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

Catalog Number SEPX-8-6-40-135

Device Problems Obstruction of Flow (2423); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems Embolism (1829); Thrombus (2101)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician used a protege rx device for treatment of a lesion in the patient¿s common carotid artery.The ifu was followed and the device was prepped without issue.The lesion was not pre-dilated.It was reported that the device did pass through a previously deployed stent and resistance was encountered during advancement.No excessive force was used.It was reported catheter deformation occurred which was described as stretching.It was reported the catheter was occluded.It was also reported that the device was unable to cross.It was reported that a non-medtronic 0.014¿ device was used to complete the procedure.Embolism and thrombus were reported outcomes for the patient.

Manufacturer Narrative

Additional information: the lesion was described as an occlusive calcification lesion.After attempting to pass the guide nitrex 0.014 through the protege rx stent delivery system, it was found to be occluded, making it impossible to use.The device was not deployed.Another device was implanted without difficulty.The patient is reported to be doing well.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

The protégé rx carotid stent system was received for evaluation within a large plastic zippered closure pouch and loaded in the protective transportation hoop of a pta device.No ancillary devices were received for evaluation.The protégé stent delivery system, (sds), was received with the tuohy borst valve tight, no kinks or defects were noted along the length of the outer shaft, the stent was fully enclosed within the outer shaft, and the sds distal tip was in proper contact with the distal end of the outer sheath.The distal end of the sds was placed in a bath of water and a 10cc water filled syringe with a blunt tip needle was used to flush the guidewire lumen of the sds: a clear steady stream was observed leaving the distal tip.A 10cc water filled syringe was attached to the manifold luer lock hub and the annual spaces of the sds were flushed.A 0.014¿ guidewire was loaded through the distal tip but would not navigate its way out the proximal wire port.Examination of the sds with the aid of magnification revealed that the inner guidewire lumen was wrapped around the pusher wire.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
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7690362
• MDR Text Key: 114068486
• Report Number: 2183870-2018-00382
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2019
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A396459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2017
• 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
• Patient Age: 64 YR
• Patient Weight: 113