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

Model Number BG3510-5-J

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Regurgitation (1716)

Event Date 08/16/2020

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 cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the initial report, "the surgeon inserted ptfe felt which cut into sectorshape (2cm diameter) to false lumen between intima and adventitia and then applied bioglue to support them.Additionally, the band-shape felt was wrapped on both sides of intima and adventitia, ascending aorta replaced with vascular graft and finished surgery.It appeared that the patient developed severe ar by transesophageal echo and also found developing redissection that false lumen advanced to valsalva's sinus.Thus, re-operation was performed.".

Manufacturer Narrative

According to the initial report received: "the surgeon inserted ptfe felt which cut into sector-shape (2cm diameter) to false lumen between intima and adventitia and then applied bioglue to support them.However, false lumen advanced to valsalva's sinus after surgery, the patient developed severe ar [aortic regurgitation] and re-operation have been taken for bentall surgery.No more details is obtained so far.Sales rep has an appointment to visit the surgeon to hearing the details." additional information stated: "initial procedure on (b)(6) 2020: the surgeon inserted ptfe felt which cut into sectorshape (2cm diameter) to false lumen between intima and adventitia and then applied bioglue to support them.Additionally, the band-shape felt was wrapped on the both side of intima and adventitia, ascending aorta replaced to vascular graft (j graft) and finished surgery.(b)(6) 2020: it appeared that the patient developed severe ar by transesophageal echo and also found developing redissection that false lumen advanced to valsalva's sinus.Thus, re-operation was scheduled." this complaint is in reference to (b)(4), lot 3301.The manufacturing records for (b)(4), lot 3301 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were found to be related to the complaint.Per the additional information received, the surgeon states that there was insufficient priming of the syringe, and bioglue was not used as an adjunct to sutures.The condition/integrity of the native tissue where bioglue was applied was considered ¿friable tissue¿.The instructions for use for the product indicates that bioglue is to be used as an adjunct to standard methods of repair.No sutures were used in this procedure, bioglue was applied to the false lumen to support ptfe felt.Furthermore, the surgeon stated that the syringe was not correctly primed before the use of bioglue.The ifu specifies that the syringe must be primed and de-aired to ensure the ¿bioglue solutions are properly mixed¿ the root cause of the reported events is due to the improper use of bioglue.Bioglue was not used as an adjunct to sutures, and per the surgeon the syringe was not properly primed before use.Furthermore, the condition of the native tissue could have been a contributing factor.The bioglue risk file was reviewed.The instructions for use under ifu l6312 were reviewed and are found to be adequate.The ifu warns the user of a possible patient injury as a result of improper use of bioglue.The instructions for use list aortic insufficiency as a potential adverse event associated with the use of bioglue.No new risks were identified during the course of the risk management departmental complaint investigation.No increase in occurrence has occurred.All risks identified have been mitigated as far as possible and residual risk is acceptable.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
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10511448
• MDR Text Key: 206301224
• Report Number: 1063481-2020-00019
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

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-J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other