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

Catalog Number SEPX-10-7-40-135

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician was attempting to use one protege rx device to treat a slightly tortuous and slightly calcified lesion located in the proximal carotid artery, exhibiting 90% stenosis (6.3 x 8 mm).A spider device was used as embolic protection.The device was removed from its packaging and inspected with no issues noted.The lesion was pre-dilated using an unknown balloon catheter.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.It was reported that the protégé rx catheter ¿bunched¿ during attempted positioning.The spider catheter was also involved in the bunching.The physician removed the device without difficulty and used another device to complete the procedure.No damage was noted to the stent on removal.No patient injury was reported.

Manufacturer Narrative

Device evaluation summary: the protégé rx was returned for analysis.The protégé rx was inspected and noted the stent was deployed and not included with the returned contents.The tuohy-borst valve was tightened.Approximately 2cm of the inner was exposed outside of the blue outer.A bumped/bent outer was discovered approximately 11 cm from the distal rim of out outer.A 0.014" guidewire from the lab was attempted to be front-loaded; however the guidewire was blocked from advancing approximately 18cm from the distal tip.The area of the blockage was viewed under microscope, but could visualize the guidewire tubing beneath the blue outer.The inner showed a serpentine bend at the location of the inability to load the guidewire.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: 7042638
• MDR Text Key: 93095214
• Report Number: 2183870-2017-00513
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2018
• Device Catalogue Number: SEPX-10-7-40-135
• Device Lot Number: A371482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• 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 Age: 76 YR