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

Model Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Death (1802); Embolism (1829)

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the publication hickey, t.B.M., et al.¿iatrogenic embolization following cardiac intervention: postmortem analysis of 110 cases*.¿ cardiovascular pathology 40 (2019): 12-18.A retrospective clinical pathologic autopsy analysis of 110 people that underwent endovascular procedures between 2010 and 2016 within 90 days of death and followed by hospital autopsy.Case of tissue embolism: "this case (no.5) involved a (b)(6) woman with a past history of st-segment elevation myocardial infarction, resultant third-degree heart block, permanent pacemaker insertion, and two drug-eluting stents for complete occlusion of the right coronary artery 5 years previously.Due to worsening heart failure, she underwent repair of a left ventricular aneurysm and aortic valve.During the surgery, the left brachiocephalic vein was injured by in situ pacemaker wires and was repaired intraoperatively.A left mca territory infarct was identified day 1 postoperatively.Concurrently, she developed right-sided weakness, and a head ct scan confirmed a recent left mca territory infarct involving the basal ganglia, insula, and left temporal lobe.At autopsy, the left mca contained a tissue embolus confirmed by micro-scopic analysis.The embolic tissue displayed focal granulomatous inflammation to foreign suture-like material that had two appearances: eosinophilic and pale to white.These were suggestive of two different types of sutures.Fragments of eosinophilic material consistent with bioglue surgical adhesive were also identified.Detailed examination of the heart showed a left ventricle aneurysm repair site mural thrombus admixed with bioglue and suture material, the likely source of the left mca embolus." the patient died 15 days later following the endovascular procedure from the extensive left middle cerebral artery stroke.Cardiac tissue embolized to the left m1 mca artery.

Event Description

According to the publication hickey, t.B.M., et al.¿iatrogenic embolization following cardiac intervention: postmortem analysis of 110 cases*.¿ cardiovascular pathology 40 (2019): 12-18.A retrospective clinical pathologic autopsy analysis of 110 people that underwent endovascular procedures between 2010 and 2016 within 90 days of death and followed by hospital autopsy.Case of tissue embolism: "this case (no.5) involved a 75-year-old woman with a past history of st-segment elevation myocardial infarction, resultant third-degree heart block, permanent pacemaker insertion, and two drug-eluting stents for complete occlusion of the right coronary artery 5 years previously.Due to worsening heart failure, she underwent repair of a left ventricular aneurysm and aortic valve.During the surgery, the left brachiocephalic vein was injured by in situ pacemaker wires and was repaired intraoperatively.A left mca territory infarct was identified day 1 postoperatively.Concurrently, she developed right-sided weakness, and a head ct scan confirmed a recent left mca territory infarct involving the basal ganglia, insula, and left temporal lobe.At autopsy, the left mca contained a tissue embolus confirmed by micro-scopic analysis.The embolic tissue displayed focal granulomatous inflammation to foreign suture-like material that had two appearances: eosinophilic and pale to white.These were suggestive of two different types of sutures.Fragments of eosinophilic material consistent with bioglue surgical adhesive were also identified.Detailed examination of the heart showed a left ventricle aneurysm repair site mural thrombus admixed with bioglue and suture material, the likely source of the left mca embolus." the patient died 15 days later following the endovascular procedure from the extensive left middle cerebral artery stroke.Cardiac tissue embolized to the left m1 mca artery.

Manufacturer Narrative

Based on the information provided in the case report, fragments of bioglue admixed with suture material were found in the tissue embolus leading to the mca infarct.However, guidance for prevention of bioglue embolism during application is provided in the instructions for use (ifu).The risk file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and ifu.No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.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 SURGICAL ADHESIVE
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8451962
• MDR Text Key: 139850619
• Report Number: 1063481-2019-00013
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

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 Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/19/2019
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR