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

Model Number BG3510-5-J

Device Problem Insufficient Information (3190)

Patient Problem Reaction to Medicinal Component of Device (4574)

Event Type  Injury  

Event Description

According to article, "a case of a coronary covered stent for repeated restenosis at the anastomosis site between saphenous vein graft and graft prosthesis" masaomi gohbara et al., "a (b)(6) man who had no past medical history suddenly felt back pain during a trip abroad and was diagnosed with urethral stone disease at the hospital.After 2 days of hospitalization, he returned to his country and was diagnosed with stanford type a acute aortic dissection on day 6.Emergent surgery [total arch replacement + aortic root replacement u graft 22 mm uapan life-line, tokyo, japan)] with a mechanical aortic valve [sjm regent 19mm (abbo.Tt, ca, usa)] and coronary artery reconstruction by a piehler method u graft 9 mm uapan life line, tokyo, japan)] was performed.His native right coronary artery (rca ) ostium and left main trunk (lmt) ostium were resected from his aortic root.Subsequently, his svg was used as a bypass graft from the j graft 9 mm uapan lifeline, tokyo, japan) to the posterior descending artery of the rca, and the distal end of j graft 9 mm uapan lifeline, tokyo, japan) was sutured to his lmt ostium (fig.1 ).Since it was difficult to control bleeding at the sutured anastomosis site between the svg and j graft 9 mm uapan lifeline, tokyo, japan), bioglue (cryo life, ga.Usa) surgical adhesive was used to control bleeding." "another mechanism was excessive inflammatory responses.Bioglue (cryolife, ga, usa) surgical adhesive, which has been widely used for vascular surgery, was used around the anastomosis site between the svg and j grafts uapan lifeline, tokyo, japan).Previous reports revealed that surgical sea lants, including bioglue (cryolife, ga, usa) surgical adhesive, had a side effect on inflammatory responses [5, 6].Bioglue (cryolife, ga, usa) surgical adhesive-induced inflammatory responses might cause vascular inflammation leading to excessive neointimal proliferation at the anastomosis site in the present case.".

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• 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: 12804774
• MDR Text Key: 282281864
• Report Number: 1063481-2021-00035
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/20/2021
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male