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

Model Number 7.0 GBQ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anaphylactic Shock (1703); Death (1802)

Event Date 03/21/2019

Event Type  Death  

Manufacturer Narrative

Btg medical assessment: unknown: patient, age, sex, type of disease, medical history, concomitant disease and medication.Complication during treatment procedure.Patient treated with therasphere, 2.48 gbq, on the morning and patient died the afternoon event: death.Causality: not possible to determine.Seriousness: yes.Severity: grade 5.Expectedness: yes.The reporter has not provided any causal link between the event and therasphere, therefore it is with an abundance of caution btg is reporting this event.No device malfunction was reported and no corrective and preventive action (capa) plan has been identified.A review of manufacturing records for batch number 1999124 was performed and summarised as follows: upon investigation of batch number 1999124, no issues were found with the batch.Per (b)(6): batch: 1999124; manufactured: 2019-03-14; calibration date: 2019-03-17; expiry date: 2019-03-29.Specific activity: 0.132gbq/mg.The autoclave cycle was acceptable as per (b)(4).The biological indicator was negative (no growth) at the end of the incubation period as per (b)(4).Lal assay for endotoxin result was (b)(4), which is below the specification limit of (b)(4).There was one planned deviation associated with this batch to temporarily disable the automatic pot lid lifter in cell 25.No effect on the quality of the final product.Package number (b)(4) was packaged for shipment to (b)(6) on (b)(6) 2019 for shipment on 2019-03-18.Vial (b)(4) (7.0gbq) was packaged.Vial (b)(4) had a dispensed mass of (b)(4) which is within the acceptable mass range of (b)(4).Vial (b)(4) met all acceptance criteria for the visual crimp inspection.Vial (b)(4) met the acceptance criteria for total activity (7.0gbq ± 10 %) with a measured total activity of 6.90gbq, per the calibration data sheet.There were no excursions associated with this batch for non-viable or viable environmental monitoring of the manufacturing facility.Trending of em data shows that the facility is in a state of control.This complaint has been classified as "unconfirmed'.No other information is available that could confirm/deny the alleged event.All reported events are anticipated as per the ifu/risk management documentation.At this time this report is considered final.

Event Description

Pso reported: patient treated this morning (b)(6) 2019 with therasphere had died in the afternoon.Date of therasphere treatment (b)(6) 2019.Dose vials ordered (gbq): 7.02 gbq.Dose prescribed (gy): 2.55 gbq.Activity infused (gbq): 2.48 gbq.On (b)(6) 2019 btg were contacted with regards to the radiation and time that should elapse prior to performing an autopsy.On 22-mar-2019 we received information stating that no determination of whether the patient's death was causally related to the therasphere implant, and until the autopsy proceeds (which is unlikely) or reach such a conclusion regarding a causal connection, then no further information will be provided.

Manufacturer Narrative

Btg medical assessment updated: no information available on patient tumour, clinical status before treatment, liver function before treatment that could explain the low platelet count (grade 3) when treatment was performed).And no explanation why the platelet administration was performed after angiography procedure not before on (b)(6) 2019 the patient presented for an out-patient therasphere procedure in interventional radiology (ir).Therasphere® administration was performed, and no complications were noted during procedure in the endoscopy recovery area.The patient's platelet count was noted to be 34,000 per microliter and 1 unit of apheresis platelets were initiated at approximately 12h30.At 12h45 the patient complained of pruritus, accompanied by urticaria, a burning ear sensation, and shortness of air.The patient then became hypotensive, bradycardic, hypoxic and then pulseless.The patient was resuscitated for approximately 35 minutes.Return of spontaneous circulation (rosc) was achieved and pulmonary icu was consulted for admission.On arrival by pulmonary icu team staff, the patient was intubated, placed on levophed / epinephrine drips, and initiated transcutaneous pacing.The patent was transferred to pacu for icu admission.In pacu while attempting central venous line placement, the patient's end tidal co2 plethysmography decreased, and the patient became pulseless again.Ultrasound was used for line placement and the patient was noticed to not have a pulse within the femoral artery.Cpr was again initiated, which continued for approximately 20 minutes, although rosc was not achieved.A subsequent bedside ultrasound revealed cardiac standstill.The patient's wife was notified by the pulmonary team that the patient expired.Plasma tryptase level was very high (>200 micg/l), which is consistent with an anaphylactic reaction.Batch record documents were reviewed, there was no device failure or malfunction.The event is not related to device or procedure administration, the event is related to platelet administration.

Event Description

Pso reported: patient treated this morning (b)(6) 2019 with therasphere had died in the afternoon.Date of therasphere treatment (b)(6) 2019.Dose vials ordered (gbq): 7.02 gbq.Dose prescribed (gy): 2.55 gbq.Activity infused (gbq): 2.48 gbq.On (b)(6) 2019 btg were contacted with regards to the radiation and time that should elapse prior to performing an autopsy.On (b)(6) 2019 we received information stating that no determination of whether the patient's death was causally related to the therasphere implant, and until the autopsy proceeds (which is unlikely) or reach such a conclusion regarding a causal connection, then no further information will be provided.Additional information received 06-may-2019: the patient was receiving platelets 1 hour after a therasphere procedure, and suffered an anaphylactic reaction that lead to the patient's death.The therasphere procedure was uneventful and nuclear imaging scan performed after (a safety check that is part of the protocol) showed no issue whatsoever from the radio-embolic particles.The patient began experiencing severe allergic type of symptoms 10 minutes after initiating platelet transfusion and went into cardiorespiratory arrest 5 minutes after.Platelet transfusions are not part of the therasphere protocol and would be given to any patient undergoing any ir procedure, if indicated for low platelets.The patient had no prior history of reaction to platelets, had received platelets before with no issues, and the platelets had been cross-checked by the blood bank prior to being given to the patient, so there would have been no indication that this reaction would happen.Physician stated: this reaction to the platelets was unrelated to the therasphere device.The physicians in blood bank conducted an investigation, and concluded with a high degree of medical certainty that the patient experienced a fatal anaphylactic reaction to the blood products, which could not have been screened for prior to the administration, and thus was unforeseen and unpreventable.The physicians in blood bank conducted an investigation and concluded with a high degree of medical certainty that the patient experienced a fatal anaphylactic reaction to the blood products, which could not have been screened for prior to the administration, and thus was unforeseen and unpreventable.Additional information received 09-may-2019: on (b)(6) 2019 the patient presented for an out-patient therasphere procedure in interventional radiology (ir).Therasphere® administration was performed, and no complications were noted during procedure in the endoscopy recovery area.The patient's platelet count was noted to be 34,000 per microliter and 1 unit of apheresis platelets were initiated at approximately 12h30.At 12h45 the patient complained of pruritus, accompanied by urticaria, a burning ear sensation, and shortness of breath.The patient then became hypotensive, bradycardic, hypoxic and then pulseless.The patient was resuscitated for approximately 35 minutes.Return of spontaneous circulation (rosc) was achieved and pulmonary icu was consulted for admission.On arrival by pulmonary icu team staff, the patient was intubated, placed on levophed / epinephrine drips, and initiated transcutaneous pacing.The patent was transferred to pacu for icu admission.In pacu while attempting central venous line placement, the patient's' end tidal co2 plethysmography decreased, and the patient became pulseless again.Ultrasound was used for line placement and the patient was noticed to not have a pulse within the femoral artery.Cpr was again initiated, which continued for approximately 20 minutes, although rosc was not achieved.A subsequent bedside ultrasound revealed cardiac standstill.The patient's' wife was notified by the pulmonary team that the patient expired.

• 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
• Manufacturer (Section G): BIOCOMPATIBLES UK; chapman house; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback-aballo ; 300 four falls corporate cente; 300 conshohocken state road; west conshohocken,, PA 19428-2998 ; 6103311537
• MDR Report Key: 8513222
• MDR Text Key: 141906060
• Report Number: 3002124543-2019-00036
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7.0 GBQ
• Device Catalogue Number: N/A
• Device Lot Number: 1999124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Death