MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD LC BEAD LUMI; HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE, PRODUCT CODE: KRD

Model Number	40 - 90 MICRON
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vomiting (2144)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lc bead lumi was reported to have been used in the treatment of this patient.Lc bead lumi is available in the usa and is intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (avms).Patient (b)(6) from (b)(6) trial (b)(6) experienced: hematemesis (b)(6) 2017 to (b)(6) 2017.Investigator reported: event occurred after m0 treatment and patient had advanced liver disease with numerous previous locoregional therapies (y90, tace x 2, percutaneous ethanol ablation, rfa).Patient also had m1 treatment months before on (b)(6) 2017 and followed by percutaneous ethanol ablation.The m0 treatment (beads loaded with doxorubicin with 30 min absorbing time) was (b)(6) 2017 and date of event was (b)(6) 2017 where the patient received variceal banding ((b)(6) 2017) and subsequent embolization ((b)(6) 2017) and was ultimately transplanted (b)(6) 2018.No follow up after transplant.Lc bead lumi loaded with doxorubicin is considered off-label use; however the equivalent product dc bead lumi loaded with doxorubicin is approved for use in europe.Vessel or lesion/tumour rupture and haemorrhage are anticipated events documented in the risk management documentation/ifu.Btg medical assessment: hematemesis was due to variceal rupture (complication of portal hypertension).Hematemesis due to variceal rupture after chemoembolization with lc bead lumi¿ (40, 90 m) loaded with doxorubicin (off label use), is an anticipated, serious and device related adverse event.Not related with doxorubicin.Previous treatment and presence of advanced liver disease may have favoured the occurence.Patient went on to receive a liver transplant, the device remained in the patient under the time of liver transplant.Device return not possible.No batch review was possible for this case as the batch number could not be ascertained.No product malfunction/deficiency has been identified.No corrective/preventative action has been identified.Follow-up information was requested, but has not been received to date.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 or Problem Description
Patient (b)(6) from (b)(6) trial (b)(6) experienced: hematemesis (b)(6) 2017 to (b)(6) 2017.Investigator reported: event occurred after m0 treatment and patient had advanced liver disease with numerous previous locoregional therapies (y90, tace x 2, percutaneous ethanol ablation, rfa).Patient also had m1 treatment months before on (b)(6) 2017 and followed by percutaneous ethanol ablation.The m0 treatment (beads loaded with doxorubicin with 30 min absorbing time) was (b)(6) 2017 and date of event was (b)(6) 2017 where the patient received variceal banding ((b)(6) 2017) and subsequent embolization ((b)(6) 2017) and was ultimately transplanted (b)(6) 2018.No follow up after transplant.
Event or Problem Description
Patient (b)(6) from (b)(6) trial (b)(4) experienced: hematemesis on (b)(6) 2017 to (b)(6) 2017.Investigator reported: event occurred after m0 treatment and patient had advanced liver disease with numerous previous locoregional therapies (y90, tace x 2, percutaneous ethanol ablation, rfa).Patient also had m1 treatment months before on on (b)(6) 2017 and followed by percutaneous ethanol ablation.The m0 treatment (beads loaded with doxorubicin with 30 min absorbing time) was (b)(6) 2017 and date of event was (b)(6) 2017 where the patient received variceal banding (b)(6) 2017)) and subsequent embolization (b)(6) 2017)) and was ultimately transplanted on (b)(6) 2018.No follow-up after transplant.Lc bead lumi loaded with doxorubicin is considered off-label use.Vessel or lesion/tumour rupture and haemorrhage are anticipated events documented in the risk management documentation/ifu.Additional information received: 15-may-2019.Confirmation received that this case was initially assessed by pi as possibly related, further discussion with the doctor the hematemesis is unrelated and is likely a product of the patients liver disease.
Additional Manufacturer Narrative
Additional information was received 15-may-2019 from the reporting institution as follows: "we did initially put possibly related but after further discussion with dr.(b)(6) the hematemesis is unrelated and is likely a product of the patients liver disease.".

• Brand Name: LC BEAD LUMI
• Common Device Name: HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE, PRODUCT CODE: KRD
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 8184355
• Report Number: 3002124543-2018-00055
• Device Sequence Number: 1459916
• Product Code: KRD
• UDI-Device Identifier: 05060116921229
• UDI-Public: 5060116921229
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 40 - 90 MICRON
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2018
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention