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

Model Number BG3510-5-J

Device Problem Material Separation (1562)

Patient Problems Pseudoaneurysm (2605); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

According to the initial report received regarding a bioglue patient, "1 month later after the first surgery, the re-surgery was undergone.The reason of the re-surgery is unknown yet, but it is not due to rupture.The adventitia which bg was used in was melted and bg was visible.Bg has become hard, but it was not adhered to the tissue and could be removed easily.The re-surgery was performed, and another adhesive was used in the false lumen.".

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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 artivion is accurate or has been confirmed by artivion.

Event Description

Indication for surgery aortic dissection.Date of procedure (b)(6) 2020.Anatomical site(s) where bioglue was applied: suture line, false lumen distal end, or false lumen proximal end? central false lumen.Amount of bioglue applied per site proper quantity.Was the target field dry at the time of application? yes.Did the patient develop any unexpected post-operative events thought to be related to the use of bioglue? if yes, please describe.The re-surgery was undergone due to false aneurysm in the aortic root.The adventitia which bg was used in was melted and bg was visible.Bg has become hard, but it was not adhered to the tissue and could be removed easily.Were samples sent to pathology for examination? no.What is the patient's current status? the patient is getting better.Is the surgeon a frequent user of bioglue? the surgeon has used more over 10 per a year from the beginning the release of bg.Were any preparation steps not in the ifu performed, such as heat in water bath, add antibiotics, sterilize syringe? no.

Manufacturer Narrative

The manufacturing records could not be reviewed as no lot numbers were provided and the exact surgery dates are unknown.The following information was not provided and is unknown: the amount of bioglue applied, whether the syringe was primed and de-aired per the ifu, if the target field was dry at the time of application, whether the bioglue was allowed to polymerize for a full 2 minutes, and the condition of the native tissue.Pseudoaneurysm formation has been reported in previous literature.Per kitamura et al, pseudoaneurysm formation ¿is not a rare late complication late after repair of acute aortic dissection (mohammadi, s et al).The underlying mechanism of pseudoaneurysm formation is considered to be associated with tissue cutting due to the fragility of the dissected aortic wall at the anastomosis and from the chemical reaction to the aldehyde contained in the glue material (bingley, ja et al).¿ furthermore, while surgical glue is helpful in surgery for acute type a aortic dissection, it may also cause late pseudoaneurysm formation or valve deterioration when not used properly (kitamura et al).Dr.Fehrenbacher et al.Performed a retrospective review of 92 consecutive patients who underwent complex operation in which bioglue was used.Postoperative pseudoaneurysm formation occurred in 3.3% of the patients (fehrenbacher 2006).Weiner et al.Presented at 15th world congress of heart disease in vancouver, canada in july 2010 they identified 97consecutive patients in whom bioglue was used to reinforce thoracic aortic suture lines.During follow-up, 2 patients were identified as having a pseudoaneurysm, the control group, without bioglue use, had similar incidences of pseudoaneurysm formation (weiner 2010).Ma et al.Reviewed 233 patients with a mean follow up time of 2.4 years post-operation; a pseudoaneurysm was detected in only 1 patient (0.6%).The authors concluded, ¿the use of bioglue in thoracic aortic surgery was not associated with excess incidence of anastomotic pseudoaneurysm formation following surgical repair of thoracic aortic disease.¿ (ma 2017).The bioglue risk management file was reviewed.The reported events are addressed.No samples were returned, and the lot number is unknown.Based on the available information provided in the case report, we are unable to definitively determine the cause of the events observed.There is insufficient information to determine if there is an association between the use of bioglue and the formation of pseudoanuerysms.Pseudoaneurysm formation is a known complication in standard surgical repair of aortic dissections.The condition of the native aortic tissue at the time of surgery is unknown in this case.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 artivion- formerly cryolife/jotec 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 artivion is accurate or has been confirmed by artivion.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): ARTIVION, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15962316
• MDR Text Key: 305330436
• Report Number: 1063481-2022-00026
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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: Lay User/Patient
• Device Model Number: BG3510-5-J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 02/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other