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 Stroke/CVA (1770); Transient Ischemic Attack (2109); Restenosis (4576)

Event Date 04/21/2012

Event Type  Injury  

Manufacturer Narrative

Article title: factors affecting long-term restenosis after carotid stenting for carotid atherosclerotic disease neuroradiology (2012) 54:1347¿1353 doi 10.1007/s00234-012-1031-y.Average age, majority gender, date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing retrospective analysis of patients who underwent carotid artery stenting (cas) for carotid atherosclerotic disease.102 patients were included in the study with a total of 105 cas procedures performed.Medtronic¿s protégé carotid stent was amongst the devices implanted in the population.Approximately 92% of the stents used in the study were non-medtronic stents.Periprocedural complications included were stroke, 2.7 %, tia, 1.8 %; cardiac, 0.9 %; and others, 0.9 %), with permanent complications of 3.6 %.Restenosis was reported in 26.7% of cases, with 1.9% requiring endovascular intervention.The remainder were asymptomatic or managed with medical therapy.Two thirds of restenosis occurred within the first 8 months of the stenting, whereas in two of our patients, as late as 40 months from the initial stenting.Use of one identified non-medtronic stent was noted to be related to the prevalence of restenosis.

• 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 ; EI ; 091708734
• MDR Report Key: 12331132
• MDR Text Key: 266877171
• Report Number: 2183870-2021-00294
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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: 08/16/2021
• 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
• Patient Age: 71 YR