MAUDE Adverse Event Report: COVIDIEN PROTEGE RX; CAROTID STENT

Model Number SECX-8-6-40-135

Device Problems Sticking (1597); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 11/11/2014

Event Type  Injury  

Event Description

The physician used left cfa access for the left carotid intervention.Embolic protection was placed and the protege rx stent was deployed without issue.After the stent was deployed, the physician was removing the stent deployment system through the sheath and it became stuck in the sheath.After several more times pulling at the stent deployment system it became dislodged from sheath.The doctor removed system out of body and then retrieved the embolic protection device safely out of the body.Investigation of the returned device on 24 november 2014 found not all components of the protege rx were received.The distal outer sheath from the rx port distally was missing.The tip was received detached from the deployment system.

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.

Manufacturer Narrative

This supplemental mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien plymouth location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.

• Brand Name: PROTEGE RX
• Type of Device: CAROTID STENT
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie riley ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 4308282
• MDR Text Key: 5132540
• Report Number: 2183870-2014-00314
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2016
• Device Model Number: SECX-8-6-40-135
• Device Catalogue Number: SECX-8-6-40-135
• Device Lot Number: 9927294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR