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

Catalog Number SECX-8-6-40-135

Device Problem Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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of the device to the lesion.It was reported that the stent deformed in vivo during deployment.It was reported to have been replaced by another product.

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.

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
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8752238
• MDR Text Key: 149759573
• Report Number: 2183870-2019-00354
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038703
• UDI-Public: 00821684038703
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 08/06/2019; 09/11/2019
• Supplement Dates FDA Received: 08/07/2019; 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention