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

Model Number	SECX-10-60-135
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to manufacturing facility for analysis.The distal portion of the stent was protruding out from the distal end of the catheter outer sheath approximately 2mm.There was damage to tip noted.Evidence of biologic was seen within the catheter and on y-manifold.The device was flushed and a 0.014" guide wire loaded.Maximum peak force required to deploy stent in deployment apparatus to be less that 3lbs and device was unable to deploy.The inner shaft (proximal grip) exhibited a bend at 3.53lbs.There was no damage noted to the inner distal assembly.There was no damage to the stent condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to treat the mid carotid artery using protege stent.The sheath was so hard that the protege which was delivered but could not be deployed.A new product with the same size was used without issues and the procedure was completed without any issues.There was no patient injury reported.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9680510
• Report Number: 2183870-2020-00041
• Device Sequence Number: 11616484
• Product Code: NIM
• UDI-Device Identifier: 00821684038680
• UDI-Public: 00821684038680
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: SECX-10-60-135
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A642696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1