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

Catalog Number UNK EMBOLIC AGENT

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

Patient Problem Aneurysm (1708)

Event Date 06/30/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Aneurysm recanalization, surgical intervention.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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿outcomes of type 2 endoleaks detected on venous phase ct arteriography.¿ 4 patients after endovascular aneurysm repair (evar) who complicated with type 2 endoleak (t2el) and who underwent endoleak embolization with a combination of platinum coils and nbca liquid embolic agent -trufill experienced aneurysm recanalization, , which was treated surgically by open repair.Purpose: the majority of type 2 endoleaks (t2el) are identified on computed tomography angiography (cta) both on arterial and venous phase.There is a subset of t2el that are demonstrated only on venous phase cta.This study was done to report the outcomes of t2el detected only on venous phase cta.Materials and methods: between october 2001 and june 2015 a total of 261 consecutive t2el treated via embolization were reviewed for the presence of endoleak demonstrated only on venous phase cta.A group of 16 patients (12 men, 4 women; mean age, 80.1 years) was identified who had pre-embolization venous phase t2el.Patients were evaluated for presence of t2el after embolization, change in aneurysm diameter, and need for further intervention.

• Brand Name: EMBOLIC AGENT
• 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
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9168214
• MDR Text Key: 170289738
• Report Number: 1226348-2019-00995
• Device Sequence Number: 1
• Product Code: KGG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK EMBOLIC AGENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR