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

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

Patient Problems Embolism (1829); Fever (1858); Occlusion (1984); Thrombus (2101); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the protégé peripheral stent systems (the gps self-expanding peripheral and biliary stent system and the protégé rx self-expanding carotid stent system).Survey results from a vascular surgeon in practice 17 years: physician has been using both protégé rx self-expanding peripheral and carotid stent system and protégé gps self-expanding peripheral and biliary stent systems since 2013, using 60 protégé rx self-expanding peripheral and carotid stent systems and 110 protégé gps self-expanding peripheral and biliary stent systems within the last year.The protégé rx self-expanding peripheral and carotid stent systems were used as follows: 20 to treat occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); 10 to treat lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries; and 30, to treat stenoses of the common carotid artery (cca), internal carotid artery (ica), and carotid bifurcation the protégé gps self-expanding peripheral and biliary stent system was used to treat: 89 occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta), 20 lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries, and 2 palliative treatment of malignant neoplasms in the biliary tree.During use of the protégé rx self-expanding peripheral and carotid stent system, the following complications were encountered and associated with any percutaneous procedure: bleeding from anticoagulant or antiplatelet medications (1 patient), bleeding (with or without transfusion) (1 patient), embolism (1 patient), fever (2 patients), and intraluminal thrombus (1 patient).Events such as abrupt or subacute closure (1 patient), restenosis of the stented segment (3 patients), stent migration (1 patient), stent misplacement (1 patient), thrombosis or occlusion of stent (2 patients), and vessel spasm or recoil (1 patient) are reported as being associated with pta and stent placement.Reported complications with carotid interventions are reported as cerebral edema (1 patient), hyperperfusion syndrome (1 patient), severe unilateral headache (1 patient), and total occlusion of carotid artery (1 patient) during use of the protégé gps self-expanding peripheral and biliary stent system, the following complications are reported as deemed associated with the percutaneous procedure: bleeding from anticoagulant or antiplatelet medications (3 patients), bleeding (with or without transfusion) (1 patient), embolism (1 patient), fever (5 patients), and intraluminal thrombus (1 patient).Complications of: abrupt or subacute closure (1 patient), restenosis of the stented segment (1 patient), stent migration (1 patient), stent misplacement (1 patient) and thrombosis or occlusion of stent (1 patient) have been reported as being associated with pta and stent placement.No complications are reported associated with biliary interventions.All complications (adverse events) encountered were reported as being not device related at all.

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: 8599376
• MDR Text Key: 144690014
• Report Number: 2183870-2019-00254
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2019
• 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