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

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

This sae (surgical intervention to repair the closure of the femoral artery and hospitalization for observation) was classified by the study investigator as definitely related to the procedure.The closure device is not manufactured by btg.Although the closure device was used during the arterial procedure, the root cause of this event is not the arterial procedure itself, the therasphere administration or the therasphere device.The event is a result of a malfunction of the closure device (non btg device).No additional information is expected.

Event Description

Subject (b)(6) is a (b)(6) male enrolled in the (b)(6) study.This subject was diagnosed with hcc in the left lobe (segment ii & iii) on (b)(6) 2018.Liver status: liver cirrhosis; etiology of underlying liver disease: non-alcoholic steatohepatitis and hemochromatosis.Protal vein tumor thrombosis was present with vp3 invasion (or tumor thrombus) of first order branches of the portal vein.No prior treatment was received.This subject was treated with therasphere on (b)(6) 2018 with 96.3 gbq total activity administered.At the completion of the procedure, the patient experienced a closure device complication.The patient was immediately transferred to surgery to repair the closure of femoral artery.The patient was then hospitalized for observation.This sae was classified by the study investigator as definitely related to the procedure and not related to the rasphere device.This sae resolved on (b)(6) 2018.The event is related to the closure device used at the completion of the arterial procedure.This patient was discontinued from the study by the sponsor on (b)(6) 2019.

• 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: 8370402
• MDR Text Key: 137157737
• Report Number: 3002124543-2019-00009
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2019
• 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
• Treatment: UNKNOWN CLOSURE DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR