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

Model Number	BG3510-5-US
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
Patient's wife called on 09/14/2017 to state her husband had branch arch replacement surgery on (b)(6) 2017.Suffered from a stroke on (b)(6) 2017, a thrombectomy was performed by neurosurgeon [doctor] to remove the clot.The material that was removed from the brain appeared to be foreign.According to the wife a pathology report was done on the foreign material which was alleged to be bioglue.The current status of the patient is hospitalized with ventilation.The patient was transferred from cardiac icu on hemicraniectomy watch, moved to neuro icu and is now back in cardiac icu.The patient had a high risk total arch replacement for dissection.Per the surgeon, bioglue was topically applied to each anastomosis according to the instructions for use.He woke up after surgery with right sided weakness.He was sent for neuro-intervention and a small piece of bioglue was allegedly retrieved from a branch of his mca.He has residual weakness.He will survive but with some neurologic deficit.
Additional Manufacturer Narrative
The following information was requested multiple times without success from the surgeon: operative notes, pathology report, picture of foreign material removed, amount of bioglue applied, specific information on location of application, information surrounding the preparation of bioglue, and patient comorbidities.The device history records for lot number 17mut002 was reviewed and it was confirmed that the record was controlled, available for review, and met all specifications per the device master record.No non-conformance's or deviations were associated with the event.  a review of the available information was performed.At this time not enough information has been supplied to cryolife to definitively determine if the foreign material removed was bioglue and if the foreign material is bioglue, to definitively determine how it entered the circulatory system.Bioglue embolization has been previously reported.Guidance related to prevention of bioglue embolism is provided in the product¿s instructions for use and include, but is not limited to, avoiding negative pressure during bioglue application to prevent bioglue from crossing through suture holes into the patient¿s cardiovascular system and protection of the true lumen during obliteration of the false lumen with bioglue in aortic dissection procedures.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.¿ root cause of the reported event is unknown.However, guidance for prevention of bioglue embolism during application is provided in the product¿s ifu.This event does not identify additional hazards or modify the probability and severity of existing hazards.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 or Problem Description
Patient's wife called on 09/14/2017 to state her husband had branch arch replacement surgery on (b)(6) 2017.Suffered from a stroke on (b)(6) 2017, a thrombectomy was performed by neurosurgeon [doctor] to remove the clot.The material that was removed from the brain appeared to be foreign.According to the wife a pathology report was done on the foreign material which was alleged to be bioglue.The current status of the patient is hospitalized with ventilation.The patient was transferred from cardiac icu on hemicraniectomy watch, moved to neuro icu and is now back in cardiac icu.The patient had a high risk total arch replacement for dissection.Per the surgeon, bioglue was topically applied to each anastomosis according to the instructions for use.He woke up after surgery with right sided weakness.He was sent for neuro-intervention and a small piece of bioglue was allegedly retrieved from a branch of his mca.He has residual weakness.He will survive but with some neurologic deficit.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Common Device Name: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 6928124
• Report Number: 1063481-2017-00035
• Device Sequence Number: 18858932
• Product Code: MUQ
• UDI-Device Identifier: 10877234000253
• UDI-Public: (01)10877234000253(17)190204(10)17MUT002
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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
• Operator of Device: Physician
• Device Expiration Date: 02/04/2019
• Device Model Number: BG3510-5-US
• Device Lot Number: 17MUT002
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/14/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Disability
• Patient Age: 63 YR