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

Model Number BG UNK

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem 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 the journal article: "delayed femoral embolism of biological glue following the repair of type a dissection", "a (b)(6) year old patient was referred with a diagnosis of acute left lower limb ischaemia.A month before, he had been treated successfully for acute type a aortic dissection.The false lumen had then been obliterated by bioglue (cryolife international, kennesaw, ga, usa) injection between the dissected layers.Under general anaesthesia, the common femoral artery was explored and foreign material extracted from the posterior wall of the artery (panel a).Supplementary thrombo-embolectomy with a fogarty catheter restored satisfactory distal arterial flow.Histopathological analysis confirmed that the embolic material extracted was indeed biological glue (panel b).".

Manufacturer Narrative

The manufacturing records could not be reviewed as a lot number nor a date of surgery was provided.Per the journal article, ¿delayed femoral embolism of biological glue following the repair of type a dissection¿, a 56-year-old patient was diagnosed with an acute left lower limb ischemia.A month before, the patient was treated for acute type a aortic dissection and bioglue was injected between the dissected layers.Foreign material was extracted from the posterior wall of the femoral artery.Distal arterial flow was restored by a thromboembolectomy procedure using a catheter.Histopathological analysis confirmed the extracted embolic material was biological glue.The following information about the reported event is unknown: if negative pressure was avoided during application and polymerization, if a balloon catheter was inserted into the true lumen, and if the false lumen was overfilled.A copy of the histopathology report was not provided to cryolife.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 (ifu) 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.Bioglue entering the circulation can result in local or vascular obstruction.¿ vessel obstruction is also listed in the ifu as a potential adverse event.Based on the information provided, bioglue likely entered the true lumen of the arterial system through a distal re-entry site and embolized to the femoral 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.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 Description

According to the journal article: "delayed femoral embolism of biological glue following the repair of type a dissection", "a 56 year old patient was referred with a diagnosis of acute left lower limb ischaemia.A month before, he had been treated successfully for acute type a aortic dissection.The false lumen had then been obliterated by bioglue (cryolife international, kennesaw, ga, usa) injection between the dissected layers.Under general anaesthesia, the common femoral artery was explored and foreign material extracted from the posterior wall of the artery (panel a).Supplementary thrombo-embolectomy with a fogarty catheter restored satisfactory distal arterial flow.Histopathological analysis confirmed that the embolic material extracted was indeed biological glue (panel b).".

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC..; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 8861145
• MDR Text Key: 153389639
• Report Number: 1063481-2019-00045
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

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: Health Professional
• Device Model Number: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/15/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 56 YR