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

Model Number BG3510-5-J

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

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 is accurate or has been confirmed by artivion.

Event Description

According to the initial report, bioglue was used at the distal end and the proximal end of the suture line.Five years later, the false aneurysm was found at the proximal anastomosis site and a bentall procedure was performed.

Manufacturer Narrative

The manufacturing records were not reviewed as artivion was unable to obtain the bioglue lot number or the date of procedure.Bg was used at the distal end and the proximal end of the suture line.5 years later, the false aneurysm was found at the proximal anastomosis site.The bentall was performed.8 years later after the first surgery (3 years later after the bentall surgery), the false aneurysm was founded at the distal end, and the patient was hospitalized for an emergency.After 3 days from hospitalization, the patient received an emergency arch aortic surgery for bloody sputum.When the adhesions were peeled off, the false aneurysm ruptured.The surgeon found that one third tissue in the distal end collapsed.Aortic arch replacement was performed under pcps.The patient was discharged." per the information provided by [distributor], the patient presented with an acute type a aortic dissection and underwent surgical repair including ascending aortic artery replacement.As provided above, bioglue was used at both the distal and proximal suture lines.Two post-operative complications were subsequently reported.The initial event was a pseudoaneurysm (false aneurysm) found at the proximal anastomosis site five years after the initial procedure.The patient underwent a bentall procedure at this time.Three years after the bentall procedure, another pseudoaneurysm [reported under: 1063481-2023-00009] was reported at the distal end and the patient was hospitalized.Adhesions were noted during the repair procedure.When these were ¿peeled off¿, the pseudoaneurysm ruptured and subsequently the patient underwent aortic arch replacement.Per the information provided the patient was discharged from the hospital.According to [distributor], no additional information will be forthcoming.The following information was not provided and is unknown: the amount of bioglue applied, the condition of the native tissue, what procedure it was used for, or if any other products were used during the procedure.Explanted tissue was not available for pathological evaluation.Adhesions and anastomotic pseudoaneurysm are listed in the ifu as potential adverse events related to cardiac and vascular 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 determine if there is an association between the use of bioglue and the pseudoaneurysms formed in the procedure.Pseudoaneurysm formation is a known complication in standard surgical repair of aortic dissections.Adhesions and anastomotic pseudoaneurysm are listed in the ifu as potential adverse events related to cardiac and vascular procedures.The condition of the native aortic tissue at the time of initial surgery is unknown in these cases.Pre-existing conditions such as aortic medial necrosis or other intrinsic aortic disease may have contributed to further complications.Based on the limited information available, no conclusion can be made at this time.The reported events will continue to be monitored for trends.Risk has been reduced as low as possible and overall residual risk is acceptable.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

According to the initial report, bioglue was used at the distal end and the proximal end of the suture line.Five years later, the false aneurysm was found at the proximal anastomosis site and a bentall procedure was performed.

• 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: 16639660
• MDR Text Key: 312260516
• Report Number: 1063481-2023-00008
• 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: 05/31/2023

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: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 05/31/2023
• 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): Hospitalization; Required Intervention
• Patient Sex: Male