MAUDE Adverse Event Report: MEDTRONIC, INC GUARDWIRE TEMPORARY OCCLUSION SYSTEM; CATHETER, EMBOLECTOMY

Catalog Number GEZUNK

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

Patient Problems Bradycardia (1751); Stroke/CVA (1770); Transient Ischemic Attack (2109); Insufficient Information (4580)

Event Date 04/20/2022

Event Type  Injury  

Manufacturer Narrative

Authors: yuyo maeda, shigeyuki sakamoto, takahito okazaki, and masashi kuwabara.Journal name: vascular and endovascular surgery.Year: 2022.Title of article: carotid artery stenting in patients with contralateral carotid occlusion using a combined protection method.Literature reference: doi: 10.1177/15385744221087814.Date of event is 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

A journal article was submitted for review titled: "carotid artery stenting in patients with contralateral carotid occlusion using a combined protection method".The aim of this study was to compare the clinical characteristics, treatment outcomes, and adverse events in patients with and without contralateral carotid occlusion (cco) to assess the safety of the dual protection and blood aspiration method of carotid artery stenting (cas) for carotid artery stenosis-contralateral carotid occlusion (ics-cco).The study was a retrospective single-center study which assessed 218 patients with internal carotid artery stenosis who underwent carotid artery stenting using the dual protection (simultaneous flow reversal and distal filter) and blood aspiration method.The patients were divided into two groups: ics and contralateral carotid occlusion (n = 11) (cco group) and patients with ics and no contralateral carotid occlusion (n = 207) (non-cco group).The mean degree of stenosis was 72.3% ± 16.2% in the cco group and 73.3% ± 18.9% in the non-cco group.During the procedure a 9fr non mdt occlusion balloon guide catheter was introduced into the common carotid artery via the femoral artery.Next, a guardwire temporary occlusion and aspiration system was introduced into the external carotid artery.The proximal end of the 9fr occlusion balloon guide catheter was connected to the 4fr sheath and was inserted into the femoral vein via the blood filter.Under flow reversal, a non mdt filter wire was placed into the most cranial part of the cervical internal carotid artery (ica).Under this dual protection, pre-dilation was performed, and a self-expanding non mdt stent was deployed.Post-dilation was performed with an angioplasty balloon with a diameter similar to that of the normal distal ica.An export advance aspiration catheter was then placed between the proximal end of the stent and the distal filter, and blood was aspirated several times from the ica.Anticoagulant medication was continued for 12 hours after cas.Dual-antiplatelet drugs were administered for the first 3 months post-procedure, followed by a single antiplatelet drug.Technical success was achieved in all cases.In the 11 patients in the cco group the following events were reported: intraoperative transient neurological symptoms (n=2), hypotension (n=5), dwi hyperintensities (n=3), intraoperative capture debris (n=2), restenosis (n=1).There were no cases of access related complications, major adverse events, minor strokes, and tia in the cco group.In the 207 patients in the non-cco group the following events were reported: intraoperative transient neurological symptoms (n=34), hypotension (n=63) and bradycardia (n=13).For the non-cco group, access-related complications (n=2), major adverse events (n=1), major stroke (n=1), minor strokes (n=5), tia (n=5), dwi hyperintensities (n=63), intraoperative capture debris (n=73), and restenosis (n=9) occurred.

• Brand Name: GUARDWIRE TEMPORARY OCCLUSION SYSTEM
• 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: 15884390
• MDR Text Key: 304507924
• Report Number: 1220452-2022-00089
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2022

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: Health Professional
• Device Catalogue Number: GEZUNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 11/30/2022
• 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): Other
• Patient Age: 72 YR
• Patient Sex: Male