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 Reocclusion (1985); Thrombosis (2100)

Event Date 03/02/2017

Event Type  Injury  

Event Description

Subjects were admitted for mri and dsa examinations, and to evaluate the safety and efficacy of endovascular treatment of diagnosed iih (idiopathic intracranial hypertension).According to the diameter of the sinus adjacent to the stenosis, a 6¿8 mm balloon was navigated over the microguidewire and inflated across the stenosis followed by the implantation of a self expanding stent.Non-medtronic and protégé stents were used in this study.Post-dilatation was not required.One patient presented a subacute thrombosis of the femoral vein despite anticoagulation.In-stent stenoses were encountered in 5/48 patients with dsa follow-up (10.4%).These in-stent stenoses were found 22, 8, 18, 4, and 11 months after the deployment of the concerning stent.All five patients with in-stent stenoses were symptomatic.Recurrent symptoms were found in three patients, and two patients with in-stent stenosis had persistent symptoms.In all five patients balloon angioplasty of the in-stent stenosis was performed, which resulted in a significant enlargement of the sinus lumen in all cases.Recurrent in-stent stenosis was observed and treated in two patients.In the first patient, instent stenosis was observed 18 and 79 months after the stent deployment and 61 months after the first balloon angioplasty, and in the second patient, in-stent stenosis was observed 4, 48, and 68 months after the stent-deployment and 42 and 64 months after the first balloon angioplasty.De novo stenoses distal to the previously implanted stent were observed in seven of the 48 patients (14.6%).Of these seven patients, four were asymptomatic despite the de novo stenosis.Recurrent symptoms were found in three patients and a new stenting was performed in all of them.No peri- and postprocedural complications occurred during a total of 12 retreatments.

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 n; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane n; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6586620
• MDR Text Key: 75815421
• Report Number: 2183870-2017-00220
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• 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: 04/24/2017
• 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: 40 YR