MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW BIOGLUE - UNKNOWN CONFIGURATION; GLUE,SURGICAL,ARTERIES

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Embolism (1829); Ischemia (1942)

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 article, "acute limb ischaemia due to embolisation of biological glue 45 days after surgery - m.El feghaly, e.Chahine, m.Abi ghanem, o.Abou zahr, m.Alayli, b.Abu khalil", abstract introduction - "since their introduction, biological glues have been more often used in cardiac and vascular surgery in order to control bleeding and reinforce surgical anastomotic sites." report: "we report a case of a (b)(6)-year-old woman diagnosed with acute limb ischaemia due to embolisation of biological glue, 45 days after her surgery for ascending aortic dissection.Her ischaemia was successfully relieved by an urgent thrombectomy." discussion: "complications due to the use of biological glues remain rare but are very serious.Preventive measures and intra-operative precautions must be considered in order to avoid most of these complications.".

Manufacturer Narrative

According to article, "acute limb ischaemia due to embolisation of biological glue 45 days after surgery - m.El feghaly, e.Chahine, m.Abi ghanem, o.Abou zahr, m.Alayli, b.Abu khalil", abstract - introduction - "since their introduction, biological glues have been more often used in cardiac and vascular surgery in order to control bleeding and reinforce surgical anastomotic sites." report: "we report a case of a 54-year-oldwomandiagnosed with acute limb ischaemia due to embolization of biological glue, 45 days after her surgery for ascending aortic dissection.Her ischaemia was successfully relieved by an urgent thrombectomy." discussion: "complications due to the use of biological glues remain rare but are very serious.Preventive measures and intra-operative precautions must be considered in order to avoid most of these complications." attempts for additional information have gone unmet.A review of manufacturing records could not be performed as a definitive lot number was not provided by the complainant.No product was returned.If information is provided in the future, a supplemental report will be issued.A review of the available information was performed.Per the article, this was an acute dissection of a large aneurysm with very thin tissue and the dissection involving the coronary arteries.Seven syringes of bioglue was used to reinforce the anastomotic sites during the procedure: three syringes used between the layers and four externally.Five weeks post operation an urgent ultrasound of the lower limb found complete occlusion of right common iliac artery.An artery thrombectomy was performed and bioglue fragments with sizes ranging from 2 to 12 mm were removed and sent to pathology.The authors concluded that the probable cause was bioglue traveling from the false lumen to the true one through distal re-entry sites.They also discuss precautions that need to be taken when using bioglue; applying bioglue to a dry field and placing gauze in the aortic lumen or a balloon catheter in the true lumen to prevent accidental bioglue insertion into the true lumen.They state, "complications due to the use of biological glues remain rare but are very serious.Preventive measures and intra-operative precautions must be considered in order to avoid most of these complications".Embolization of bioglue has been reported previously in literature (bernabeu 2005, furukawa 2015).However, guidance related to the prevention of bioglue embolism is provided in the instructions for use and include: 1.Avoiding negative pressure during bioglue application to prevent bioglue from crossing through the suture holes in the patient's cardiovascular system, and 2.Inserting a balloon catheter into the true lumen to define the distal terminus for the application of bioglue and prevent embolization through a distal re-entry point.Warning in the ifu states, "do not allow bioglue in either the uncured or polymerized form to contact circulation blood.Vessel obstruction is also listed in the lfu as a potential adverse event.Based on the information provided and the authors' conclusion, root cause for this event is bioglue likely entered the true lumen of the arteria l system through a distal re-entry site and embolized to the right common iliac artery.However, guidance for prevention of bioglue embolism during application is provided in the product's ifu.Additionally, "vessel obstruction" is listed as a potential complication.No further action is warranted at this time.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 - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10476481
• MDR Text Key: 205126482
• Report Number: 1063481-2020-00017
• 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: 10/15/2020

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/04/2020
• Initial Date Manufacturer Received: 08/04/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR