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

Catalog Number	SECX-10-7-40-135
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use two protégé rx devices and a spider fx device during treatment of a calcified cto (chronic total occlusion-100%) in the patient¿s mid left common carotid artery.Severe calcification and tortuosity are reported.Ifu was followed and the devices were prepped without issue.It is reported that resistance was encountered when advancing both protégé rx devices and excessive force was required during delivery.It is reported that the stent wire snapped and the stent could not be deployed.The procedure was completed using a competitor stent.No patient injury.
Additional Manufacturer Narrative
Additional information: the device was removed through the sheath without any intervention required.Evaluation summary: the protégé rx unit was returned.No ancillary devices were included.The protégé rx was inspected and the distal end of the stent was found to be flowered out from the distal rim of the blue outer.The tuohy-borst valve was tightened.The distal tip and guidewire lumen were exposed outside from the distal tip of the catheter about 0.5cm.A bend to the catheter was observed at approximately 21 cm from the distal tip.No damage to the stent was observed.A guidewire from the lab was attempted to be loaded; however the lumen was occluded so the guidewire could not pass.The protégé rx was inserted into the lab deployment apparatus.After loosening the tuohy-borst valve the stent would not deploy at 2.58 lbs.The hypotube between the tuohy-borst valve and deployment grip showed bending while pressure was applied.The catheter was removed from the deployment apparatus and attempts to push the deployment grip were carried out.The deployment grip, advanced against resistance, was able to deploy the stent.No damage to the stent was observed.Within the blue catheter inner diameter, traces of dried blood was noted.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: 8094117
• Report Number: 2183870-2018-00516
• Device Sequence Number: 11259463
• Product Code: NIM
• UDI-Device Identifier: 00821684038727
• UDI-Public: 00821684038727
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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: 11/06/2019
• Device Catalogue Number: SECX-10-7-40-135
• Device Lot Number: A551663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1