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

Model Number BG UNK

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

Event Type  Injury  

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- formerly cryolife/jotec is accurate or has been confirmed by artivion.

Event Description

According to the initial report, a false aneurysm with unknown cause occurred following the use of bioglue.

Manufacturer Narrative

According to the initial report received, a false aneurysm with unknown cause occurred following the use of bioglue.Multiple attempts for additional information were unmet.A sample evaluation was not performed as no product was returned.Manufacturing records could not be reviewed as no lot numbers or dates of surgery were provided.The following information was not provided and is unknown: the amount of bioglue applied, the condition of the native tissue, or if any other products were used during these procedures.Per kitamura, et al.(2018), pseudoaneurysm formation ¿is not a rare late complication 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 the fragility of the dissected aortic wall at the anastomosis and from the chemical reaction due to the aldehyde contained in the glue material (bingley ja, et al.).¿ perhaps the native tissue was too damaged to be repaired and an aortic replacement with a synthetic graft should have been considered.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 operations in which bioglue was used.Postoperative pseudoaneurysm formation occurred in 3.3% of the patients (fehrenbacher 2006).Weiner, et al.Presented at the 15th world congress of heart disease in vancouver, canada in july 2010 they identified 97 consecutive patients in whom bioglue was used to reinforce thoracic aortic suture lines.During follow-up, 2 patients were identified as having a pseudoaneurysm.In the control group, without bioglue use, similar incidences of pseudoaneurysm formation was noted (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) there is insufficient information to draw definitive conclusions or associations with respect to the utilization of bioglue and pseudoaneurysm formation for the cases performed in this hospital.Pseudoaneurysm formation is a known complication in standard surgical repair of aortic dissections.The condition of the native aortic tissue at the time of initial surgery is unknown in these cases.Preexisting conditions such as aortic medial necrosis or other intrinsic aortic disease may have contributed to further complications.Based on the limited information available, and the uncertainty in regards to the alleged deficiency, no conclusion can be made at this time.The bioglue a/dfmea was reviewed.The reported events are addressed.The occurrence rating based on the previous 18-months did not increase.The reported events will continue to be monitored for trends.No updates to the rmf are needed in response to this complaint.Risk has been reduced as low as possible and overall residual risk is acceptable.Reference: fehrenbacher jw, et al.¿use of bioglue in aortic surgery: proper application techniques and results in 92 patients.¿ heart surg forum 2006; 9(5) 1-6 ma, et al.¿does bioglue contribute to anastomotic pseudoaneurysm after thoracic aortic surgery?¿ j thorac dis 2017; 9(8)2491-2497 weiner j, et al.¿bioglue does not predispose to anastomotic pseudoaneurysm in thoracic aortic surgery.¿ presented at international academy of cardiology 15th world congress on heart disease.(poster) 2010.Kitamura t, et al.¿repeat surgical intervention after aortic repair for acute stanford type a dissection.¿ general thoracic and cardiovascular surgery (2018) 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- formerly cryolife/jotec is accurate or has been confirmed by artivion.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• 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: 15715864
• MDR Text Key: 302864407
• Report Number: 1063481-2022-00023
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P01003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: BG UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: No
• 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