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

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

Patient Problems Bradycardia (1751); Stroke/CVA (1770); Loss of consciousness (2418)

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Authors: takuma nishimoto, fumiaki oka, koki okazaki, hideyuki ishihara journal name: neuroradiology year: 2022 literature title: relationship between cerebral hyperperfusion syndrome and the immediate change of cerebral blood flow after carotid artery stenting evaluated by single-photon emission computed tomography literature reference: doi.Org/10.1007/s00234-021-02822-8.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted for review titled: relationship between cerebral hyperperfusion syndrome and the immediate change of cerebral blood flow after carotid artery stenting evaluated by single-photon emission computed tomography.The aim of this study was to evaluate the immediate changes in cerebral blood flow (cbf) after carotid artery stenting (cas) and subsequent cbf changes in patients with cerebral hyper-perfusion (hp) using an i-imp spect.A total of 223 patients with chronic extracranial carotid artery stenosis who underwent cas were included in this study.Depending on the nature of the lesion, five types of embolic protection devices could be selected.One device that could be selected was distal balloon protection using percusurge guardwire (n=112).Other options were distal filter protection using a non mdt device (n=90); proximal balloon protection using non mdt device and distal balloon protection using percusurge guardwire (n = 12); proximal balloon protection using a non mdt device and distal filter protection using a non mdt device (n = 5); or proximal balloon protection using moma ultra (medtronic) and distal filter protection using a non mdt device (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, two of which were non mdt and one was a medtronic stent - protege (n = 20).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).All patients received maintenance oral antiplatelet treatment starting on the day after the procedure.Of the 223 patients, 5 had cerebral hyper-perfusion (hp).Of the 5 patients with hp, 4 developed cerebral hyper-perfusion syndrome (chs), whereas none of the 218 patients without hp had development of chs.Of 4 patients with chs, case 1 experienced headache 4 hours after cas with a 59.2% quantitative increase in cbf.Case 2 had eye pain and deterioration of consciousness 2 hours 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.Case 4 experienced headache and ct showed intracerebral hemorrhage 2 days after cas with a 73.0% increase in cbf.Intraoperative hypotension occurred in 102 cases.Bradycardia occurred in 70 cases.Hypotension and hypertension at the end of cas were present in 27 and 21 cases respectively.

• 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: 14875287
• MDR Text Key: 295047502
• Report Number: 1220452-2022-00056
• 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: 06/30/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 06/30/2022
• 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: 74 YR
• Patient Sex: Male