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

Model Number BG3510-5-J

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

Patient Problem Insufficient Information (4580)

Event Date 04/16/2024

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 artivion is accurate or has been confirmed by artivion.

Event Description

According to the initial report on 04/22/2024 " after using the bioglue in the false lumen, a mass of glue was formed that was large enough to be visible from the adventitia.There was a risk of vascular wall damage, the false lumen was reopened and the mass was removed." additional information received 04/23/2024: surgeon name: name is unknown amount of bioglue applied per site: one syringe was used, but the exact amount is unknown.What was the gross condition of the area where bioglue was applied?: no abnormal findings.Additional information received 04/23/2024: the lot number were not be provided from the surgeon.The product is not returned.The patient is doing well after the surgery.

• Brand Name: BIOGLUE- UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): ARTIVION, INC.; 1655 roberts boulevard, nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC. ¿ KENNESAW; 1655 roberts boulevard nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 19192489
• MDR Text Key: 341158750
• Report Number: 1063481-2024-00008
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P01003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

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 Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2024
• Initial Date FDA Received: 04/26/2024
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other