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

Model Number BG UNK

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Aneurysm (1708); Death (1802); No Code Available (3191); Solid Tumour (4552); Insufficient Information (4580)

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the publication kataoka t.Et al., ¿4 cases of aortic base re-dissociation after acute aortic dissection using bioglue,¿ "stump formation using bioglue performed during repair.4 hospital deaths (11.8%) and reoperation performed in 4 patients (13%).All 4 reoperation cases due to re-dissociation of uncrowned sinus.Case 1: 3 months after surgery pseudocele in the uncollected sinus with reoperation performed 4 months later.5 mm intimal crack in center of anastomosis of uncollected sinus showing re-dissociation which became aneurysm.Case 2: 3 months after surgery pseudocele in uncollected sinus and reoperation was performed 6 months later.Intimal crack of 5 mm in center of anastomosis of uncollected sinus with re-dissociation becoming an aneurysm.Case 3: after 9 months, pseudocele appeared in the uncrowded sinus becoming semi-urgent reoperation.5 mm intimal crack in center of anastomosis showing re-dissociation and became a tumor.Case 4: stump formation with bioglue and internal and external felt.After 1 year 6 months pseudocele showed in the uncrowded sinus.Reoperation performed 6 months after surgery which showed intimal crack of 5 mm in center of anastomosis of uncrowded sinus showing re-dissociation which became aneurysm.".

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. - KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd.; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 11386218
• MDR Text Key: 233790143
• Report Number: 1063481-2021-00010
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 01/30/2021; 01/30/2021
• Supplement Dates FDA Received: 04/12/2021; 04/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other