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 Intracranial Hemorrhage (1891); Obstruction/Occlusion (2422); Restenosis (4576)

Event Date 07/01/2022

Event Type  Injury  

Event Description

Medtronic received a journal article 'carotid artery stenting for near occlusion with full collapse'.Between march 2007 and december 2020, 18 of 477 carotid artery stenting procedures were performed in patients with near occlusion with full collapse (3.8%).A total of 17 men and one woman with a mean age of 76.1 years were included.Eleven patients (61%) were symptomatic.The technical success rate, incidence of symptomatic stroke within 30 days, new ipsilateral ischemic lesions on diffusion tensor imaging within 48 hours after carotid artery stenting, and follow-up results (ipsilateral stroke rate and restenosis rate) were retrospectively assessed.Antiplatelet therapy consisting of oral administration of 2 drugs, aspirin (100 mg) and clopidogrel (75 mg) or cilostazol (200 mg), was started at least 7 days before the procedure.All procedures were performed by experienced interventionalists who had operated on more than 400 cas procedures.All cas procedures were performed under local anesthesia using an embolic protection device.The embolic protection devices used: angioguard xp (cardinal health and cordis, milpitas, ca, usa), filterwire ez (boston scientific, natick, ma, usa), moma ultra (medtronic, vascular, santa rosa, ca, usa), optimo (tokai medical products, kashugai, japan), and combined with moma ultra and filter ez.Cas was performed using a standard procedure.Before predilation, intravascular ultrasonography (ivus) was used to assess not only the distal ica normal lesion diameter, but also the healthy lumen of the distal ica.If the diameter of the stenotic lesion was not large enough to cross a filter device, predilation with a 2-mm balloon dilation was performed.Predilation of the stenotic lesion was performed in all cases with a 3-mm balloon to achieve an adequate lumen for crossing the stent catheter.The stent was deployed from the distal healthy lumen as far as possible.Stents used were carotid wallstent (boston sc.), precise (cordis), integrity <(>&<)> protégé.Regarding the diameter and length of the stent, a diameter 1 or 2 mm larger than the common carotid artery lumen at the full open position when placing the stent in the common carotid artery from the ica was chosen.When placement was in the ica only, a stent diameter (at the full open position) of 1 or 2 mm larger than the ica was selected.Stent length was selected so that the stent fully covered the region of stenosis.Therefore, in most cases, several stents were needed.In the case of several stents, the overlapped length of each stent was approximately 1 cm.The stent was then placed, and conservative postdilation was performed.Conservative postdilation means that the size of postdilation was no more than approximately 80% of the distal luminal diameter measured by ivus.If accurate measurement of the distal lumen by ivus was impossible for the collapsed lesion, a 4-mm diameter balloon was selected for postdilation in most cases based on the contralateral normal ica diameter.Regarding periprocedural management, systolic pressure was strictly controlled to be under 140 mmhg to prevent cerebral hyperperfusion syndrome (chs).The technical success rate was 100%.Symptomatic stroke was observed in 0 cases (0%) within 30 postoperative days.New ipsilateral ischemic lesions were observed in 16.7% (3/18) of patients.All ischemic lesions were asymptomatic.Asymptomatic minor cerebral hemorrhage occurred in 2 patients (11.1%).A spect study indicated the hyperperfusion phenomenon as the cause of minor cerebral hemorrhage.Blood pressure was strictly controlled in both patients for 1 week until chs disappeared.During the follow-up period (mean: 77 41.0 months, range: 2e140 months), asymptomatic restenosis of 53% on ultrasound occurred in one patient (5.5%), so this patient was followed up carefully.Asymptomatic occlusion occurred in one patient (5.5%).This patient had not been going to a hospital regularly and had not been taking an antiplatelet medicine.Therefore, follow-up ultrasound was obtained only 12 months after the cas procedure.The ultrasound indicated in-stent occlusion.Therefore, follow-up dsa was performed.Dsa showed complete occlusion from the ica origin to the cavernous portion of the ica.Three patients (16.7%) died from nonneurological causes during follow-up periods.

Manufacturer Narrative

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.

• 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: 15475363
• MDR Text Key: 300585966
• Report Number: 2183870-2022-00317
• 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,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male