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

Catalog Number SEPX-8-6-40-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a protege rx stent with a non-medtronic 8f sheath, 0.014 non-medtronic guidewire and spider fx embolic protection device during treatment of a 33mm calcified and plaque lesion in the patient¿s mid right common carotid artery of diameter 7.5mm.Severe vessel tortuosity and moderate calcification are reported.Lesion exhibited 90% stenosis.No damage was noted to packaging prior to use.No issues were noted when removing the device from the product packaging.Ifu was followed and the device was prepped without issue.The thumbscrew/lock-pin was checked for securement prior to procedure.Pre-dilation was performed using a 3.5mm balloon.Deployment issues are reported.No resistance was noted during delivery to the lesion and the device was not passed through a previously deployed stent.The lock-pin was removed prior to attempted deployment.The stent could not be deployed.It was reported that 3mm of the stent was exposed outside the sheath during deployment attempt.The device was safely removed and replaced with another protégé rx stent to complete the procedure.No vessel damage was noted.The physician was able to deploy the stent outside the patient using unusual force.No patient injury reported.

Manufacturer Narrative

Image review four images were returned for review.Photographs 1 and 2 contained the device packaging.The first photograph contained the protégé rx device within the opened sterile label pouch and transport tray.The sterile label pouch had been opened.No anomalies or damages were observed with the device or the packaging.The second image contained the label portion of the shelf-box.The label on the open sterile label pouch could not be determined; however, the shelf-box indicated lot number a954932, inconsistent with the reported lot number.Within the 3rd image, the pusher of the device was extended past the distal tip of the blue catheter shaft.The stent had been previously deployed from the device.A red blood-like substance was noted on the device in the image.The 4th image contained the deployed stent, the blue catheter was not included in the image.No damage to the stent was observed in the photograph.Device evaluation the device was removed from the return packaging.The device was received in a post-deployment state.The stent was not returned for review.A red, blood-like substance was observed within the returned device.No anomalies with the catheter shaft.Microscopic inspection: no damage or anomalies were observed with the retainer legs (photo 7).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 10611460
• MDR Text Key: 209349584
• Report Number: 2183870-2020-00311
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A753866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR