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

Catalog Number SEBX-7-40-135

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

Patient Problems Chest Pain (1776); Thrombus (2101); Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 06/17/2016

Event Type  Injury  

Manufacturer Narrative

Event date: date of article publication (b)(4) surgical management for retained distal embolic protection device and fractured guidewire after carotid artery stenting journal of surgical case reports (2016) 6:1¿3 10.1093/jscr/rjw105.If information is provided in the future, a supplemental report will be issued.

Event Description

A (b)(6) male in (b)(6) underwent carotid artery stenting(cas) via transfemoral approach for severe (>90%) asymptomatic right internal carotid artery (ica) stenosis.A 5-mm spiderfx distal filter embolic protection device (epd) and a protégé 8 × 30 mm rx stent were used for the procedure.During deployment, this stent inadvertently migrated cephalad and became lodged onto the epd.Despite multiple attempts, the epd was unable to be retrieved with the capture sheath.The physicians placed another 7 × 40 mm protégé rx stent in the right ica to compress the epd and guidewire against the arterial wall, which was placed at the c1¿c2 vertebral level, superior to the first implanted protégé stent.At time of discharge, the ica stenosis had not been resolved.One month after discharge, the patient began experiencing substernal chest pain radiating to the neck with right suborbital pain.It was discovered that the guidewire had fragmented into three pieces.Upon presentation, the patient had moderate (55%) stenosis in the right common carotid artery (cca) and severe (90%) stenosis in the ica.The inferior fragment (known as fragment c) extended from the right femoral artery to the thoracic aorta, where it punctured the proximal aortic arch wall.Thrombus had also formed along the entire 1-meter length of fragment c.Carotid endarterectomy (cea) was performed at the right ica, after which the first stent was cut open longitudinally and excised.The second stent had accrued significant thrombotic material since the initial stenting procedure, so it could not be removed safely.So, the second stent and the edp were left intact.The second stent was anchored to the artery using prolene sutures.After 1-week recovery in icu, the patient returned to the or for removal of the fragment known as fragment c as it was piercing the aortic arch.This was done without incidence.After surgery, the patient reported alleviation of his symptoms.30 months post-operatively, the second stent is still in place.Over 3 years after surgery, no complications have been reported.

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): COVIDEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8227388
• MDR Text Key: 132394896
• Report Number: 2183870-2019-00012
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEBX-7-40-135
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• 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: 57 YR