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

Catalog Number	SECX-10-7-40-135
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: while the protégé rx was still within the sealed biohazard pouch, it was noted that the outer sheath of the catheter was pulled back, approximately a 1.4 longitudinal stent struts cells were exposed and flowered.The manifold gap was received tight.A 10cc water filled syringe was attached to the manifold luer lock and the annual spaces of the stent delivery system were flushed with ease.A clear steady stream of fluid was observed exiting the distal end of the outer sheath.A 0.014¿ guidewire was loaded with ease through the distal tip and out the proximal wire port with ease.The locking cap was loosened to allow the deployment.Since the stent was received exposed and flowered the rest of stent was deployed, the rest of the stent deployed with ease.The tapered stent was examined: no abnormality was noted.The distal end of the inner stent delivery system was examined: no abnormality was noted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a protege rx carotid stent system to treat an unknown lesion that appeared to be ¿round¿ in shape.The device was removed from its packaging and inspected prior to use with no issues noted.The lesion was not predilated.The ifu was followed during the procedure and the device was tested prior to use.The lock-pin was checked for securement prior to the procedure.It was reported that as the physician attempted to load the device onto the guidewire, the physician felt resistance and the catheter was stuck on entering the patient.The physician then removed the device from the patient.It was reported that on inspection after removal, approx 3 - 5mm of the stent was already deployed.The physician replaced the device and completed the procedure without further complication.No patient injury was 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: 6887247
• Report Number: 2183870-2017-00419
• Device Sequence Number: 819567
• Product Code: NIM
• UDI-Device Identifier: 00821684038727
• UDI-Public: 00821684038727
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K060001
• 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): 08/24/2017

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: 01/13/2019
• Device Catalogue Number: SECX-10-7-40-135
• Device Lot Number: A400310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1