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

Model Number BG3502-5-G

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

Patient Problem Unspecified Infection (1930)

Event Date 02/24/2017

Event Type  Injury  

Event Description

Two (2) cases carotid surgery.Bioglue used at carotid anastomoses.Both patients got infections at carotid area.This report represents the first of the two patients.Patient revision in operating room (o.R) today.(b)(4).Notes via doctor: "male, (b)(6), operation (b)(6) 2017 (longitudinal tea with bovine pericardium patch for asymptomatic stenosis) admission with putride secretion from lower wound edge (b)(6) 2017 (leucocytes 11.0, crp 0,1) first culture showed propionibacterium surgical exploration: (b)(6) 2017, debridement, vaculta with disinfectant rinsing solution.Grains of bioglue in wound, (pathological result: blood, fibrin, neurtophile granulocytes, lymphocytes plasmacells as well as ¿mehrkernige fremdkörper-riesenzellen¿) all intraoperative cultures negative.".

Manufacturer Narrative

Two cases carotid surgery.Bioglue used at carotid anastomoses.Both patients got infections at carotid area.This report represents the first of the two patients.Patient revision or today.Bg3502-5-g.Notes via doctor: "male, (b)(6), operation (b)(6) 2017 (longitudinal tea with bovine pericardium patch for asymptomatic stenosis) admission with putride secretion from lower wound edge (b)(6) 2017 (leucocytes 11.0, crp 0,1) first culture showed propionibacterium.Surgical exploration: (b)(6) 2017, debridement, vaculta with disinfectant rinsing solution.Grains of bioglue in wound, (pathological result: blood, fibrin, neurtophile granulocytes, lymphocytes plasmacells as well as ¿mehrkernige fremdkörper-riesenzellen¿) all intraoperative cultures negative.Multiple requests were made for the specific lot number used; however, all attempts were unsuccessful.A query of shipping records for the six months prior to the implant date did not return any lot numbers.Therefore, a review of manufacturing records was not performed.There was a review of the available information.On (b)(6) 2017 a (b)(6) male underwent a longitudinal tea (thrombo endarterectomy) with bovine pericardium patch for asymptomatic stenosis; bioglue was used at the carotid anastomoses.All intraoperative cultures negative.The patient was readmitted on (b)(6) 2017 with putrid secretion from lower wound edge, leucocytes 11.0 crp 0.1.The first culture showed propionibacterium.(b)(6) 2017 the surgeon performed surgical exploration including debridement, vaculta with disinfectant rinsing solution.Grains of bioglue were found in the wound.Pathological results showed blood, fibrin, neutrophils, lymphocytes, plasma cells as well as foreign body type multinuclear giant cells.Doctor stated, ¿in my opinion this is not a problem of bacterial infection but some kind of ¿foreign body rejection¿ or whatever you want to name it.¿ foreign body reactions have been reported in the literature with the use of bioglue.Coselli et al.Found 2.6% of bioglue patients developed inflammatory, immune systemic allergic reaction (coselli 2003).The histologic findings are consistent with the expected foreign body type inflammatory response that has been previously observed with the use of bioglue.The instructions for use list inflammatory and immune response as possible adverse incidents.Propionibacterium sp is a common commensal organism found on the skin and is rarely associated with infection.The reported laboratory results of total leucocyte count of 11.0k and crp 0.1 are not suggestive of a systemic infection.Furthermore, because bioglue undergoes a validated terminal sterilization process it is unlikely an infection would be related to the product.The reported event is consistent with a foreign body inflammatory response to bioglue.Such responses are not unexpected and adequate precautions and warnings are provided in the instructions for use (ifu).The instructions for use (ifu) state: ¿bioglue is not for patients with known sensitivity to materials of bovine origin.¿ "exercise caution with repeat exposure of bioglue in the same patient.Hypersensitivity reactions are possible upon exposure to bioglue.Sensitization has been observed in animals.¿.

Event Description

Two cases carotid surgery.Bioglue used at carotid anastomoses.Both patients got infections at carotid area.This report represents the first of the two patients.Patient revision or today.Bg3502-5-g.Notes via doctor: "male, (b)(6), operation (b)(6) 2017 (longitudinal tea with bovine pericardium patch for asymptomatic stenosis) admission with putride secretion from lower wound edge (b)(6) 2017 (leucocytes 11.0, crp 0,1) first culture showed propionibacterium.Surgical exploration: (b)(6) 2017, debridement, vaculta with disinfectant rinsing solution.Grains of bioglue in wound, (pathological result: blood, fibrin, neurtophile granulocytes, lymphocytes plasmacells as well as ¿mehrkernige fremdkörper-riesenzellen¿) all intraoperative cultures negative.

• 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: 6400298
• MDR Text Key: 69808222
• Report Number: 1063481-2017-00012
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: BG3502-5-G
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/24/2017
• Date Manufacturer Received: 02/24/2017
• 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): Other
• Patient Age: 32 YR