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

Catalog Number SEPX-10-7-40-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

Image review four images were received for evaluation.Image 1 shows the device shelf box indicating the device was protege rx tapered.Images 2 shows the device was in its inner label pouch within the transportation hoop.Images 3 and 4 show evidence of the blue outer sheath pull back and stent was exposed.Based on the image quality, the stent does not appear to be damaged.It is unknown if the tough borst was tight.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a protege rx self-expanding stent with a spider fx embolic protection device during treatment of a plaqued lesion in the patient¿s mid common carotid artery.Moderate vessel calcification and tortuosity are reported.No damage noted to packaging prior to use nor issues 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.No resistance was encountered during advancement of the device.The device was not passed through a previously deployed stent.It is reported deployment difficulties were encountered.The lock-pin as removed when the stent was placed prior to attempted deployment.The stent could not be deployed.The device was safely removed from the patient and replaced with a competitor device to complete the procedure.Photos of the device were received for evaluation, and it was noted that the stent was partially deployed.

• 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 ; IE ; 091708734
• MDR Report Key: 9915103
• MDR Text Key: 194541946
• Report Number: 2183870-2020-00096
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051379
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2020
• Device Catalogue Number: SEPX-10-7-40-135
• Device Lot Number: A596276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2020
• Date Device Manufactured: 02/12/2018
• 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