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

Catalog Number	SECX-8-6-40-135
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician used a protege rx stent to treat a lesion.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped per ifu without issue.A spider fx was used as embolic protection for the procedure.The device did not pass through a previously deployed stent no resistance was encountered or force was applied during delivery of the device to the lesion.It was reported that the stent deformed in vivo during deployment.It was reported to have been replaced by another product.
Additional Manufacturer Narrative
Additional information: severe stenosis of the carotid artery was being treated.The protege rx could not be deployed.The device was removed from the patient without issue and replaced with another protege rx.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the protégé rx was returned.No ancillary devices or digital media/physician documentation (cd, flash drive, procedure notes ¿ hard copies) were included.The protégé was removed from the packaging and inspected.The tuohy-borst valve was tightened.The stent remained loaded the catheter shaft.Dried blood was noted at the distal rim of the catheter shaft and proximal to the loaded stent.The loaded stent was approximately 4cm.The protégé everflex was unable to be flushed due to encountered resistance while attempting to advance the plunger of the loaded syringe filled with water.A 0.014¿ guidewire from the lab was front loaded successfully.The protégé rx was loaded the deployment apparatus from within the lab.3.22 lbs of force was applied to the deployment grip, but the stent showed no signs of deployment.If information is provided in the future, a supplemental report will be issued.

• 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: 8752238
• Report Number: 2183870-2019-00354
• Device Sequence Number: 1689919
• Product Code: NIM
• UDI-Device Identifier: 00821684038703
• UDI-Public: 00821684038703
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2020
• Device Catalogue Number: SECX-8-6-40-135
• Device Lot Number: A752527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 06/29/2019
• Supplement Date Received by Manufacturer: 08/06/2019; 09/11/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/07/2019; 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention