MAUDE Adverse Event Report: COVIDIEN PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD; STENT, ILIAC

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

Patient Problems Fever (1858); Hematoma (1884); Thrombosis (2100); Thrombus (2101); Injury (2348); Vascular Dissection (3160)

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 medtronic¿s protégé rx self-expanding peripheral stent system and medtronic¿s protégé gps self-expanding peripheral stent system.Survey results are received for a vascular surgeon practicing in germany.The physician has been using the protégé rx self-expanding peripheral stent system since 2010 and the protégé gps self-expanding peripheral stent system since 2013 for the treatment of lesions that appear to be at high risk for restenosis following pta in the subclavian arteries.Within the last 12 months, the protégé rx self-expanding peripheral stent system was used for the treatment of lesions that appear to be at high risk for restenosis following pta in the subclavian arteries in 25 procedures.During use of the protégé rx self-expanding peripheral stent system, the following complications are reported: bleeding, (with or without transfusion) from puncture channel after pre-existing anticoagulation, fever (differential diagnosis for pneumonia), and hematoma (superficial in area of puncture site) events are reported.All of these events are reported to have been device related and are reported as being not at all concerning.Associated with stent placement an event of thrombosis or occlusion of the stent is reported to have occurred on the 3rd day post-interventional after suspended anticoagulation; resolved without problems by aspiration thrombectomy.The event was deemed device related and reported as being not at all concerning.The protégé gps self-expanding peripheral stent system was used in 20 procedures within the last 12 months for the treatment of lesions that appear to be at high risk for restenosis following pta in the subclavian arteries.Fever (differential diagnosis pneumonia), hematoma (superficial at puncture site), and intraluminal thrombus (without haemodynamic relevance - incidental finding ct thorax scan) events are reported as complications which were deemed device related and reported as being not at all concerning.Associated with stent placement events of dissection or intimal flap (resolved without problems after stent released), thrombosis or occlusion of the stent (asymptomatic after 3 months), and vessel spasm (without any clinical relevance observed at angio) are reported as complications which were deemed device related and reported as being not at all concerning.

• Brand Name: PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD
• Type of Device: STENT, ILIAC
• 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: 9232617
• MDR Text Key: 173184539
• Report Number: 2183870-2019-00521
• Device Sequence Number: 1
• Product Code: NIO
• 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
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• 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: 10/01/2019
• 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