MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW BIOGLUE - CHINA STUDY; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5

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

Patient Problems Death (1802); Insufficient Information (4580)

Event Date 01/10/2018

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 initial report, patient (b)(6) received bioglue during the china trial and during the extension study had an sae.Additional information received relayed patient (b)(6) diagnosis was just listed as death, related to medical device is undetermined and related to surgery is undetermined.

Event Description

The fully translated serious adverse event form was provided.It states, "china extension study: subject zlb, screening no.03009, signed the informed consent on (b)(6), 2017 to participate 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 ", and was randomized to the bioglue group (b)(6) 2017, with the randomization no.Of (b)(6).On the same day, the subject received "ascending aortic arch replacement + descending aortic stent implantation" under general anesthesia.After the operation, the pseudolumen was closed by bioglue at the proximal end of the ascending aorta.Considering that the right coronary artery was involved before the operation, and it was difficult to stop cardiopulmonary bypass after the operation, ctnt was 1.3ng/ml, and the right heart was injured due to acute ischemia, the ecmo was implanted and returned to the intensive care unit for observation.On (b)(6) 2017, the investigator had repeatedly explained the subject's condition to the subject's family members, and the prognosis was extremely poor.The family members expressed their understanding and transferred back to the local hospital for treatment.At the same time, the subject completed the china trial.On august 26, 2020, the investigator contacted the subject by telephone for many times, but the telephone was not answered.On october 18, 2020, the investigator contacted the subjects again and successfully contacted his family member.When asked whether the family members of the subject agreed to participate in the ¿ china extension study¿, the investigator learned that the subject had died in 2018, and the family members did not want to disclose the specific time and cause of his death.This situation is now reported.".

• Brand Name: BIOGLUE - CHINA STUDY
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 11307205
• MDR Text Key: 231140763
• Report Number: 1063481-2021-00006
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG3510-5
• Device Lot Number: 17MGX003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death