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

Catalog Number SEPX-8-6-40-135

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported that an attempt was made to use a  protege rx self expanding stent to treat a calcified fibrous plaque lesion in the mid carotid artery - common. degree of tortuosity was little. degree of calcification was little.Lesion stenosis was 90%.A spider6mm for embolic protection was used.Device prepped per the ifu.Lesion was pre-dilated with a 4*30mm pre-dilation device.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.Partial deployment occurred.There was no damage to the deployment mechanisms or device handle prior to deployment issue.Thumbscrew/lock-pin was checked for securement prior to procedure.Lock-pin was not removed.No intervention was required for removal of the device and was safely removed from the patient.Procedure completed by using another stent of the same model. no patient injury reported.

Manufacturer Narrative

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.

Manufacturer Narrative

Product analysis: the device was returned with the touhy-borst loosened.The stent confirmed as 40mm.The device was returned with approx.10mm of stent exposed.A kink was noted on the device at approx.12.5cm from the distal tip.The device was observed to have dried biologics in the lumen of the blue outer sheath and around the exposed stent area.A 20cc water filled syringe was used to flush the device, the device flushed by guidewire space only.A 0.014¿ guidewire was loaded through the guidewire lumen and advanced the entire length and exited the guidewire port.The device was loaded into a deployment fixture.The stent could not be deployed with a maximum peak force of 7.90lbs.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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17824662
• MDR Text Key: 324352382
• Report Number: 2183870-2023-00358
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: B442102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Date Device Manufactured: 09/06/2022
• 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: 76 YR
• Patient Sex: Male