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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arrhythmia (1721); No Code Available (3191)

Event Type  Injury  

Event Description

According to the publication "intractable ventricular fibrillation - post ascending aortic dissection repair" in cardiovascular revascularization medicine, a case is described where bioglue embolized down the left main stem and resulted in refractory ventricular arrhythmia and hemodynamic instability.

Manufacturer Narrative

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

Manufacturer Narrative

According to the publication "intractable ventricular fibrillation - post ascending aortic dissection repair" in cardiovascular revascularization medicine, a case is described where bioglue embolized down the left main stem and resulted in refractory ventricular arrhythmia and hemodynamic instability.Multiple attempts were made to contact the corresponding author for additional information.The only additional information that was received stated "patient underwent aortic dissection repair and was brought back with refractory ventricular fibrillation (vf), when we found this space occupying pathology in the coronary, difficult to aspirate, clear edges and looked very likely to be glue.We wanted to aspirate the sample, so that we can send it off for pathology exam, but with every attempt, it went further down.Patient kept on having further vf episodes, so we decided to go ahead with stenting to restore blood flow.I have read the procedure in the patient's clinical charts that mentioned 'bioglue was applied with two interposition grafts." a date of the procedure could not be determined and a review of possible lots could not be performed.A review was performed of the available information.With the information available at the time of this report, a cause of the embolism observed in the patient as described in the publication could not be definitively determined.It is unclear in the publication how bioglue was specifically applied in this patient.According to the article, a patient experienced refractory ventricular arrythmia approximately 36 hours following aortic dissection repair in which bioglue was used on two interpositional grafts.It is possible that bioglue was applied only within the false lumen(s) to obliterate the false lumen(s), only on that anastomoses, or both.It is also unclear who performed the primary procedure and requests for operative notes have been unsuccessful.Although the embolic material was not definitively determined to be bioglue, additional information from the interventional cardiologist describes the embolic material as a "space occupying pathology in the coronary" that was "difficult to aspirate" with "clear edges" and "looked very likely to be glue." as such, while the identity of the embolic material cannot be definitively identified, the possibility that it was bioglue cannot be ruled out.Bioglue embolization has been previously reported when bioglue is applied to a suture line while the lumen is under negative pressure, such as use of a left ventricular vent.Entry into the coronary artery through a dissection re-entry point is another possible mechanism of embolization.Adequate precaution and warning against use of bioglue with a ventricular vent and protecting the vessel from possible re-entry sites is included in the instructions for use.

Event Description

According to the publication "intractable ventricular fibrillation - post ascending aortic dissection repair" in cardiovascular revascularization medicine, a case is described where bioglue embolized down the left main stem and resulted in refractory ventricular arrhythmia and hemodynamic instability.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: SURGICAL ADHESIVE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 3869280
• MDR Text Key: 4511831
• Report Number: 1063481-2014-00024
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR