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

Catalog Number SEPX-8-6-40-135

Device Problems Premature Activation (1484); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2020

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 along with ev3 embolic protection during procedure to treat a little calcified plaque lesion in the left mid common carotid artery (cca) with 85% stenosis.The lesion length was 31mm.Deployment issues occurred and stent was unable to deploy.There was no resistance encountered during delivery to lesion.The device did not pass through a previously deployed stent.The thumbscrew/lock-pin was checked for securement prior to procedure.It was reported that the stent was delivered normally during the operation, and it was found that the stent could not be deployed after being in place.It was reported that stent struts were visible after deployment attempt.A new stent was successfully used to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Product analysis: the protégé rx was received loosely coiled within a sealed plastic biohazard pouch.No ancillary devices nor procedural images were received for evaluation.The protégé rx stent delivery system, (sds), was visually inspected the outer sheath was received pulled back from the distal tip of the sds.Per the initial reported event description, the ¿stent struts were visible after deployment attempt¿.A 10cc water filled syringe was attached to the y-manifold and the annual spaces were flushed.Sanguine residue was noted in the annual spaces of the sds.The tuohy borst valve was loosened, and the stent deployed with ease; the stent exhibited no abnormality that would affect its ability to be deployed.After deployment, it was noted that the guidewire lumen was wrapped approximately 180 degrees around the pusher wire.The translucent outer sheath was cut to allow examination of the distal assembly.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: 10216615
• MDR Text Key: 197746813
• Report Number: 2183870-2020-00198
• 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: 10/02/2020

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: 09/30/2021
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A907524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Manufacturer Received: 06/28/2020
• Initial Date FDA Received: 07/01/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 75