MAUDE Adverse Event Report: MEDTRONIC, INC EXPORT UNKNOWN; CATHETER, EMBOLECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Ischemia (1942)

Event Date 12/29/2022

Event Type  Injury  

Event Description

A journal article was submitted for review titled "the height and mobility of protruding plaque after carotid artery stenting are associated with postoperative ischemic lesions".The aim of this article was to investigate the relationship between the morphological features of tissue protrusion (tp) and postoperative new ischemic lesions on magnetic resonance imaging (mri) diffusion weighted imaging (dwi) after carotid artery stenting (cas).A total of 50 patients who underwent cas and subsequent post stenting intravascular evaluation using both optical frequency domain imaging (ofdi) and angioscopy were included in this study.Cas was performed for proximal protection via the femoral artery approach and intravascular evaluation with ofdi and angioscopy were performed after stent placement.The background and post-stenting intravascular findings between patients with and without postoperative new ischemic lesions on mri-dwi were compared.The patients with postoperative new ischemic lesions on mri-dwi were classified into the ¿dwi-positive group,¿ and those without were into the ¿dwi-negative group¿.The clinical outcomes measured as part of this study were stroke, myocardial infarction and death within 30 days of cas.Stroke was defined as ischemic or hemorrhagic stroke with neurologic impairment lasting more than 24 hours.The cas procedures were performed under local anesthesia by transfemoral artery access.Following the insertion of a 9fr sheath into the femoral artery, heparin was administered.The medtronic mo.Ma ultra system was used as proximal embolic protection with a flow reversal method.After pre-stenting balloon dilatation using a 3.5 x 4.5mm diameter balloon catheter, cas were performed using either non-medtronic stents (n=45) or the medtronic protégé stent (n=5).Following stent implantation, if there was a residual stenosis of 50% or more, measured by ivus, post stenting balloon dilatation was performed using a 3.5 x 5.5mm diameter balloon catheter.In the ofdi procedures, a non mdt ofdi system was used.After stenting, the ofdi imaging catheter was guided with a 0.014 guidewire to the internal carotid artery (ica) distal to the stenting site.The external carotid artery and common carotid artery were temporarily occluded by the mo.Ma ultra system to block blood flow from the proximal side of the common carotid artery and contrast medium diluted 50% with saline was injected for 5 seconds through the guiding catheter at 8 ml/s with a motor-driven injector.The ofdi image wire was scanned through the vessel lumen while being pulled back at a rate of 20 mm/s.The images at an acquisition rate of 158 fps were saved to the console of the ofdi system.The height of tp (mm) was measured as the maximum length protruding from the inner surface of the stent.The gap area (mm2) was defined as the area between the stent and the inner wall of the artery and was used as an indicator of incomplete stent apposition.In the angioscopy procedures, angioscopy was performed in addition to the ofdi procedure.To maintain a bloodless field of view, back flow from the distal ica was blocked with the medtronic carotid guardwire device.A medtronic 6-french export suction catheter was guided following the carotid guardwire and an angioscopy catheter was inserted into the suction lumen and guided distally to the stent.The saline solution was continuously injected manually to maintain a bloodless field of view while observing the lumen of the vessel.The occlusion of the carotid artery was intermittently performed and the total duration of carotid occlusion during cas procedures, including ofdi and angioscopy, was less than 10 minutes.Based on the video data captured by the angioscopy, the mobility of the protruding tissue was graded into the following 3 grades: grade 1: no mobility, grade 2: blood flow-related mobility, and grade 3: significant mobility or ruptured.Tp with grade 3 mobility was defined as mobile-tp1 all patients received postoperative dwi examination 1-3 days after the procedure.Tp was observed in 42 patients (84%).Postoperative new ischemic lesions detected by mri-dwi were observed in 32 patients (64%).These lesions were asymptomatic in 30 patients (60%) and symptomatic in 2 patients (4%).Details of the 2 patients who presented symptomatic stroke are as follows; the patient had multiple sporadic new ischemic lesions on mri-dwi in the ipsilateral parietal and bilateral frontal cortex and presented transient dysarthria postoperatively which improved by postoperative day 3.The other patient developed hemiparesis and dysarthria with multiple sporadic new ischemic lesions on mri-dwi in the bilateral frontal and ipsilateral occipital cortex, with residual dysarthria.There were no cases of myocardial infarction or deaths in the study.

Manufacturer Narrative

Title: the height and mobility of protruding plaque after carotid artery stenting are associated with postoperative ischemic lesions authors: kiyomitsu kano, yukiko enomoto, takamitsu hori, naoko funatsu, yusuke egashira, noriyuki nakayama, shinichi yoshimura, toru iwama journal name: world neurosurgery year: 2023 reference: doi.Org/10.1016/j.Wneu.2022.12.127 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.

Manufacturer Narrative

Additional information: annex d code.Correction: section 2: outcome attributed to adverse event, other selected.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: EXPORT UNKNOWN
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17038604
• MDR Text Key: 316391863
• Report Number: 1220452-2023-00059
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 06/30/2023
• 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): Other
• Patient Age: 77 YR
• Patient Sex: Male