MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SYRINGE 5-PACK, 5ML, US; GLUE,SURGICAL,ARTERIES

Model Number BG3515-5-US

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Valve Stenosis (2024)

Event Date 09/06/2019

Event Type  Injury  

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, a sgpv00 was implanted on (b)(6) 2017.Following a transthoracic exercise stress echocardiogram on (b)(6) 2019, the patient was referred back to the surgeon due to pulmonic stenosis consistent with severe stenosis.A reoperation is scheduled for the near future.Op notes from the 2017 surgery were forwarded, and it was revealed that bioglue was used to support the anastomoses of the sgpv00 during the 2017 procedure.This report is relegated to the bioglue product.Reference 1063481-2019-00054 for information on the sgpv00.

Manufacturer Narrative

The manufacturing records were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.A review of the available information was performed.A patient underwent a ross procedure in 1999 and was diagnosed with pulmonic stenosis and aortic regurgitation in 2017.Per the operative report, the pulmonary homograft that was previously used was destroyed and there was substantial calcium and in the aorta.The surgeon replaced the patient¿s pulmonary valve with a cryolife sgpv00 and replaced the aortic valve with a bioprosthetic valve.The ascending aorta was replaced with a 30mm synthetic graft.Bioglue was used for both valve replacements and the patch placement as an adjunct to sutures at the anastomoses.On (b)(6) 2019 after stress echocardiogram testing, the patient¿s cardiologist referred the patient back to the surgeon for "pulmonic stenosis consistent with severe stenosis¿.The surgeon uses bioglue during almost every procedure and typically uses one 5ml syringe.As of this report, the explant surgery has yet to be scheduled.Per the information provided in the case report, the pulmonic stenosis is likely to have been caused by a problem or complication with the sgpv00.There is insufficient information to determine if there is an association between the use of bioglue and the reported pulmonic stenosis.All risks identified have been mitigated as far as possible and residual risk is acceptable.The ifu provides instruction on the safe use of the device.Reference 1063481-2019-00054 and 1063481-2019-00057 for related reported event.No further action recommended.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.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 5ML, US
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 9168320
• MDR Text Key: 161927651
• Report Number: 1063481-2019-00055
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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: 09/06/2018
• Device Model Number: BG3515-5-US
• Device Catalogue Number: BG3515-5-US
• Device Lot Number: 17MUV007
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/13/2019
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 09/13/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR