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 Problems Inflammation (1932); Pseudoaneurysm (2605); Aortic Valve Insufficiency/ Regurgitation (4450); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Between january 2000 and march 2019, 26 patients underwent reoperative valve-sparing aortic root reconstruction using the reimplantation technique.Given the study was retrospective and nonrandomized, the initial operations were performed in several institutions by different aortic surgeons.¿because not all patients were operated on initially in our institution, the proximal anastomoses were carried out by various techniques.Moreover, surgical glue use and stump plasty for reinforcement of proximal anastomosis were different in each case.¿ when bioglue was used in the initial operation ¿inflammatory changes and crystals of the residual glue were found in the tunica medica.In this patient series, bioglue induced partial lacerations in the tunica media, and a foreign-body reaction remained in 5 patients¿.The number of patients that developed a pseudoaneurysm was not given in the publication, they state: ¿our case suggested that the risk of pseudoaneurysm at the site of the proximal anastomosis even if bioglue was used¿.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 11371650
• MDR Text Key: 233254559
• Report Number: 1063481-2021-00009
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening