/ct after hepatic radioembolization:a pictorial essay.Authors: ahmed a alsultan et al.Case #3: 90y-pet/ct to reveal inadvertent selective delivery of 90y-microspheres.A 68-year-old male with a grade i neuroendocrine tumor of the small bowel and multiple liver metastases, for which he already received four cycles of intravenous 7400 mbq lutetium-177 (177lu)-dotatate, was referred for radioembolization after progression of the liver metastases.The patient was planned for whole liver radioembolization with two injection positions.A suitable injection position was found in the lha and 99mtc-maa was administered.Proximally in the right hepatic artery (rha), two small medial hepatic arteries were identified, but could not be catheterized separately.Thus, an injection position proximal to the segment iv branches was selected and 99mtc-maa was administered.Planar imaging found a negligible lsf (4.3%), and spect/ct showed good distribution of microspheres throughout the liver, albeit with a slightly lower deposition of activity in segment iv.After which, the patient proceeded to treatment.Glass 90y-microspheres were injected into the predetermined positions (lha activity: 1.1 gbq, prescribed average absorbed dose 150 gy because of high tumor load; rha activity: 3.5 gbq, prescribed average absorbed dose 110 gy).90y-pet/ct revealed that almost all activity injected in the rha had landed in segment iv it is hypothesized that this was caused by preferential flow towards the nearby segment iv branch caused by an out-of-center placement of the end-hole catheter against the vessel wall.The activity in segment iv was quantified at 3.4 gbq on 90y-pet/ct, which amounts to an absorbed dose of approximately 1400 gy.Shortly after treatment, the patient started experiencing severe pain in the liver area and developed a fever.An abscess had formed in the necrotic tissue in segment iv, therefore treatment with wide-spectrum antibiotics was started.Attempts to percutaneously drain the abscess were unsuccessful due to rigidity of the surrounding fibrous tissue and surgical drainage was necessary.In the following weeks, the symptoms improved, only to return 3 days after ceasing antibiotic therapy.Once again, an abscess was found in segment iv, this time the patient underwent a left hepatectomy including the abscess and necrotic tissue.The patient made a full recovery and remains alive to the date of writing this essay.This case illustrates the essence of 90y-pet/ct to assess whether the treatment was performed as planned.Subtle changes in flow or catheter position may lead to a completely different distribution.Additionbal information received from author: 03-dec-2019.Batch number: 1699004.Treatment date: (b)(6) 2016.Perfused volume: right lobe.Desired dose: 110gy.Ordered activity 9000mbq.Prescribed activity: 3500mbq.Activity infused 3250mbq.Dose received: 2933mbq.Perfused volume: left lobe.Desired dose: 150gy.Ordered activity: 3000mbq.Prescribed activity:1090mbq.Activity infused: 1034mgq.Dose received: 1016mbq.

Manufacturer Narrative

Device history records were reviewed 17-feb-2020.Batch 1699004: a.No deviations were reported.B.Endotoxin testing results were <0.006 eu/mg; the limit is

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES, PRODUCT CODE: NAW
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 9346062
• MDR Text Key: 167562431
• Report Number: 3002124543-2019-00064
• Device Sequence Number: 1
• Product Code: NAW
• UDI-Device Identifier: 05060116920345
• UDI-Public: 05060116920345
• Combination Product (y/n): N
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: 1699004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR