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); Transient Ischemic Attack (2109)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

As reported through literature, a patient presented with asymptomatic symptoms and was treated with a protégé rx carotid stent, a moma device and a spider device.It was reported that during the procedure, the patient suffered right hemiparesis aphasia (transient).No intervention was reported and no further patient injury reported for this event.

Manufacturer Narrative

Date of publication journal article title: postoperative ischemic events in patients undergoing carotid artery stenting using algorithmic selection for embolic protection the neuroradiology journal 2019, vol.32(4) 294¿302! the author(s) 2019 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/1971400919839644 journals.Sagepub.Com/home/neu.If information is provided in the future, a supplemental report will be issued.

• 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 ; 091708734
• MDR Report Key: 8929869
• MDR Text Key: 155503849
• Report Number: 2183870-2019-00417
• 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,Followup
• Report Date: 08/26/2019

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: 08/02/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 08/02/2019
• Supplement Dates FDA Received: 08/26/2019
• 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): Required Intervention
• Patient Age: 73 YR