MAUDE Adverse Event Report: COVIDIEN SPIDER FX

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

Patient Problem Pseudoaneurysm (2605)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

Published date carotid artery stenting with proximal embolic protection via the transbrachial approach: sheathless navigation of a 9-f balloon-guiding catheter neuroradiology (2018) 60:1097¿1101 https://doi.Org/10.1007/s00234-018-2085-2.If information is provided in the future, a supplemental report will be issued.

Event Description

A transbrachial cas technique with proximal protection by sheathless navigation of a 9-f balloon-guiding catheter with an outer diameter equivalent to a 7-f sheath was performed in 8 consecutive patients among 39 patients who underwent cas from april 2016 to june 2017.Medtronic devices such as carotid guardwire and spider fx were used during the procedure.Technical success was accomplished in all patients.For a patient who received treatment for a right side carotid stenosis which exhibited 63% stenosis with a type 3 aortic arch, a pseudoaneurysm at the access site was reported.The common carotid artery (cca) takeoff angle is reported as 45 degrees.This required ultrasound-guided compression.

• Brand Name: SPIDER FX
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8052106
• MDR Text Key: 126574651
• Report Number: 2183870-2018-00507
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• 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): Required Intervention
• Patient Age: 81 YR