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

Catalog Number	SECX-10-60-135
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	05/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was using a protégé rx carotid stent system with a non-medtronic guidewire, non-medtronic 8f guide catheter and non-medtronic 8f sheath for treatment of a 50mm lesion which had a medium level of calcification in the internal carotid artery and common carotid artery.The lesion exhibited 90% stenosis.The device was prepped as per the ifu without issue.There was no unusual resistance noted when the protective sheath was removed.The lesion was not pre-dilated.There was no resistance encountered when passing the lesion.Upon removal of the ez filter after post-dilation the catheter of the filter got caught by the strand of the protégé stent strut.The physician repeatedly pushed and pulled the filter and also stretched the patient¿s neck and applied pressure to remove the catheter.The filter and catheter were removed from the patient successfully.The physician later took a ct image and noticed that the protégé was deformed inward.Intervention procedure was carried out on (b)(6) to fix the deformation using a balloon.Patient¿s current status is reported as fine with no adverse issue reported.The stent was implanted during this procedure.
Additional Manufacturer Narrative
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: 6659390
• Report Number: 2183870-2017-00270
• Device Sequence Number: 1539150
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2017

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: 10/25/2017
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A178662
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: 82 YR