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

Catalog Number SEPX-9-30-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a protege rx self-expanding stent during procedure to treat a moderately calcified plaque lesion in the common carotid artery.There was no damage to device packaging.There was no issue noted when removed device from hoop/tray.The device was prepped per ifu with no issues identified.It was reported that the stent could be deployed from the sheath.Stent struts were partially exposed outside the sheath within the patient's vessel.The device was removed from the patient without difficulty.Physician used another manufacturer's product to complete the procedure.No vessel damage reported.There was no patient injury reported.

Manufacturer Narrative

Image review a photo of the reported issue was received for evaluation from the customer.It was observed that the protégé rx device had the distal portion of the stent protruding out from the distal end of the catheter outer sheath.The device was loosely packed inside a biohazard pouch.The lot number written on the biohazard pouch was consistent with the reported device.Stent diameter and length printed on strain relief was 9x30 mm.Mpxr and fedex documentation were displayed.Device evaluation the protégé rx was returned for evaluation loosely packed inside a biohazard pouch.No device identification (product labeling) was included.No ancillary devices from the procedure were received for evaluation.The device was removed from the packaging and visually inspected.The device was returned in a post deployed state.The inner assembly was exposed outside the distal rim of the catheter outer and the deployment grip was advanced forward.The stent received had a length of approximately 30 mm.No abnormality or deformity was noted with the returned stent.No damage to the retainer or distal tip was noted.The device strain relief indicated that the stent diameter and length were 9 x 30 mm, consistent with the reported device.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: 10571981
• MDR Text Key: 208115387
• Report Number: 2183870-2020-00304
• 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: 11/04/2020

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: 04/17/2021
• Device Catalogue Number: SEPX-9-30-135
• Device Lot Number: A817066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR