MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE; GLUE, SURGICAL ADHESIVE

Model Number BG3510-5

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

Patient Problem Aneurysm (1708)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient participating in the ¿multi-center, randomized, controlled clinical trial of bioglue surgical adhesive as an adjunct for structural repair and hemostasis in chinese patients with acute type a aortic dissections¿ had a reoperation on (b)(6) 2018.The subject came to the hospital on (b)(6) 2018 suffering from cold and fever for 10 days, chest tightness and chest pain for 1 week prior to going to the hospital.Cta showed descending aortic dissection, and the situation was progressive compared with previous situation, and interventional treatment was performed after exclusion of contraindications.On (b)(6) 2018, the stent graft of descending aorta was implanted.After the operation, symptomatic treatment was given and the recovery was good.Post-operation the subject's general condition was fair, with normal body temperature, food and sleep reported as ok, no obvious chest pain, chest tightness, palpitation, respiratory sound of both lungs was clear, heart did not reach pathological murmur, blood routine examination and biochemistry were normal, color doppler ultrasound showed that valve opening and closing were normal, heart function was good.Patient was discharged (b)(6) 2018.".

Manufacturer Narrative

Additional information was received from the surgeon stating the second dissection progressed due to the state of the patient and the event was not related to the use of bioglue.Per medical device reporting for manufacturers - fda guidance for industry and food and drug administration staff, section 2.16 an mdr report is not required when "you have information that would enable a person who is qualified to make a medical judgment to reasonably conclude that your device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury, if it were to recur." the acting surgeon stating that this event was not related to the product.Out of an abundance of caution a review of the information was performed by cryolife's medical director, who agreed this event was not product related.Therefore, further investigation is not warranted.

• Brand Name: BIOGLUE
• Type of Device: GLUE, SURGICAL ADHESIVE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 11031517
• MDR Text Key: 222318346
• Report Number: 1063481-2020-00036
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P01003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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: BG3510-5
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/30/2020
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1