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

Catalog Number SEPX-8-6-40-135

Device Problems Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician attempted to use a protégé rx stent for patient treatment for the left, mid common carotid artery.It was noted that the plaque lesion had little degree of calcification and moderate degree of tortuosity, with 90% lesion stenosis.A spider 6 mm was used as embolic protection.There was no damage noted to the packaging and there was no issues noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped without issue.It was reported that wire movement issues were noted.Difficulty loading or exchanging the guidewire is reported during advancement through the guide catheter.Device did not pass through previously deployed stent.It is reported the device or component was detached, cracked, fractured or damaged.There was deformation noted on at the tip and the device got kinked while advancing.The lesion was not pre-dilated.No resistance was encountered when advancing the device.Excessive force was used during delivery.One stent strut was exposed in patient.Device was safely removed from patient.The procedure was completed with another device.There was no patient injury reported.

Manufacturer Narrative

Product analysis: the device returned coiled inside its shelf carton.Lot number of carton label: b184019.The device was decontaminated with cidex opa solution soak and tergazyme soak.The protégé rx sds was received with approximately 2mm of the distal end of the stent exposed, and with a kink approximately 19mm from the tip.Image review: the customer returned two images.Image 1 shows a kink in a protégé device.It also appears that the distal end of the stent is exposed.Image 2 shows a protégé device with the distal end of the stent is exposed.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
• 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: 12574737
• MDR Text Key: 274750632
• Report Number: 2183870-2021-00367
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: B184019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• 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 Sex: Male
• Patient Weight: 68 KG