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 Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Transient Ischemic Attack (2109); Cerebral Hyperperfusion Syndrome (4404); Embolism/Embolus (4438); Retroperitoneal Hemorrhage (4483)

Event Date 01/07/2021

Event Type  Injury  

Manufacturer Narrative

Journal article title: efficacy of pretreatment with the free radical scavenger, edaravone, for prevention of cerebral hyperperfusion after carotid artery stenting: a single-center randomized controlled trial interdisciplinary neurosurgery volume 24, june 2021, 101092 https://doi.Org/10.1016/j.Inat.2021.101092.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to determine whether pre-treatment with a free radical scavenger, edaravone, could prevent cerebral hyperperfusion (chp) after carotid artery stenting (cas).Medtronic¿s protege rx self-expanding stent was used in the study.52 patients were split equally between the edaravone group and control group.The trial was stopped ahead of schedule due to poor recruitment.Among 52 participants, 51 completed the trial; 25 in the edaravone group, and 26 in the control group.The primary outcome was occurrence of chp immediately after cas.The secondary outcomes included post-cas cbf, post-cas ai, post-cas mca-to-cerebellar activity ratio, cbf change, ai change, and mca-to cerebellar activity ratio change.One patient in the edaravone group could not undergo single-photon emission computed tomography (spect) after cas due to an embolic complication during cas.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.3 patients had chp including one with transient postprocedural hypotension, but the patient¿s had no clinical symptoms.The author concluded pretreatment with edaravone appeared not to be associated with reduction in the occurrence of chp immediately after cas.

• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12224813
• MDR Text Key: 263438827
• Report Number: 2183870-2021-00255
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• 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: 07/09/2021
• 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