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

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Pulmonary Embolism (1498); Bradycardia (1751); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Title: endovascular treatment for near occlusion of the internal carotid artery: 30-day outcome and long-term follow-up journal: clinical neuroradiology doi 10.1007/s00062-016-0546-8 clin neuroradiol (2018) 28:245¿252 a2: event date=date of literature article publication.If information is provided in the future, a supplemental report will be issued.

Event Description

Title: endovascular treatment for near occlusion of the internal carotid artery: 30-day outcome and long-term follow-up journal: clinical neuroradiology background the treatment strategy and the correct incidence of near occlusion (no) of the internal carotid artery (ica) is still controversial.In routine radiological imaging no can easily be misdiagnosed as complete occlusion and there is no consensus on the standard treatment strategy.Purpose to present our perioperative and long-term followup results of ica no patients treated with carotid artery stenting (cas).Material and methods between 2004¿2014 a total of 182 patients with ica no were evaluated for cas.The study included 132 male (72.5 %) and 50 female (27.5 %) patients with a mean age of 70.2 years.Patients underwent a clinical neurological evaluation and radiological imaging of the carotid arteries before the cas procedure.Of the patients 80 (44 %) were asymptomatic.The median clinical and carotid doppler ultrasound (dus) follow-up period was 64 months (range 18¿124 months).Results in 182 patients cas were performed, 4 patients (2.2 %) developed minor stroke, 2 patients (1.1 %) developed myocardial infarction but no major stroke or death occurred in the following 30-day period.Asymptomatic restenosis was detected in seven patients (3.8 %) in the follow-up period.Conclusion with sufficient neurological evaluation during pretreatment and post-treatment periods and when the procedure is performed with technologically developed products by an experienced interventional team, cas is beneficial in patients with ica no event description: a percutaneous transfemoral approach was used for cas in all cases via the long (6 f or 7 f, 90 cm) non-mdt introducer sheath.All procedures were performed with monorail systems for stent placement, distal protection (using mdt spider embolic protection in some cases) and for predilation and postdilation.In cases where there was difficulty crossing the lesion with the embolic protection, the lesions would be further pre-dilated and in all cases the embolic protection could then be passed.After pre-dilatation, intimal dissection was seen in 29 patients which was treated with stenting.The angiography after stent deployment and post-dilatation showed filter occlusion in 8 patients.Further clinical events including minor ipsilateral stroke, myocardial infarction and ipsilateral major stroke.Restenosis was determined in the 3-month follow-up in 1 patient and after 1-year follow-up in the remaining 6 patient.Restenting intervention was performed on the patients with restenosis using either or a non-mdt stent or a protege stent and post dilation.Stenting/postdilatation stages of the intervention were under filter protection in all cases.During the follow-up period 21 patients died, 12 from vascular causes (8 myocardial infarctions and 4 pulmonary embolism) and 9 from nonvascular diseases.

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 n nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 n nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7674116
• MDR Text Key: 113619160
• Report Number: 2183870-2018-00373
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• 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: 08/08/2018
• 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: 70 YR