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

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

Patient Problem Death (1802)

Event Type  Death  

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 23 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 2017, using 85 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: 35 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 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: 65 occlusions or lesions that are at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta), 35 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: artery dissection, flap, perforation or rupture (1 patient), contrast media reaction or renal failure (2 patients), death (1 patient), embolism (1 patient), inflammation (1 patient),intraluminal thrombus (2 patients), ischemia or infarction of an organ or tissue (1 patient), stroke ( 1 patient).Occurrences of restenosis of the stented segment, thrombosis or occlusion of stent are reported as being associated with pta and stent placement.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: artery dissection, flap, perforation or rupture (1 patient), contrast media reaction or renal failure (1 patient), death (1 patient), inflammation (1 patient), intraluminal thrombus (1 patient), ischemia or infarction of an organ or tissue (1 patient).An occurrence of thrombosis or occlusion of stent is reported as being associated with pta and stent placement.No complications are reported associated with biliary interventions.Of the above ae¿s reported for the protégé rx self-expanding peripheral and carotid stent system, the following (artery dissection, flap, perforation or rupture, intraluminal thrombus) are listed as having been reported to medtronic previously.Due to limited information these are included in reporting.Similarly, for the protégé gps self-expanding peripheral and biliary stent system the following complications are listed as being previously reported (artery dissection, flap, perforation or rupture, intraluminal thrombus, and ischemia or infarction of an organ or tissue).

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: 8573881
• MDR Text Key: 143845447
• Report Number: 2183870-2019-00203
• 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: Other
• 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: 05/02/2019
• 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?: No
• 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): Death; Required Intervention