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	02/28/2019
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 soft tissue, slightly calcified, slightly tortuous lesion in the proximal common carotid artery.The artery diameter and lesion length were reported as 7mm and 30mm, respectively.The lesion was not pre-dilated.There was no damage noted to the packaging and no issues noted when removing the device from the tray.A spiderfx device was used as embolic protection.The device did not pass through a previously deployed stent however, excessive force was applied during delivery of the device to the lesion.It was reported that the stent would not self expand and was deformed on delivery.The procedure was completed using a new stent.There was no patient injury reported.
Additional Manufacturer Narrative
Device evaluation the protégé rx tapered was received with the stent partially exposed out of the outer sheath.Dried blood was observed within the catheter and manifold assembly.The protégé rx tuohy-borst valve was loosened and inserted the device into the deployment apparatus in the lab.The stent was able to be deployed at 2.16 lbs.Which is with the 3lb requirement.Visual inspection of the stent reveal no abnormalities or deformities.The retainer was visible and intact.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: 8386021
• Report Number: 2183870-2019-00107
• Device Sequence Number: 10830264
• Product Code: NIM
• UDI-Device Identifier: 00821684038703
• UDI-Public: 00821684038703
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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,Followup
• Report Date (Section B): 06/26/2019

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: 11/19/2020
• Device Catalogue Number: SECX-8-6-40-135
• Device Lot Number: A743286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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
• Patient Age: 76 YR
• Patient Weight: 69