MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE - UNKNOWN CONFIGURATION; GLUE,SURGICAL,ARTERIES

Model Number BG UNK

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

Patient Problem Bacterial Infection (1735)

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 journal article: bioglue: a nidus for late neck abscess after carotid endarterectomy, (b)(6) year old male patient presented with a left neck mass four years following carotid endarterectomy incorporating a bovine pericardial patch and bioglue.Surgical exploration found overlying the intact endarterectomy, containing pus (cultured staphylococcus aureus) and a black gelatinous material."histologically, this was a histiocytic reaction to eosinophilic material and is believed to represent persistent bioglue that became infected.Bioglue degrades by proteolysis, but multiple cases raise the prospect of its incomplete resorption and so becoming a nidus for infection.".

Event Description

According to the journal article: bioglue: a nidus for late neck abscess after carotid endarterectomy, 67 year old male patient presented with a left neck mass four years following carotid endarterectomy incorporating a bovine pericardial patch and bioglue.Surgical exploration found overlying the intact endarterectomy, containing pus (cultured staphylococcus aureus) and a black gelatinous material."histologically, this was a histiocytic reaction to eosinophilic material and is believed to represent persistent bioglue that became infected.Bioglue degrades by proteolysis, but multiple cases raise the prospect of its incomplete resorption and so becoming a nidus for infection.".

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 11100356
• MDR Text Key: 224785998
• Report Number: 1063481-2020-00037
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 03/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 67 YR