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

Model Number BG3510-5-G

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

Patient Problems Aneurysm (1708); Death (1802)

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.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 cryolife is accurate or has been confirmed by cryolife.

Event Description

Received notification that patient (b)(6) received bg during the (b)(6) trial and during the extension study had an (b)(6).Additional information received relayed that patient (b)(6) had a diagnosis of aortic dissection (type stanford a), high blood pressure; date of death is unknown; related to medical device is undetermined, and related to surgery is undetermined.

Event Description

Received notification that patient (b)(6) received bg during the china trial and during the extension study had an sae.Additional information received via email on 14-jan-2021 from m.S., cryolife clinical research, relayed that patient (b)(6) had a diagnosis of aortic dissection (type stanford a), high blood pressure; date of death is unknown; related to medical device is undetermined, and related to surgery is undetermined.Additional information received on 12-mar-2021 provided the following information from the translated sae report: subject zjp, screening no.03037, signed informed consent on (b)(6) 2018 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 ".On (b)(6) 2018, the subject was randomized to the bg group with the randomization number of 031.On the same day, the subject received "ascending aortic arch replacement + descending aortic stent" under general anesthesia intraoperative bioglue was used to close the false lumen in the proximal aorta.The operation was smooth and the subject returned to the icu safely.On (b)(6)2018, when the subject was discharged from the hospital, he did not respond to the call, and his temperature was 39.1.Sae was reported: septic shock, and the report date was (b)(6) 2018, which was unrelated to the study device.The family members asked to be discharged from the hospital automatically, and at the same time, the china trial was completed.On (b)(6) 2020, the investigator contacted the subject by telephone for many times, but did not contact the subject successfully.On (b)(6) 2020, the investigator contacted the subject again and got in touch with the subject's family members.When the family members of the subjects were asked whether the subject was agreed to participate in the project of the ¿ china extension study¿, it was known that the subject had been dead, but the family members did not want to disclose the information about the time and cause of subject death, the time of death is unknown.The correlation between the sae and the investigational device and the surgery were unknown.Treatment of serious adverse events: because the family members of the subject did not want to disclose the detailed information about the subject's death, the treatment of serious adverse events could not be known, and the subject's final outcome was death, and the correlation with the investigational device and the surgery in the original china study was unknown.No additional information forthcoming.

• Brand Name: BIOGLUE - CHINA STUDY
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 11237707
• MDR Text Key: 228924529
• Report Number: 1063481-2021-00003
• 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: 04/12/2021

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 Expiration Date: 03/20/2019
• Device Model Number: BG3510-5-G
• Device Lot Number: 17MGX003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death