MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE; SURGICAL GLUE ARTERIES

Model Number BG3510-5-J

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

Patient Problems Embolism (1829); Foreign Body Embolism (4439)

Event Date 01/12/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the publication by miyagi, t et al.Coronary artery embolism caused by bioglue surgical adhesive after type a acute aortic dissection repair, "we report a case of bioglue coronary artery embolism after type a acute aortic dissection repair confirmed using intravascular ultrasound imaging and pathological examination.It was successfully treated with percutaneous coronary intervention.¿ a 65-year-old woman underwent treatment for type a acute aortic dissection (taaad) where bioglue was used in the false lumen to reinforce the proximal and distal anastomotic sites.On postoperative day 12, the patient developed severe case of chest pain.¿cag showed subtotal occlusion of the mid-left anterior descending artery (lad) with a large filling defect that had a railroad track appearance and no atherosclerotic findings (figure 1a, video 1), which was suggestive of an embolic event.¿ cag of the right coronary artery showed total occlusion of the distal posterior descending artery (pda).Aspiration of yellow-brown material from pda confirmed to be bioglue fragment which also led to the conclusion that the mobile structure in mid-lad may also be bioglue emboli.

Event Description

According to the publication by miyagi, t et al., ¿coronary artery embolism caused by bioglue surgical adhesive after type a acute aortic dissection repair¿, a 65-year-old woman underwent treatment for type a acute aortic dissection (taaad) where bioglue was used in the false lumen to reinforce the proximal and distal anastomotic sites.On postoperative day 12, the patient developed severe case of chest pain.¿cag showed subtotal occlusion of the mid-left anterior descending artery (lad) with a large filling defect that had a railroad track appearance and no atherosclerotic findings (figure 1a, video 1), which was suggestive of an embolic event.¿ cag of the right coronary artery showed total occlusion of the distal posterior descending artery (pda).Aspiration of yellow-brown material from pda confirmed to be bioglue fragment which also led to the conclusion that the mobile structure in mid-lad may also be bioglue emboli.Per additional information by dr.Miyagi, the date of surgery to repair the taad was 1/1/17, and 5 to 10ml of bioglue was used in the operation.Either the applicator or spreader tip was used to apply the bioglue, which is normal practice for the surgeon.The bioglue was applied during circulatory arrest.Thus, the vessel was depressurized.Bioglue was allowed to polymerize for the full 2 minutes, and the area was dry when bioglue was applied.Bioglue was applied to the distal and proximal ends of the false lumen.The true lumen and other structures were protected using gauze.However, it is unknown if measures were taken to protect the coronary ostia and/or arteries.The date of intervention (pci) was (b)(6) 2017.Operative notes and notes from the intervention cannot be provided.The surgeon stated, "we have been applying bioglue in almost all patients undergoing type a acute aortic dissection repair even after this case happened because of its usefulness and low incidence of complications.However, due to the risk of embolism, we are still using it while maintaining proper use.".

• Brand Name: BIOGLUE
• Type of Device: SURGICAL GLUE ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 11259156
• MDR Text Key: 230447303
• Report Number: 1063481-2021-00004
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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: No Information
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR