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); Hemorrhage/Bleeding (1888); Ischemia (1942); Stenosis (2263); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Title: endovascular recanalization of symptomatic chronic ica occlusion: procedural outcomes and radiologic predictors authors: c zhou, y-z cao , z-y jia journal: original research interventional year: 2023 ref: doi: 10.3174/ajnr.A7804 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received an article titled 'endovascular recanalization of symptomatic chronic ica occlusion: procedural outcomes and radiologic predictors'.This study included 47 consecutive patients with symptomatic chronic ica occlusion who underwent endovascular recanalization.R protégé stent (medtronic) was among the stents used during the procedure.A spiderfx embolic protection device (medtronic) was typically used if short occlusions without tandem lesions and an adequate landing zone were identified.The mo.Ma occlusion system (medtronic) was sporadically used to protect against embolization in cases with suspected unstable thrombosis.47 patient were treated for ica occlusion.A total of 35 (74.5%) patients achieved successful recanalization.After the wires crossed the occlusion, embolic-protection devices were used in 34.3% (12/35) of patients: ten patients received the spiderfx device and 2 received the mo.Ma occlusion system.The overall intraoperative complication rate was 12.8% (6/47); 1 patient had a slight subarachnoid hemorrhage followed by microwire perforation, 3 patients had asymptomatic dissection (2 of whom were treated with stent implantation), and 2 patients had distal embolization.Neither of the latter 2 patients exhibited new neurologic symptoms with successful mechanical thrombectomy.The rate of stroke or death within 30 days was 6.4% (3/47).One older adult patient died of massive reperfusion hemorrhage 1 day after the procedure.The other 2 patients developed new neurologic symptoms 2 and 10 days after their procedures (their mrs scores were 2 and 4, respectively).Ctp revealed significant hypoperfusion on the recanalization side, and cta showed in-stent thrombosis.The symptoms of both patients improved after emergency mechanical thrombectomy (local arterial thrombolysis combined with balloon dilation) and subsequent drug and rehabilitation treatment.No strokes or deaths occurred during hospitalization in the failed recanalization group.At the 3-month follow-up, 21 of 29 patients having undergone recanalization (72.4%) with preoperative mrs scores of greater than or equal to 1 showed improvement in their mrs scores, whereas only 3 of 10 patients (30.0%) with failed recanalization and preoperative mrs scores of of greater than or equal to 1 showed improvement in their mrs scores.Restenosis or re-occlusion occurred in 12.9% of recanalized.Patients (4/31) who had follow-up imaging: three presented with asymptomatic re-occlusion, and the other presented with symptomatic restenosis (recurrent dizziness).The latter patient received subsequent balloon dilation therapy.No recurrent tia or stroke occurred in the other patients with successful recanalization during the clinical follow-up period.Of the 12 patients with failed recanalization, 3 patients (25.0%) experienced recurrent tia or stroke and 1 patient with stroke died despite aggressive medical management.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17118257
• MDR Text Key: 317076706
• Report Number: 2183870-2023-00212
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• 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: 05/15/2023
• 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