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

Model Number BG UNK

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

Patient Problem Inflammation (1932)

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 publication by miralem pasic titled: late wound healing problems after use of bioglue for apical hemostasis during transapical aortic valve implantation reported bioglue (cryolife inc, kennesaw, ga, usa), a bovine serum albumin-glutaraldehyde tissue sealant, was at times used to seal the myocardial holes of the polypropylene stitches at the apex of the heart during transapical aortic valve implantation (tavi).We describe three patients who developed late wound healing problems after tavi that were thought to be caused by bioglue.The surgical wound revision was performed on the 115th, 41st and 60th days, respectively, after original tavi procedures.At revision, a ¿foreign body¿ reaction surrounded by healthy well-vascularized tissue was found.All intraoperative cultures were sterile despite evidence of purulent-like material at the time of wound debridement.The wounds healed ¿per primam intentionem¿ and the patients¿ postoperative course was also completely uneventful.

Event Description

According to the publication by miralem pasic titled: late wound healing problems after use of bioglue for apical hemostasis during transapical aortic valve implantation reportedbioglue (cryolife inc, kennesaw, ga, usa), a bovine serum albumin-glutaraldehyde tissue sealant, was at times used to seal the myocardial holes of the polypropylene stitches at the apex of the heart during transapical aortic valve implantation (tavi).We describe three patients who developed late wound healing problems after tavi that were thought to be caused by bioglue.The surgical wound revision was performed on the 115th, 41st and 60th days, respectively, after original tavi procedures.At revision, a ¿foreign body¿ reaction surrounded by healthy well-vascularized tissue was found.All intraoperative cultures were sterile despite evidence of purulent-like material at the time of wound debridement.The wounds healed ¿per primam intentionem¿ and the patients¿ postoperative course was also completely uneventful.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10780136
• MDR Text Key: 214427637
• Report Number: 1063481-2020-00029
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

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: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other