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

Model Number BG3510-5-J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Rupture (2208)

Event Type  Injury  

Event Description

According to the report, bioglue was used approximately one year ago (around (b)(6) 2013) in a "replacement ascending aorta surgery" procedure for type a acute ascending aorta dissection.Bioglue was applied to the proximal and distal suture lines and proximal and distal false lumen.The amount of bioglue applied per site is unknown.It is also unknown if other materials were used for reinforcement, if the target field was dry, if the vessel or graft was clamped and depressurized, and the condition of the native tissue is unknown.Bioglue was used as an adjunct to sutures, but the suturing technique is unknown.Bioglue was not used in a contaminated or infected area.A ct scan showed false aneurysm at the end of august."false aneurysm (rupture) was recognized distal of ascending aorta that bioglue was applied in initial procedure." the patient is under observation; re-procedure was not conducted because the patient has the patient's family does not wish for a re-procedure.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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

According to the report, bioglue was used approximately one year ago (around (b)(6) 2013) in a "replacement ascending aorta surgery" procedure for type a acute ascending aorta dissection.Bioglue was applied to the proximal and distal suture lines and proximal and distal false lumen.The amount of bioglue applied per site is unknown.It is also unknown if other materials were used for reinforcement, if the target field was dry, if the vessel or graft was clamped and depressurized, and the condition of the native tissue is unknown.Bioglue was used as an adjunct to sutures, but the suturing technique is unknown.Bioglue was not used in a contaminated or infected area.A ct scan showed false aneurysm at the end of (b)(6)."false aneurysm (rupture) was recognized distal of ascending aorta that bioglue was applied in initial procedure." the patient is under observation; re-procedure was not conducted because the patient has the patient's family does not wish for a re-procedure.No further information was available.Records were reviewed for possible lot numbers and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review was performed of the available information.Based on the information available at the time of this report, a cause of the "false aneurysm (rupture)" observed in the patient could not definitively be determined.The description of the event that actually occurred is unclear as survival from a rupture is not typical.Much information is unknown about the use of bioglue, including the amount of bioglue applied, the condition of the tissue/tissue integrity prior to bioglue application and following the observed event, whether or not the field was properly prepared prior to bioglue application, whether or not the syringe was properly prepared, whether or not the patient had underlying conditions that may have contributed to the event, the suturing technique used, or if other adjunctive measures/products were employed or used.A ct was performed, but the imaging has not been made available for review.Because a reoperation has not been performed, and likely will not be performed, no pathological examination has been conducted.The complainant states that the location of the "false aneurysm (rupture)" was "distal of ascending aorta that bioglue was applied in initial procedure." it is assumed that this is intended to mean that the false aneurysm was observed in the ascending aorta, distal to the location of the application of bioglue in the initial procedure.Based on this information, it is not likely that bioglue caused or contributed to the formation of the false aneurysm in this patient.

Event Description

According to the report, bioglue was used approximately one year ago (around (b)(6)2013) in a "replacement ascending aorta surgery" procedure for type a acute ascending aorta dissection.Bioglue was applied to the proximal and distal suture lines and proximal and distal false lumen.The amount of bioglue applied per site is unknown.It is also unknown if other materials were used for reinforcement, if the target field was dry, if the vessel or graft was clamped and depressurized, and the condition of the native tissue is unknown.Bioglue was used as an adjunct to sutures, but the suturing technique is unknown.Bioglue was not used in a contaminated or infected area.A ct scan showed false aneurysm at the end of (b)(6)."false aneurysm (rupture) was recognized distal of ascending aorta that bioglue was applied in initial procedure." the patient is under observation; re-procedure was not conducted because the patient has the patient's family does not wish for a re-procedure.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: SURGICAL ADHESIVE
• 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: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4131351
• MDR Text Key: 18873588
• Report Number: 1063481-2014-00042
• 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,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: BG3510-5-J
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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