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

Catalog Number SEPX-8-30-135

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the device returned coiled inside a biohazard pouch.The device was decontaminated with cidex opa solution soak and tergazyme soak.The device was returned with the touhy-borst tight.The device was returned with the stent radiopaque markers and one strut exposed.A 20cc water filled syringe was connected to device and the annual spaces and the guidewire lumen were flushed.A 0.014¿ guidewire was loaded, and the device was loaded into a deployment fixture.The stent was deployed with a maximum peak force of 1.20lbs.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use the protege rx stent during procedure to treat a plaque lesion in the common carotid artery.There was no damage noted to packaging and no issues when removing the device from the hoop/tray.The device was prepped per ifu with no issues.It was reported that the device was unable to deploy.There was no resistance encountered during delivery to lesion.The device did not pass through a previously deployed stent.The thumbscrew was checked for securement prior to procedure.The lock pin was removed prior to surgery.No excessive force was used.No intervention required for removal.No stent struts exposed on removal.Device was safely removed from patient.The procedure was completed with another manufacturer's stent.No patient injury reported.

• 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: 12801829
• MDR Text Key: 282208709
• Report Number: 2183870-2021-00417
• 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
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Catalogue Number: SEPX-8-30-135
• Device Lot Number: B187022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• 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: 56 YR
• Patient Sex: Male