MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; YTTRIUM-90 GLASS MICROSPHERES

Model Number UNKNOWN

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

Patient Problems Atrial Tachycardia (1731); Death (1802); Respiratory Distress (2045); Tachycardia (2095)

Event Date 04/20/2017

Event Type  Death  

Event Description

Patient died [death]; respiratory distress [respiratory distress]; tachycardia [tachycardia].Case description: information received on (b)(6) 2017: this spontaneous medical device report was received from a physician concerning (b)(6) male patient.The patient's medical history included neuroendocrine liver metastasis and left hepatectomy 20 years ago.The patient's concomitant medications were not provided.On (b)(6) 2017, the patient received 101 gy of therasphere (lot number and expiration date were not provided) to the right lobe of the liver for neuroendocrine liver metastasis.On (b)(6) 2017, two days after the administration of therasphere, the family decided on comfort care measures only when the patient developed respiratory distress and tachycardia.On the same day, the patient died from an unknown cause.The reporter did not provide an assessment of the severity, seriousness or causality of the events to the therasphere.The company assessed the events death and respiratory distress as serious and the event tachycardia as non-serious.(b)(4) will submit a supplemental report if additional information is received.Case comment: death was considered anticipated according to therasphere current reference safety information whereas respiratory distress and tachycardia were unanticipated.The company considered the causality of respiratory distress is probably the underlying medical condition.However there is not enough information to determine a cause for the respiratory distress.There is no alleged malfunction, deterioration in performance or device failure reported.Death is a known complication which is documented within the therasphere risk management files.In an abundance of caution due to lack of information, (b)(4) cannot determine the role the administration of therasphere had as a contributory factor in the patient's death.

Manufacturer Narrative

Clarification was received from the administering physician that the patient was declining significantly prior to therasphere administration and that the therasphere treatment was insisted upon by the patient and the family as a last resort.The tachycardia, respiratory distress and death is not related to therasphere and are considered to be related to the patient's disease state.It is possible that the therasphere contributed to the clinical deterioration because the patient was not able to compensate for the treatment's stress due to the patient's poor clinical status.There was no device malfunction reported.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 physician on 20 mar 2018.Refer to initial report for event description 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 physician via email on 20 mar 2018.A response from the administering physician was received that day stating that the therasphere treatment for this patient was a last resort attempt ("last ditch effort").The patient was declining significantly and it was hoped/insisted by the patient and his family that they try therasphere.The administering physician reported that he canceled a previously scheduled administration 2 weeks before as the patient came in looking so poorly.The therasphere administration occurred on (b)(6) 2017 and the physician reported that the patient unfortunately ended up doing poorly.As reported in the initial report, the patient developed tachycardia and respiratory distress 2 days after the administration, was put on comfort care and died on (b)(6) 2017.

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback ; 300 four falls corp cntr - 380; 300 conshohocken st. rd.; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 6575029
• MDR Text Key: 75433499
• Report Number: 3002124543-2017-00022
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2018
• 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 Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 67 YR