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

Device Problems Fracture (1260); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 an interventional radiologist in practice 18 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 2015, using 80 protégé rx self-expanding peripheral and carotid stent systems and 70 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: 25 to treat occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); 30 to treat lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries; and 25, 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: 25 occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta), 25 lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries, and 20 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: arteriovenous fistula (2 patients), arrhythmia (5 patients), artery dissection, flap, perforation or rupture (2 patients), bleeding from anticoagulant or antiplatelet medications(5 patients), cerebral ischemia, or transient ischemic attack (tia) (2 patients), contrast media reaction or renal failure (4 patients), embolism (2 patients), hematoma (10 patients), myocardial infarction (1 patient), pseudoaneurysm (14 patients), and stroke (2 patients).Events such as partial stent deployment (6 patients), restenosis of the stented segment (12 patients), stent collapse or fracture (4 patients), surgical or endovascular intervention (10 patients), thrombosis or occlusion of stent (9 patients) are reported as being associated with pta and stent placement.Reported complications with carotid interventions are reported as hypotension or hypertension (20 patients), pain (head, neck) (12 patients), severe unilateral headache (12 patients), and slow or no flow during procedure (6 patients) 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: allergic reaction to device materials or procedure medications (8 patients), aneurysm (5 patients), artery dissection, flap, perforation or rupture (8 patients), bleeding from anticoagulant or antiplatelet medications (15 patients), bleeding (with or without transfusion) (15 patients), congestive heart failure (chf) (15 patients), contrast media reaction or renal failure (6 patients), fever (12 patients), hematoma (15 patients), hypertension or hypotension (20 patients), inflammation (8 patients), ischemia or infarction of an organ or tissue (5 patients), pseudoaneurysm (8 patients), sepsis (5 patients), venous thromboembolism (2 patients).Complications of: abrupt or subacute closure (5 patients), allergic reaction implant (due to allergy to nickel titanium ¿ nitinol) (1 patient), gastrointestinal bleeding due to anticoagulation (5 patients), renal insufficiency (new or worsening) (6 patients), renal failure requiring dialysis (3 patients), restenosis of the stented segment (8 patients), stent misplacement (2 patients), surgical or endovascular intervention (6 patients), thrombosis or occlusion of stent (3 patients), and vessel spasm or recoil (4 patients) have been reported as being associated with pta and stent placement.The following complications are reported for biliary interventions: duct rupture resulting from overstretching the duct (1 patient) and infection (for biliary placement, secondary to contamination of the stent led to cholangitis, hemobilia, peritonitis, or abscess) (5 patients).Of the above complications (adverse events) reported for the protégé rx self-expanding peripheral and carotid stent system and, protégé gps self-expanding peripheral and biliary stent systems some of these are listed as having been reported to medtronic previously.Due to limited information these are included in reporting.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8599300
• MDR Text Key: 144689789
• Report Number: 2183870-2019-00249
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1