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

Model Number BG UNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Pseudoaneurysm (2605)

Event Type  Injury  

Event Description

According to the publication titled: a word of caution: spontaneous rupture of the noncoronary sinus of the freestyle xenograft: two cases and review of the literature by gunga, z.Et al, a 72-year-old female patient with a history of aortic valve replacement in 2018 was admitted emergently for type a dissection in february 2020.Arr [aortic root replacement] using a 25-mm freestyle xenograft was performed, associated with hemiarch replacement.In november 2020, the patient was reoperated for severe tricuspid insufficiency, and operative findings pinpointed a small pseudoaneurysm on the suture line between the distal portion of the freestyle xenograft and the dacron prosthesis.This 2-mm orifice was sutured and strengthened with heterologous pericardium and bioglue.In october 2021, an acute thoracic pain triggered a computed tomography scan that showed a large circulating pseudoaneurysm of the aortic root originating from a tear in the ncs [noncoronary sinus] of the freestyle xenograft.Intraoperative findings confirmed the rupture in the central part of the ncs, without sign of infection.A redo arr using a 25-mm freestyle was performed.The patient had an uneventful recovery.Additional information has been requested.

Event Description

According to the publication titled: a word of caution: spontaneous rupture of the noncoronary sinus of the freestyle xenograft: two cases and review of the literature by gunga, z.Et al, a 72-year-old female patient with a history of aortic valve replacement in 2018 was admitted emergently for type a dissection in february 2020.Arr [aortic root replacement] using a 25-mm freestyle xenograft was performed, associated with hemiarch replacement.In november 2020, the patient was reoperated for severe tricuspid insufficiency, and operative findings pinpointed a small pseudoaneurysm on the suture line between the distal portion of the freestyle xenograft and the dacron prosthesis.This 2-mm orifice was sutured and strengthened with heterologous pericardium and bioglue.In october 2021, an acute thoracic pain triggered a computed tomography scan that showed a large circulating pseudoaneurysm of the aortic root originating from a tear in the ncs [noncoronary sinus] of the freestyle xenograft.Intraoperative findings confirmed the rupture in the central part of the ncs, without sign of infection.A redo arr using a 25-mm freestyle was performed.The patient had an uneventful recovery.No additional information forthcoming.

Manufacturer Narrative

The manufacturing records were not reviewed since the publication did not list a bioglue lot number or any dates of procedure.After further review of the article, 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, and the condition of the native tissue during the 2nd surgery when it was noted that bioglue was applied.The authors also state that there are several potential causes of the pseudoaneurysm: the specific vulnerabilities of the graft that was implanted, suggested weakness in the transitional zone between annular collagen fibers and the aortic elastic wall, traumatic manipulation of the graft, and finally the use of bioglue.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 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, 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) 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 pseudoaneurysms.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.Additionally, the authors also stated there are several potential causes of the pseudoaneurysm.The bioglue a/dfmea within rm-0001-01.009 was reviewed.The reported events are addressed in hazard step/item # a.1 22a and a.2 2a.No samples were returned, and lot number is unknown.There is insufficient information to determine if there is an association between the use of bioglue and the formation of pseudoaneurysms.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.Additionally, the authors also stated there are several potential causes of the pseudoaneurysm.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.No updates to the rmf are needed.The root cause of the reported event is unknown.However, 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.Additionally, the authors also stated there are several potential causes of the pseudoaneurysm.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 complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.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.B1 = adverse event e1 = initial reporter name and address.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): ARTIVION, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC. ¿ KENNESAW; 1655 roberts blvd nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15860640
• MDR Text Key: 304288855
• Report Number: 1063481-2022-00024
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2023

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 Model Number: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/01/2022
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/24/2022
• Supplement Dates Manufacturer Received: 11/01/2022
• Supplement Dates FDA Received: 01/28/2023
• 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): Required Intervention
• Patient Sex: Female