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 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the device returned loosely coiled in a biohazard bag within a zip lock bag.No procedural images were received for evaluation.Device was decontaminated with cidex opa solution soak and tergazyme soak.The protégé rx sds was received with the stent partially deployed and with a bend on the pushrod.The bending found on the device may have occurred during shipping of the device to the lab.The device was returned with bunching/damage approximately 20 mm and kink approximately 55mm.From strain relief.During functional testing the stent could not be deployed due to the condition of the returned device.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a protégé rx carotid stent system with a spider fx embolic protection device with a non-medtronic 8fr sheath during treatment of a 30mm calcified lesion in the patient¿s mid common carotid artery.Moderate vessel calcification and tortuosity are reported.Lesion exhibited 90% stenosis.Artery diameter reported as 6mm.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.The thumbscrew/lock-pin was checked for securement prior to procedure.Pre-dilation was not performed.The device was not passed through a previously deployed stent.Resistance was encountered during delivery to the lesion and excessive force was used.The lock-pin was removed when entering the patient¿s vasculature entering the sheath.Deployment issues are reported.The physician advanced the device to the lesion and when attempting to deploy noted that the delivery rod was withdrawn, and resistance was felt.Two unsuccessful attempts were made to deploy the stent.The physician was concerned any further attempts would affect the blood vessels and removed the device from the patient and replaced with a device of the same size and model to complete the procedure successf ully.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: 11927855
• MDR Text Key: 254087780
• Report Number: 2183870-2021-00201
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A939861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• 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 Age: 67 YR