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 Problems No Known Impact Or Consequence To Patient (2692); Vascular Dissection (3160)

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 report, a patient underwent an ascending aorta replacement for type a acute arch aorta dissection on (b)(6) 2016.Bioglue was applied to the proximal false lumen as well as proximal suture line, and the amount of bioglue was an "adequate amount (thickness: 1-2 mm, depth: <2 cm)." felt was used to shape the cut end of aorta.According to the distributor, "during the ascending aorta replacement before declamping, surgeon admitted the adventitia where bg [bioglue] was applied somewhat turned a little crisp and then tore.The situation required to turn on the heart-lung machine once again.Surgeon chose to use equine pericardium both the inside and the outside in order to anastomosis for reinforcement." surgeon's comment: "reported event might be attributed to the use of bg." patient information: "female, (b)(6).".

Manufacturer Narrative

The following additional information was received 04/11/2017 and 04/12/2017: no information available for this patient's co-morbidity and underlying conditions. clarification was requested as to the description of the "crisp" adventitia. the distributor replied "'crisp,' according to our sales rep, is probably a thin bg layer being friable."  it was asked whether the surgeon was manipulating the tissue in any way and with any mechanical instrument when it tore, and the distributor replied "we suppose surgeon was either manipulating the tissue or using any mechanical instrument, but we could not confirm it in details."  the exact lot number used for the case is unknown. possible lot numbers shipped to the hospital in the six months prior to implant are 15mjx021, 15mjx022, and 16mjx008. all three lots will be investigated.  this investigation is currently ongoing.  any additional information will be provided in the follow-up report.

Event Description

According to the report, a patient underwent an ascending aorta replacement for type "a" acute arch aorta dissection on (b)(4) 2016.Bioglue was applied to the proximal false lumen as well as proximal suture line, and the amount of bioglue was an "adequate amount (thickness: 1-2mm, depth: <2cm)." felt was used to shape the cut end of aorta.According to the distributor, "during the ascending aorta replacement before declamping, surgeon admitted the adventitia where bg [bioglue] was applied somewhat turned a little crisp and then tore.The situation required to turn on the heart-lung machine once again.Surgeon chose to use equine pericardium both the inside and the outside in order to anastomosis for reinforcement." surgeon's comment: "reported event might be attributed to the use of bg." patient information: "female, age (b)(6).".

Manufacturer Narrative

A review of the available information was performed.Based on the information, we were unable to determine a cause of the adventitia becoming "a little crisp" and tearing.Tearing of the tissue suggests poor quality of the native tissue and is unlikely related to the use of bioglue.The state of the native tissue integrity is unknown.The patient's comorbidities and underlying conditions are unknown.The root cause of the reported event is unknown.A definitive lot number was not provided.The records for lot numbers 15mjx021, 15mjx022, and 16mjx008, which were shipped to the hospital within six months of the bioglue implantation, were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master records.No non-conformance's or deviations were associated with the event.No further action warranted.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.

Event Description

According to the report, a patient underwent an ascending aorta replacement for type a acute arch aorta dissection on (b)(6) 2016.Bioglue was applied to the proximal false lumen as well as proximal suture line, and the amount of bioglue was an "adequate amount (thickness: 1-2mm, depth: <2cm)." felt was used to shape the cut end of aorta.According to the distributor, "during the ascending aorta replacement before declamping, surgeon admitted the adventitia where bg [bioglue] was applied somewhat turned a little crisp and then tore.The situation required to turn on the heart-lung machine once again.Surgeon chose to use equine pericardium both the inside and the outside in order to anastomosis for reinforcement." surgeon's comment: "reported event might be attributed to the use of bg." patient information: "female, age (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
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144
• MDR Report Key: 6463290
• MDR Text Key: 71888155
• Report Number: 1063481-2017-00017
• 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: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/22/2017
• Date Manufacturer Received: 03/22/2017
• 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; Other
• Patient Age: 76 YR