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

Model Number BG3510-5-J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/09/2015

Event Type  Injury  

Event Description

According to the report, on (b)(6) 2015, bioglue was used in a total arch aorta replacement surgery for a type-a acute ascending aorta dissection.It was applied to the proximal false lumen and the amount applied was "quantum libet" (dr's comment).Some packs were put in the aorta during bioglue application.The target field was dry at the time of application and bioglue was allowed to polymerize for a full two minutes.On (b)(6) 2015, the surgeon found a solid in the lad.

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, on (b)(6) 2015, bioglue was used in a total arch aorta replacement surgery for a type-a acute ascending aorta dissection.It was applied to the proximal false lumen and the amount applied was "quantum libet" (dr's comment).Some packs were put in the aorta during bioglue application.The target field was dry at the time of application and bioglue was allowed to polymerize for a full two minutes.On (b)(6) /2015, the surgeon found a solid in the lad.Additional information was received which indicated a part of solid was removed by ptca, but other material was not removed by ptca.The physician secured it to a vessel by a stent.The customer performed a pathological examination of it, and according to the results, a uniform basophilic pattern was confirmed."it looks like the artifact than a biological material.However, it was not identified.The patient already left the hospital without additional procedure." the manufacturing records for possible lots 14mjx021 and 14mjx023 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.A review was performed of the available information.According to the available information, there was an obstruction of the lad occurring 8 days after surgical repair of a type-a aortic dissection repair using bioglue.Solid material was removed during ptca and submitted to pathology for examination.Histology showed a uniform basophilic pattern suggestive of biologic material.The pathology findings are not consistent with bioglue as bioglue has a uniform eosinophilic appearance on histology.The nature of the material remains unknown.The root cause for the reported event is unknown.However, the pathology findings are not consistent with bioglue embolization.

Event Description

According to the report, on (b)(6) 2015, bioglue was used in a total arch aorta replacement surgery for a type-a acute ascending aorta dissection.It was applied to the proximal false lumen and the amount applied was "quantum libet" (dr's comment).Some packs were put in the aorta during bioglue application.The target field was dry at the time of application and bioglue was allowed to polymerize for a full two minutes.On (b)(6) 2015, the surgeon found a solid in the lad.

• 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: 4726100
• MDR Text Key: 5737401
• Report Number: 1063481-2015-00053
• 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,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• 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: 04/14/2015
• 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