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

Catalog Number SEPX-7-40-135

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/19/2017

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 carotid stent to treat a plaque and soft tissue lesion with little calcification in the proximal common carotid artery.The lesion was 40 mm in length and resulted in 95% stenosis in the vessel.The artery had a diameter of 5 mm and had little tortuosity.The procedure used a non-medtronic 6fr sheath and a non-medtronic guidewire.Spider embolic protection was used.No damage was noted to the packaging or the device.The lesion was pre-dilated using 3 mm and 5 mm pre-dilation devices.During prep according to the ifu the device was flushed.It was reported that the guidewire could not cross the delivery system of the stent.The patient suffered from angiospasm and the symptoms were relieved after being administered papaverine, a vasodilator medication.The procedure was completed using an 8-6/40 stent without further complications.No patient injury was 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 ; 091708734
• MDR Report Key: 7041618
• MDR Text Key: 92335891
• Report Number: 2183870-2017-00512
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2019
• Device Catalogue Number: SEPX-7-40-135
• Device Lot Number: A460039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/17/2017
• Date Device Manufactured: 05/15/2017
• 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: 63 YR