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

Model Number SECX-8-6-40-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: the protégé rx was retuned for analysis.No ancillary devices were returned.The protégé rx was visually inspected - approximately 3mm of the stent was deployed outside of the outer assembly.The tuohy borst valve cap was loose.The distal tip bent/curved.No damages were noted to the stent which was exposed outside the outer assembly or within the catheter.Dried blood/biological debris was noted within the catheter.The protégé rx was attempted to be front-loaded; however resistance was encountered.The catheter was then attempted to be flushed with water administered by a 10ml syringe, however resistance was encountered.Blood backed up within the manifold assembly while attempting to deploy in the deployment apparatus.A 2.86 lbs force was applied and the stent was able to advance outside of the distal assembly.The total length of the stent exposed from the catheter was approximately 2cm.The outer assembly of catheter was skived.The biological material adhered to the inner assembly and the inner lumen of the outer assembly.The proximal end of the catheter where the outer was skived could not advance the inner assembly due to resistance.The distal end of the catheter which was skived was able to advance the inner assembly with minimal resistance.Analysis summary/results: the stent could not be deployed until the outer assembly was skived and the inner was pushed forward at the distal end of the catheter.Less interference with the biologics discovered within the catheter at the distal end compared to the proximal end.

Event Description

Physician was attempting to use a protégé rx stent on a lesion in the carotid artery.It was reported that the stent did not deploy when the physician pulled the outer sheath.Strong resistance was felt while pulling the outer sheath.A new protégé rx stent was used to complete the procedure.No injury to patient was reported.

Manufacturer Narrative

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: 6492043
• MDR Text Key: 72806044
• Report Number: 2183870-2017-00168
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038703
• UDI-Public: 00821684038703
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2018
• Device Model Number: SECX-8-6-40-135
• Device Catalogue Number: SECX-8-6-40-135
• Device Lot Number: A314204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• 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