MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5-J

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

Patient Problems Anaphylactic Shock (1703); Infarction, Cerebral (1771); Loss of Vision (2139)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report, "on (b)(6) 2018 first surgery): total arch replacement + mvp bioglue was applied to proximal and distal suture line.On (b)(6) 2019 (second surgery): descending aorta replacement as originally planned bioglue was applied to proximal suture line as a repeated use to the single patient.After aortic cross-clamp removal, both face and hand of the patient turned red and swollen in 3 min.Blood pressure did not rise (30mmhg) and the surgeon confirmed anaphylactic shock.Blocked, adrenaline, and steroid were administered.Patient was back at extracorporeal circulation and in 40 mins, cutaneous symptoms seemed to have recovered, but not blood pressure.Pcps (percutaneous cardiopulmonary support was used and patient was sent to icu.Later patient developed cerebral infarction due to circulation management and resulted in blindness'.

Event Description

According to the initial report, "(b)(6) 2018 (first surgery): total arch replacement + mvp bioglue was applied to proximal and distal suture line.(b)(6) 2019 (second surgery): descending aorta replacement as originally planned bioglue was applied to proximal suture line as a repeated use to the single patient.After aortic cross-clamp removal, both face and hand of the patient turned red and swollen in 3 min.Blood pressure did not rise (30mmhg) and the surgeon confirmed anaphylactic shock.H2 blocked, adrenaline, and steroid were administered.Patient was back at extracoporeal circulation and in 40 mins, cutaneous symptoms seemed to have recovered, but not blood pressure.Pcps (percutaneous cardiopulmonar support was used and patient was sent to icu.Later patient developed cerebral infarction due to circulation management and resulted in blindness.".

Manufacturer Narrative

Exact lot number could not be confirmed.However two probable lot numbers were provided.The manufacturing records for all lots were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.The [initial information provided] states that felt was used as another material for reinforcement.It is unknown what other medications or products were used during the procedure.The [distributor] also, states that there were no noted patient allergies specifically to bovine materials and the ¿doctor was aware of the repeated use of bioglue being contradicted in the ifu, and attributed bioglue as one of the probable causes to the anaphylactic shock.¿ based on the information, insufficient evidence is provided to determine what caused the anaphylactic shock.However, a potential reaction to bioglue cannot be ruled out, for the described clinical symptoms are consistent with an anaphylactic shock response.The following is provided in the bioglue instructions for use (ifu): ¿exercise caution with repeat exposure of bioglue in the same patient.Hypersensitivity reactions are possible upon exposure to bioglue.Sensitizations have been observed in animals.¿ the ifu lists inflammatory, immune systemic allergic reaction as an observed adverse event that may occur with the use of bioglue.All risks identified have been mitigated as far as possible and residual risk is acceptable.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 8497400
• MDR Text Key: 141389043
• Report Number: 1063481-2019-00017
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

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
• Device Operator: Health Professional
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/11/2019
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other