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

Model Number BG3510-5-J

Device Problem Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

Event Type  Injury  

Event Description

According to the initial report received via email on 01-jul-2021 "i would like to report a new customer complaint." according to the report received via email on 04-jul-2021 the patient developed a false aneurysm during the post-operative period.Additional information received the patient had an ascending aortic replacement in (b)(6) 2020 due to acute aortic dissection stanford type a.It is unknown when the patient developed the false aneurysm during the post-operative period.The false aneurysm was observed in the area positioned distal to the suture line.The surgeon mentioned that there was a possibility that bioglue has flowed and became the false aneurysm.The bioglue was applied to the suture line, false lumen distal end and false lumen proximal end.The status of the patient to date is in the hospital.Felt was used for reinforcement.The only treatment known is re-operation performed at an unspecified date.Bioglue was still visible.It is unknown if the false aneurysm was a continuation of a previously repaired aneurysm.The amount of bioglue used is unknown as is the lot number.No bioglue will be returned for evaluation.The request for operative notes has been denied.No samples were sent to pathology for examination.The surgeon mentioned that there was a possibility that priming and de-airing were not enough.No additional information is forthcoming.

Event Description

According to the initial report received via email on 01-jul-2021 "i would like to report a new customer complaint." according to the report received via email on 04-jul-2021 the patient developed a false aneurysm during the post-operative period.Additional information received the patient had an ascending aortic replacement in (b)(6) 2020 due to acute aortic dissection stanford type a.It is unknown when the patient developed the false aneurysm during the post-operative period.The false aneurysm was observed in the area positioned distal to the suture line.The surgeon mentioned that there was a possibility that bioglue has flowed and became the false aneurysm.The bioglue was applied to the suture line, false lumen distal end and false lumen proximal end.The status of the patient to date is in the hospital.Felt was used for reinforcement.The only treatment known is re-operation performed at an unspecified date.Bioglue was still visible.It is unknown if the false aneurysm was a continuation of a previously repaired aneurysm.The amount of bioglue used is unknown as is the lot number.No bioglue will be returned for evaluation.The request for operative notes has been denied.No samples were sent to pathology for examination.The surgeon mentioned that there was a possibility that priming and de-airing were not enough.No additional information is forthcoming.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10ML, JAPAN
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 12253232
• MDR Text Key: 264501191
• Report Number: 1063481-2021-00023
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other