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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Transient Ischemic Attack (2109); Embolism/Embolus (4438)

Event Date 01/07/2021

Event Type  Injury  

Manufacturer Narrative

Journal article: efficacy of pretreatment with the free radical scavenger, edaravone, for prevention of cerebral hyperperfusion after carotid artery stenting: a single-center randomized controlled trial.Journal: interdisciplinary neurosurgery: advanced techniques and case year: 2021 ref: doi.Org/10.1016/j.Inat.2021.101092.Patient age: average age.Sex: majority gender.Event date: date of publication.

Event Description

A journal article titled - efficacy of pretreatment with the free radical scavenger, edaravone, for prevention of cerebral hyperperfusion after carotid artery stenting: a single-center randomized controlled trial - was submitted for review.This is a randomized controlled trial (rct) of 51 patients which aimed to evaluate whether pre-treatment with a free radical scavenger, edaravone, can prevent cerebral hyperperfusion (chp) after carotid artery stenting (cas).The medtronic guardwire embolic protection device was among the devices used during the procedures for distal protection.One patient experienced an embolic complication during cas and could not be included in the trial.Perioperative complications occurred in 3 patients: 2 had ischemic stroke or transient ischemic attack, and one patient had retroperitoneal hemorrhage caused by femoral artery puncture site bleeding.Of the 51 patients, 3 had chp, including one with transient postprocedural hypotension.The trial was stopped ahead of schedule due to poor recruitment.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12231670
• MDR Text Key: 264275736
• Report Number: 1220452-2021-00029
• 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: 07/27/2021

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: 07/09/2021
• Initial Date FDA Received: 07/27/2021
• 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 Age: 73 YR