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

Catalog Number SECX-8-6-40-135

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2016

Event Type  malfunction  

Event Description

The physician was attempting to deliver a stent to the carotid artery due to a lesion that where re-stenosis was observed.The target lesion (target lesion: r-eca through cca, restenosis of cea) was located at bifurcation of ica through cca.Since the diameter of proximal and distal lesion differed, tapered stent was used.Lesion was slightly calcified.(cca: approximately 5.5 mm, ica: little less than 4.0mm, the total length of the lesion: 30mm.Eca distal 3.21 mm, most narrowed section 1.75mm, cca 6.39 mm).Pre-dilatation was performed with 3 x 40 mm balloon and the pre-dilatation and stent deployment were successful and post dilatation was not needed.The procedure was completed.The device was prepped and inspected with no issues noted.There was no resistance encountered.The vessel was not tortuous.There was nothing abnormal observed on the angiographic image taken post intervention.Approximately three days later, 3d ct was taken and the distal of the stent was found deformed inward, distal end of the stent through the bifurcation.The proximal section was fine.The stent is remains inside the patient.No further clinical sequelae reported for this event.

Manufacturer Narrative

Additional information received: a carotid guardwire was used as protection device.Dapt has been continued.Dapt is usually provided for all the cases for 6 months post intervention in this facility.The physician hasn't decided yet if dapt treatment should still be continued after 6 months.Cine image review: a series of cine and 3d ct images were received for evaluation.The images depict the targeted lesion located at the bifurcation of the ica through cca.The lesion shows signs of calcification.The images contain an image of the sizing measurements and stent implanted.The stent exhibits a fold running from the calcified lesion to the proximal end of the stent.The distal end of the stent is approximately 4.7mm and the proximal end of the stent is approximately 7.2mm.A 6mm diameter stent should be used in vessels approximately 4.5mm to 5.5mm in diameter.An 8mm diameter stent should be used in vessels 6.5mm to 7.5mm in diameter.

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 north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5849685
• MDR Text Key: 51243354
• Report Number: 2183870-2016-00553
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/1980
• Device Catalogue Number: SECX-8-6-40-135
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Date Device Manufactured: 12/31/1980
• 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