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 Occlusion (1984); Pain (1994); Renal Failure (2041); Sepsis (2067); 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 cardiovascular surgeon in practice 16 years: physician has been both protégé rx self-expanding peripheral and carotid stent system and protégé gps self-expanding peripheral and biliary stent systems since 2018, using 40 protégé rx self-expanding peripheral and carotid stent systems and 30 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: 10 to treat occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); 20 to treat lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries; and 10, 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: 10 occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta), 10 lesions that appear to be at high risk for restenosis following pta in the common iliac, external iliac, or subclavian arteries, and 10 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 (with or without transfusion) (5 patients), sepsis (4 patients), shock (4 patients), and stroke (4 patients).Related to pta and stent placement, amputation (4 patients), detachment of a component of the delivery system (3 patients), renal insufficiency (new or worsening) (4 patients), stent damage or entanglement (6 patients) are reported complications which have been deemed associated.Amaurosis fugax (2 patients), emergent or urgent endarterectomy surgery (cea) (3 patients), severe unilateral headache (3 patients), total occlusion of carotid artery (3 patients) are reported as complications associated with carotid interventions.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 from anticoagulant or antiplatelet medications (1 patient), bleeding (with or without transfusion) (2 patients), contrast media reactionor renal failure (1 patient) , death (1 patient), inflammation (1 patient), ischemia or infarction of an organ or tissue (1 patient), seizure (1 patient).During pta and stent placement the following complications are deemed associated: renal insufficiency (new or worsening) (2 patients), stent misplacement (2 patients), vessel spasm or recoil (1 patient).Complication associated with biliary interventions reported: duct rupture resulting from overstretching the duct (3 patients), and infection (for biliary placement, secondary to contamination of the stent led to cholangitis, hemobilia, peritonitis, or abscess) (3 patients) of the above ae¿s reported for both the protégé rx self-expanding peripheral and carotid stent system, and the protégé gps self-expanding peripheral and biliary stent system; some of these are listed as having been previously reported to medtronic.Due to limited information these are included in reporting.

• 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: 8576873
• MDR Text Key: 143942628
• Report Number: 2183870-2019-00210
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• 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