MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5-J

Device Problem Migration (4003)

Patient Problem Foreign Body In Patient (2687)

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 journal article, ¿bioglue manifesting as a subaortic floating object seen during ventricular septal rupture surgery: a case report".(b)(6) man underwent ventricular septal rupture surgery, bioglue found floating in echocardiography.Removed during reoperation.

Manufacturer Narrative

Clinical/medical reviewed the available information.Per the article the patient underwent an urgent septal patch closure.Where bioglue was "sprayed into the space between the double patches, from the right ventricle to the left".A transesophageal echocardiography (tee) showed a subaortic floating object that was not seen preoperatively.The tee also showed an exacerbated mitral regurgitation, and the mitral valve was replaced.During this valve replacement operation, the object was removed and diagnosed as bioglue based on its appearance.The patient died of right heart failure on postoperative day 29, however, the authors do not attribute the patient's death to bioglue use.The article references the domestic (us) instructions for use (ifu) l6312.010, stating that "cryolife inc.Warns that the bioglue should not be applied within the intracardiac cavity because the glue is more likely to cause an embolism when applied to an intracardiac cavity than when used at extracardiac sites" warning in the ifu states, "do not allow bioglue in either the uncured or polymerized form to contact circulation blood.Bioglue entering the circulation can result in local or vascular obstruction." according to the journal article: sugimoto, k.Et al, "bioglue manifesting as a subaortic floating object seen during ventricular septal rupture surgery: a case report", 72-year-old man underwent ventricular septal rupture surgery.Bioglue was found floating in echocardiography and was removed during reoperation.The reported event occurred following the repair of an interventricular septal perforation.The use of bioglue for this application falls outside of the approved indications and therefore considered an off-label use.No further action recommended.Risk management reviewed the available information.The bioglue surgical adhesive a/dfmea within rm-0001-01.004 was reviewed.The reported event is addressed in hazard step/item #s 63, 65, 67, and 69.The bioglue surgical adhesive pfmea within rm-0001-02.004 was reviewed.The instructions for use under ifu l6312, rev 010 were reviewed and are found to be adequate.The ifu warns the user against applying bioglue within the intracardiac cavity because the glue is more likely to cause an embolism when applied to an intracardiac cavity than when used at extracardiac sites.Additionally, the ifu also warns the user not to allow ¿bioglue in either the uncured or polymerized form to contact circulation blood.Bioglue entering the circulation can result in local or vascular obstruction.¿ no increase in occurrence has occurred.No new risks were identified during the course of the risk management departmental complaint investigation.All risks identified have been mitigated as far as possible, and residual risk is acceptable.No further action is required.The root cause of this event is off-label use.There is no indication that an error or deficiency occurred at cryolife and 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 SYRINGE 5-PACK, 10 ML, JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10374018
• MDR Text Key: 201890642
• Report Number: 1063481-2020-00008
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 09/14/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other