MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; 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.

Event Description

According to the initial report, "doctor used bioglue and within 6 months from the date of use formation of false aneurysm was confirmed as a postoperative outcome on sites where bioglue was previously used.Doctor's comment: it is unknown whether bioglue is attributed to the formation of false aneurysm.Bioglue was applied to proximal false lumen.As postoperative outcome within 6 months from the date of use (unknown), formation of false aneurysm has been reported on sites where bioglue was previously used.Current patient status: unknown.".

Manufacturer Narrative

Based on additional information it appears bioglue was placed on "extremely fragile tissue." the application of bioglue to extremely fragile tissue does raise the question of whether attempted salvage of the native aorta was an appropriate surgical decision.Perhaps the native tissue was too damaged to be repaired and an aortic replacement with a synthetic graft should have been considered.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.

Manufacturer Narrative

A review of manufacturing records could not be performed as lot numbers are unknown.Additionally, a query could not be performed for potential lot numbers shipped to the hospital prior to implant as date of implant is unknown.A review of the available information was performed.An operation was performed for an acute type a aortic dissection, bioglue was applied to the proximal false lumen.Exact date of original surgery is unknown however the it is known that surgery occurred in 2017 between january and march.Within 6 months from the date of original surgery, exact time frame unknown, a false aneurysm was reported ¿where bioglue was previously used.¿ the patient underwent a re-operation.Doctor stated, ¿it is unknown whether bioglue is attributed to the formation of false aneurysm.¿ information surrounding the initial operation, pseudoaneurysm formation, and reoperation is unknown; in particular the following information: the time between the initial operation and the false aneurysm, where the false aneurysm is located, if bioglue was properly de-aired and primed, and amount of bioglue applied.Pseudoaneurysm formation is a known complication in standard surgical repair.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 (b)(6) 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) the root cause of the reported event is unknown however the surgeon did not attribute the pseudoaneurysm formation to bioglue.The ifu lists anastomotic pseudoaneurysm as a potential complication associated with the use of bioglue.

Event Description

According to the initial report, "doctor used bioglue and within 6 months from the date of use formation of false aneurysm was confirmed as a postoperative outcome on sites where bioglue was previously used.Doctor's comment: it is unknown whether bioglue is attributed to the formation of false aneurysm.Bioglue was applied to proximal false lumen.As postoperative outcome within 6 months from the date of use (unknown), formation of false aneurysm has been reported on sites where bioglue was previously used.Reportedly, hole was found in the patient's blood vessel walls and re-operation followed."according to the distributor, "specific date of first surgery is unknown, but it took place in year 2017, between (b)(6).".

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 7126504
• MDR Text Key: 95181211
• Report Number: 1063481-2017-00045
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/04/2017
• Date Manufacturer Received: 12/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other