MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Model Number SECX-10-40-135

Device Problem Activation Failure (3270)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.(b)(4).

Event Description

This procedure was performed in (b)(6).On (b)(6) 2015, the protege rx stent was used for the procedure.There was no resistance during deployment of the stent.The lesion was calcified, but not circumferentially.The lesion was predilated with a 3x30 balloon and a 4x30mm balloon was used for post-dilatation but the stent was not dilated enough, so an additional 5x20mm balloon was additionally used to complete the dilatation.The procedure was completed without any adverse issue; however, the stent seemed doubled through echo image taken on (b)(6) 2015.On the following day, an image was taken, and it was confirmed the stent was deformed into a heart shape.The patient is currently on 2 antiplatelet agent pills.The physician noted the stent did not expand enough where the vessel was calcified, but it expanded where there was no calcification.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane n; plymouth MN 55442
• Manufacturer Contact: mary haufek ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5232457
• MDR Text Key: 31464217
• Report Number: 2183870-2015-07547
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2017
• Device Model Number: SECX-10-40-135
• Device Catalogue Number: SECX-10-40-135
• Device Lot Number: A087090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2015
• 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: 00072 YR