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

Catalog Number SECX-10-60-135

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/21/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was attempting to implant a protege rx carotid stent system in the left ica with eccentric lesion, mild calcification with very few tortuosity.Lesion length was 30 mm.The physician approached from the upper arm.The intervention went smoothly until the pre-dilation; however, the physician felt resistance upon delivering the protege due to the tortuosity between subclavian and common carotid artery.The physician managed to deploy the stent and post-dilatation was performed.Then the physician started delivering the dual end catheter in order to retrieve the spider, but the catheter failed to pass through the stent.For that reason, the physician decided to perform post-dilation again and attempted delivering balloon.However, the balloon got stuck at the proximal area of the stent and did not pass through the stent.At this time, 3dct was taken, and the physician confirmed the target lesion and proximal area of the stent, about 40mm, was deformed inward; the middle section of the stent was deformed, about 10mm of the stent, both proximal end and distal end, was expanded.Another balloon was used to pass through the stent but failed.Eventually, a non-medtronic 5 x 20 mm balloon was opened and delivered.The device successfully passed through the proximal of the stent, and the physician dilated the stent from proximal little by little for total 5 times, and expanded the deformed section of the stent.The dual end catheter was successfully delivered, and the spider was retrieved without further issue.Then the procedure was completed.The patient was discharged from the hospital 1 week post intervention, dapt has been continued and patient condition is currently being monitored.

Manufacturer Narrative

Cine image review: ct scans from the procedure were received for evaluation.Ratio comparison of the length of the stent indicates that the majority of the targeted vessel anatomy the stent was oversized.The images show the non-concentric nature of the vessel even with the implanted stent.The images show the amount of inward protrusion of the stent in that section of the treated vessel.It is indicated that the stent is constricted in some sections.The profile of the stent exhibits a bifurcated heart shape.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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: 5888738
• MDR Text Key: 52517438
• Report Number: 2183870-2016-00574
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2016
• 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: 67 YR