MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Model Number SECX-6-30-135

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used a protégé rx self-expanding stent with a spider fx embolic protection device during treatment of a 30mm plaque lesion in the patient¿s common carotid artery.Artery diameter reported as 6mm.Slight vessel tortuosity and calcification are reported.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).After opening the packaging, it is reported the physician attempted to use a 6x30 stent which the box and packaging was labelled with, however when the device was checked the hub was labelled with 6x40.The device was prepped without issue and used despite the labelling mismatch.The physician assessed the device on x-ray and it looked like a 6x30.No issues noted during the procedure.No patient injury reported.

Manufacturer Narrative

Image review: a single photograph of a cine image was provided for analysis of the implanted protégé rx stent in the patient¿s common carotid artery.Due to the quality and clarity of the image it is not possible to count the individual stent struts rows.Per the initial reported event description the targeted vessel anatomy artery diameter is 6mm.A cropped enlargement of the image was made to aid in analysis.Using the proximal end of the stent, (closest to the heart), as being in full apposition against the vessel walls as being 6mm, the stent is approximately five vessel diameters in length or 30mm in length.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.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.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 11900462
• MDR Text Key: 253132779
• Report Number: 2183870-2021-00197
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038543
• UDI-Public: 00821684038543
• Combination Product (y/n): N
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2023
• Device Model Number: SECX-6-30-135
• Device Catalogue Number: SECX-6-30-135
• Device Lot Number: B140077
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR