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	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the device was received for evaluation loosely packed in a biohazard bag.A portion of the shelf box was included (lot# a769155).Visual inspection revealed the distal portion of the stent was protruding out from the distal end of the catheter outer sheath.Approx.3 mm of the stent was exposed.No damage was noted to the distal tip.The stent diameter and length printed on the strain relief as 10 x 60mm.Functional testing was performed.Annual spaces of the device were flushed and a 0.014¿ guidewire was loaded.Maximum peak force required to deploy stent in the deployment apparatus.The stent was unable to deploy at 3.20 lbs.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a protégé rx during treatment of a lesion in the patient¿s mid common carotid artery.Moderate vessel tortuosity is reported.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.Pre-dilation was performed.The device was not passed through a previously deployed stent.Resistance was reported during advancement.The device was delivered to the target lesion, but it is reported deployment issues were encountered.The physician was hesitant as to whether to continue attempting to deploy the device was there was no sign the tip part would deploy even though it was pulled.The device was removed from the patient, and a different sized protégé rx was used as none of the same size were available to complete procedure.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: 10829301
• Report Number: 2183870-2020-00385
• Device Sequence Number: 19766346
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

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: 01/17/2021
• Device Model Number: SECX-10-60-135
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A769155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1