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

Model Number SECX-10-60-135

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2015

Event Type  malfunction  

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).During procedure, the physician initially placed a 10-40 stent (non covidien stent) in the distal internal carotid artery through the bifurcation area.However, the stent was not covering the target lesion completely.As a result the physician decided to deploy an additional stent.The first stent attempted (non covidien/medtronic stent) could not cross the original stent that was deployed.As a result a guiding catheter and wire were used to cross the lesion and a 4x40 (non covidien/medtronic) balloon was inflated.The balloon did not inflate as expected so an additional 5x40 (non covidien/medtronic) balloon was used.Next the physician chose to use a protege rx stent.Due to tortuous anatomy, the tip of protege rx was shaped a little bit in order to advance through original stent.The physician managed to deliver the protege to the target lesion and deployed it successfully without post dilatation.The physician was planning to deliver a guidewire as distal protection but gave up since there was no collateral circulation.The procedure was completed.After a few days, echo image was taken and an abnormality of protege rx stent was noticed.Ct image was taken im mediately and the physician confirmed the protege rx stent was fractured.No medical intervention was required.

Manufacturer Narrative

This 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.

Event Description

Cine image review: multiple cine images of the deployed stent were provided by the customer.The cine images were reviewed and observed.The stent showed serpentine bending and compression of the struts in the center portion of the deployed stent.No fracture of the struts could be clearly identified.From the review of the cine images, no elongation of the deployed stent was noted and there is no indication that there were any issues deploying the stent.

• 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: 5322577
• MDR Text Key: 35012785
• Report Number: 2183870-2015-07616
• 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: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2016
• Device Model Number: SECX-10-60-135
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: 9881082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2014
• 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