MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC UNK LIQUID EMBOLIC; TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS

Catalog Number UNK LIQUID EMBOLIC

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

Patient Problems Intracranial Hemorrhage (1891); Thromboembolism (2654); Ischemia Stroke (4418); Embolism/Embolus (4438)

Event Date 10/23/2013

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that a (b)(6) year old patient underwent n-bca embolization of vein of galen aneurysmal malformation with use adenosine treatment and post op suffered clotting of the venous pouch and formation of a right basal ganglia and a left frontal venous infarction with early hemorrhagic transformation.Furthermore, embolic material was seen inside the falcine sinus and the torcula, causing at least partial outflow obstruction.The patient was eventually discharged to a rehabilitation facility and his clinical condition progressively improved to the point where he was neurologically intact at his 6 month clinical follow-up.Follow-up angiography also demonstrated 100% occlusion of the lesion.Model and catalog number are not available, but the suspected device is trufill n-bca.Other cnv devices that were also used in this study: envoy catheter, non-cnv devices that were also used in this study: unknown brand 7 french (f) sheath, unknown brand 6f sheath, unknown brand guide wire, marathon microcatheter, synchro-10 microwire, publication details.Title: the use of adenosine in the treatment of a high-flow vein of galen malformation in an adult.Objective: vein of galen aneurysmal malformations (vgam) are complex, high-flow arteriovenous malformations of the brain that have been described since the late 19th century, and they are diagnosed almost exclusively in children.The operative mortality approximates 90%.They are now treated almost exclusively via the endovascular route.The intravenous (iv) use of adenosine has been described in the literature when temporary flow arrest needs to be achieved, such as in embolization of high-flow arteriovenous malformations, operative treatment of intracranial aneurysms, and various open cardiothoracic and systemic interventional procedures.To our knowledge this is the first report describing the use of iv adenosine in the treatment of a very high-flow vgam in an adult patient.Methods: review of case report.

• Brand Name: UNK LIQUID EMBOLIC
• Type of Device: TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 10889380
• MDR Text Key: 219127205
• Report Number: 1226348-2020-00477
• Device Sequence Number: 1
• Product Code: KGG
• Combination Product (y/n): N
• PMA/PMN Number: P990040
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LIQUID EMBOLIC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVOY CATHETER; MARATHON MICROCATHETER; SYNCHRO-10 MICROWIRE; UNKNOWN BRAND 6F SHEATH; UNKNOWN BRAND 7F SHEATH; UNKNOWN BRAND GUIDE WIRE
• Patient Outcome(s): Life Threatening
• Patient Age: 37 YR