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 Bradycardia (1751); Stroke/CVA (1770); Headache (1880); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Pain (1994); Loss of consciousness (2418)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Relationship between cerebral hyperperfusion syndrome and the immediate change of cerebral blood flow after carotid artery stenting evaluated by single-photon emission computed tomography neuroradiology (2022) 64:1157¿1164.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 discussing the 'relationship between cerebral hyperperfusion syndrome and the immediate change of cerebral blood flow after carotid artery stenting evaluated by single-photon emission computed tomography' a retrospective chart review was performed for 223 patients with chronic extracranial carotid artery stenosis treated with cas at a hospital between march 2010 and march 2020.For at least 7 days before cas, each patient received oral dual antiplatelet treatment of aspirin (100 mg/day), clopidogrel (75 mg/day), or cilostazol (200 mg).Under local anesthesia, all procedures were performed using a femoral approach with an 8-ft-long sheath.At the beginning of the procedure, heparin was given intravenously to achieve an activated clotting time>250 s.The 8-ft-guiding catheter was introduced into the ipsilateral common carotid artery.Depending on the nature of the lesion, the operators selected from five types of embolic protection devices: distal balloon protection using percusurge guardwire (medtronic ave; n=112); distal flter protection using filterwire ez (boston scientifc; n=90); proximal balloon protection using optimo (tokai medical products) and distal balloon protection using percusurge guardwire (n=12); proximal balloon protection using optimo and distal flter protection using filterwire ez (n=5); or proximal balloon protection using mo.Ultra (medtronic) and distal flter protection using filterwire ez (n=4).In most cases, a 3.0- or 3.5-mm balloon catheter was used to predilate the stenosis.Three types of stents were placed in the stenotic lesion: precise (cordis; n=74); protege (medtronic; n=20); or wallstent (boston scientific; n=129).Post-dilation was performed with a percutaneous transluminal angioplasty balloon for residual stenosis.When a distal balloon protection device was used, an aspiration catheter was used to remove debris from the treated vessel before the balloon was deflated and antegrade flow in the vessel was restored.The median total occlusion time was 9 min (8¿11 min).The final residual stenosis rate (%) was evaluated using nascet measurement criteria by complete angiography.All patients received maintenance oral antiplatelet treatment starting on the day after the procedure.Postoperative mri was performed within 3 days after cas.A difusion-weighted imaging (dwi)-positive lesion was defined as a lesion with a high intensity in the hemisphere ipsilateral to the treated carotid artery stenosis territory.Of the 223 patients, 3 with pacemakers were excluded from analysis because mri was not performed.Therefore, postoperative dwi-positive lesions were evaluated in 220 patients.An increase in quantitative cbf occurred in 111 (49.8%) patients and a decrease occurred in 112 (50.2%).Of the 5 patients with hp, 4 (80%) developed chs, whereas none of the 218 patients without hp had development of chs.Of 4 patients with chs, case 1 experienced headache 4 h after cas, with a 59.2% quantitative increase in cbf, case 2 had eye pain and deterioration of consciousness 2 h after cas, with a 53.7% increase in cbf, case 3 had deterioration of consciousness with restlessness 1 day after cas, with a 79.7% increase in cbf, and case 4 experienced headache and ct showed intracerebral hemorrhage 2 days after cas, with a 73.0% increase in cbf.Intraoperative hypotension and bradycardia occurred in 102 (45.7%) and 70 (31.4%) cases, and hypotension and hypertension at the end of cas were present in 27 (12.1%) and 21 (9.4%) cases, respectively.The final residual stenosis rate was 6.0% (0.0¿19.5%).Of 220 patients who underwent mri, 20 (9.1%) had a postoperative dwi-positive lesion, and 3 patients with pacemakers did not develop hp.

• 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: 14975311
• MDR Text Key: 295602842
• Report Number: 2183870-2022-00224
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• 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: 06/15/2022
• 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 Age: 74 YR
• Patient Sex: Male