MAUDE Adverse Event Report: COVIDIEN PROTEGE RX; CAROTID STENT

Model Number SECX-10-60-135

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

Patient Problem Infarction, Cerebral (1771)

Event Date 07/09/2014

Event Type  Injury  

Event Description

This procedure was performed in (b)(6).The procedure was a carotid artery stenosis/carotid artery stenting performed on (b)(6) 2014.There was 0% stenosis post procedure.It was reported that post-procedure the patient developed high order dysfunction and right hemiplasia.The physician said the infarction occurred in the area where the cas was performed and was treated with the administration of edaravone.The high order dysfunction was temporal and the patient recovered.However the patient still had mild right hemiplasia and the hospital stay was extended for rehab.Antiplatelet agents aspirin and clopidogrel were used.Please reference mdr 2183870-2015-00142 for the spiderfx used in the procedure.

Manufacturer Narrative

A review of the manufacture records for this device could not be conducted because the lot number was not available.(b)(4).

Manufacturer Narrative

(b)(4).

• 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: 4685561
• MDR Text Key: 5690436
• Report Number: 2183870-2015-00141
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/16/2015
• 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: 79 YR