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 Angina (1710); Arrhythmia (1721); Embolism (1829); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Pain (1994); Blood Loss (2597); Patient Problem/Medical Problem (2688)

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 29 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 2018, using 250 protégé rx self-expanding peripheral and carotid stent systems and 50 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: 50 to treat occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); 80 to treat lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries; and 120, 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: 30 occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta), 15 lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries, and 5 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: angina (1 patient), arrhythmia (2 patients), bleeding from anticoagulant or antiplatelet medications (1 patient), stroke (1 patient), and venous thromboembolism (1 patient).It is reported a failure to deploy event (1 patient) also occurred and is reported as being associated with pta and stent placement.The reported stroke and venous thromboembolism were unexpected events as was the failure to deploy event.Other complications associated with carotid interventions are hypotension or hypertension (1 patient), pain (head, neck) (3 patients), severe unilateral headache (2 patients).During use of the protégé gps self-expanding peripheral and biliary stent system, the following complications were encountered and deemed associated with the percutaneous procedure: bleeding (with or without transfusion) (1 patient), fever (2 patients), inflammation (1 patient), and sepsis (1 patient).Restenosis of the stented segment, and stent misplacement are also reported in one patient each during use of the protégé gps during pta and stent placement.Complication associated with biliary interventions is reported as infection (for biliary placement, secondary to contamination of the stent led to cholangitis, hemobilia, peritonitis, or abscess) which occurred in 1 patient.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)except for the failure to deploy, and stent misplacement events, all complications (adverse events) encountered were reported as being not device related at all.

• 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: 8594220
• MDR Text Key: 144542266
• Report Number: 2183870-2019-00221
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2019
• 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