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

Catalog Number SEPX-8-6-40-135

Device Problems Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

A physician was attempting to implant a protege rx stent in the patients right common carotid artery.Lesion exhibited 87% stenosis.There were no abnormalities reported in relation to anatomy.Physician used an 0.14 guidewire and a 5mm spider fx to reach about 5cm distal to the lesion, and used a 4-30 balloon with standard pressure to dilate.After dilation, physician prepared to implant the protégé rx stent. after opening the outer packaging of the stent, physician fully hydrated it and prepared to go up along the spider guidewire to the location of the lesion.The guidewire slowly entered the stent transporter from the tip end of the transporter, and the stent went upper along the guidewire to the location of the lesion.After all the stents were in place, physician used angiography to confirm the position of the stent again.After confirming the position, physician slowly deployed the stent.The stent was placed smoothly and remains implanted in patient, and the stent transporter was ready to be withdrawn.At the beginning, the withdrawal went smoothly, but suddenly encountered resistance.Physician repeatedly adjusted and rotated the transporter, but still could not withdraw smoothly.When withdrawing the transporter, physician found that the transporter caused the spider to slide down.After adjusting the transporter various angles and directions, it still could not be withdrawn.After trying for about 1 hour and 30 minutes, the surgeon changed the surgical strategy and used a react-71 catheter to go up through the far end of the stent, and withdrew the spider and transporter at the same time.Finally, the spider and transporter were successfully withdrawn, and careful observation found that the tip end of the transporter was broken.The physician determined that after the transporter was damaged, it was entangled with the spider guidewire, causing the transporter to be unable to be withdrawn smoothly.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18985720
• MDR Text Key: 338692119
• Report Number: 2183870-2024-00107
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: B632506
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2024
• Date Device Manufactured: 09/28/2023
• 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
• Treatment: SPIDER FX EMBOLIC PROTECTION SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male