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

Catalog Number SEPX-8-6-30-135

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problems Vasoconstriction (2126); Patient Problem/Medical Problem (2688)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was attempting to use a protege rx stent with spider embolic protection to treat a 10 mm plaque lesion in the proximal common carotid artery.The artery was 6-7 mm in diameter and had moderate tortuosity.The lesion was not calcified.The devices were prepped and inspected as per the ifu with no issues identified.The lesion was not pre-dilated.The device did not pass through a previously deployed stent and the physician did not encounter resistance during advancement, no excessive force was used.It was reported that the protege rx stent opened partially and could not be deployed.The physician attempted to retrieve the spider and stent through the guidewire.During retrieval, the spider device was damaged and the vessel went into spasm.The patient was treated with vasodilators and the case was postponed.

Manufacturer Narrative

Device evaluation summary: the protégé rx device was returned for evaluation.The protégé rx stent delivery system was received without a stent.Within its shelf carton, the device was in its transportation tray.No cines or procedure notes were returned for evaluation.The protégé rx was removed from the tray and noted the tuohy-borst valve was loose and could be tightened.The deployment paddle was approximately 95mm from the tuohy borst valve cap.The protégé rx stent delivery system was received without a stent.The retainer was present with no abnormalities observed.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 ; 091708734
• MDR Report Key: 6999712
• MDR Text Key: 90998093
• Report Number: 2183870-2017-00477
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2018
• Device Catalogue Number: SEPX-8-6-30-135
• Device Lot Number: A223206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2016
• 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 Outcome(s): Required Intervention