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	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The distal portion of the stent was protruding out from the distal end of the catheter outer sheath approximately 2mm.A serpentine coiling of the outer assembly was noted 124 ¿ 128 cm from the distal tip.Maximum peak force was required to deploy stent in the deployment apparatus.The inner shaft (proximal grip) exhibited a bend at 2.26 lbs.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use a protege rx carotid stent during treatment of a lesion in the patient¿s mid common carotid artery.There was no calcification.Vessel tortuosity is reported.No damage noted to packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed.The device was prepped without issue.The thumbscrew/lock-pin was checked for securement prior to procedure.Pre-dilation was performed.The device was not passed through a previously deployed stent.No resistance was encountered during advancement of the device.It is reported that the stent was unable to be deployed.The device safely removed from the patient and was replaced with a non-medtronic carotid device.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: 9648190
• Report Number: 2183870-2020-00031
• Device Sequence Number: 2767816
• 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): 01/30/2020

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: 10/15/2020
• Device Model Number: SECX-10-60-135
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A724326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1