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

Catalog Number SEPX-8-6-40-135

Device Problems Difficult to Insert (1316); Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the device returned coiled in a biohazard bag.Device was decontaminated with cidex opa solution soak and tergazyme soak.The device was returned with the lock pin tight.The device was returned with distal end of the stent exposed.A visual inspection of the device found pinch/damage to the outer at the stent retainer.A 20cc water filled syringe was used to flush the inner lumen and the annual spaces.A 0.014¿ guidewire was loaded through the tip but would only load as far as the stent retainer.The lock pin was loosened, and the stent was deployed without difficulty.A visual inspection of the exposed distal section of the inner lumen found stretching pinching/damage to the stent retainer.Image review: three photographic images were received for review.The first image is of the distal end of the protégé rx stent delivery system.The outer sheath of the catheter is pulled proximally from the distal tip, but the stent is not exposed or flowered.Due to the quality and clarity of the image it is not possible to identify any abnormality or deformity to the stent delivery system guidewire lumen.The second image is of the proximal end of the stent delivery system.The deployment paddle is distal of the touhy borst valve of the stent delivery system.The third image is of the protégé rx stent delivery system shelf carton.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician attempted to use a protégé rxs tent to treat a calcified lesion of moderate of tortuosity in the proximal common carotid artery.Lesion stenosis was 75%.There were no abnormalities reported in relation to anatomy.A spiderfx 5mm was used for embolic protection used.No damage was noted to packaging (i.E.Shelf carton, hoop/tray).No issues noted when removing the device from the hoop/tray.The device was prepped per the ifu, with no issues identified.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.No excessive force.Wire movement issues were reported.There were difficulties loading or exchanging guidewire.The device was safely removed rom the patient and was replaced with the same type of stent and the procedure completed.There were no patient symptoms or complications associated with this event.The device was returned with distal end of the stent exposed.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 12428211
• MDR Text Key: 283097843
• Report Number: 2183870-2021-00319
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A974246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR