MAUDE Adverse Event Report: COVIDIEN PROTEGE RX; CAROTID STENT

Model Number SECX-10-60-135

Device Problems Collapse (1099); Folded (2630); Material Deformation (2976)

Patient Problems Thrombosis (2100); Weakness (2145); Stenosis (2263)

Event Date 12/08/2008

Event Type  Injury  

Event Description

Literature review: the date of the stent implantation is not known.Segmental stenosis was seen in left common carotid artery angiography and plain film showed carotid stent was placed with fully expansion.After 4 years, a sudden neurological episode occurred, characterized by the right hand weakness.Mri revealed an embolic infarction in the left precentral gyrus.Plain radiography revealed that the medial side of carotid stent was folded longitudinally in half, and this collapsed side was abutting on lateral side of the stent.Intraluminal filling defect in distal segment of stent (f) was present.Angiography confirmed the stented segment was separated into two stenotic lumens and in-stent thrombosis along the whole segment of the implanted stent.Computed tomography angiography (cta) source images showed significantly eccentric stenosis of 40-mm length, and neither calcification nor external mass around stenotic segment of left common carotid artery occurred.The left cca angiography confirmed extensive in-stent thrombosis with longitudinal folding deformation of the stent, and clopidogrel (75 mg/day) was administered immediately.The patient remained asymptomatic during 12 months of follow-up after discharge.

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.

Manufacturer Narrative

This supplemental mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.

• Brand Name: PROTEGE RX
• Type of Device: CAROTID STENT
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie riley ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 4387829
• MDR Text Key: 5301480
• Report Number: 2183870-2015-00001
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SECX-10-60-135
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 68