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); Vascular Dissection (3160)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

Journal title: staged carotid artery stenting for prevention of hyperperfusion-induced intracerebral hemorrhage in patients with very high-grade carotid stenosis and poor collateral compensation shancai xu et al world neurosurgery, https://doi.Org/10.1016/j.Wneu.2022.11.057 a3: majority gender b3: date of publication.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

Hyperperfusion-induced intracerebral hemorrhage (hich) is a relatively rare but potentially devastating event after carotid artery stenting (cas).Staged angioplasty (sap), a 2-stage form of cas, has been shown to be effective for preventing cerebral hyperperfusion syndrome.This study investigated the safety and efficacy of sap to prevent hich in patients with severe carotid stenosis and poor collateral compensation.153 patients were involved.96 underwent regular cas and 57 underwent sap.Of the 57 patients scheduled for sap, 3 were switched to regular cas as a result of intraoperative dissection.One patient who was switched to regular cas experienced hich.Hich occurred in 1 patient (1.75%; 1/57) in the sap group and 12 patients (12.5%; 12/96) in the regular cas group (odds ratio 0.117,95% confidence interval 0.014-0.990, p = 0.049).1 patient died.For the regular cas procedure, under local anesthesia, femoral artery puncture was performed using the standard seldinger technique.An 8f guiding sheath was placed in the target common carotid artery.An embolic protection devices including spiderfx were navigated carefully and placed at 4-5cm at the distal end of the stenosis.The stenosis was predilated with a balloon of appropriate size, and the self expanding stents including protege were deployed.For the sap procedure, stage i (balloon angioplasty), an 8f guiding sheath was placed in the target common carotid artery.Distal embolic protection devices were used.A non medtronic balloon was inflated slowly at a rate of 1 atm per 3 seconds to the nominal pressure and was kept inflated for 30 seconds, followed by slow deflation of 1 atm per 3 seconds.The procedure was considered successful if the minimum luminal diameter exceeded 2.0 mm or the residual stenosis of <(><<)>70% on angiography and dissection was not observed after 20 minutes on repeat angiography.The operators decided to perform stenting during stage i if dissection occurred.In stage ii (cas), a self-expanding stent was deployed after predilatation with a semicompliant balloon.3 patients were switched to regular cas as a result of dissection.There was mild restenosis during the interval between the 2 stages.

• 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: 17640501
• MDR Text Key: 322145088
• Report Number: 2183870-2023-00307
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• 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
• Patient Sex: Male