MAUDE Adverse Event Report: COVIDIEN PROTEGE RX; CAROTID STENT

Model Number SECX-10-60-135

Device Problems Break (1069); Difficult to Remove (1528); Device-Device Incompatibility (2919)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 08/13/2014

Event Type  Injury  

Event Description

This carotid artery stenting procedure was performed in (b)(6).During the procedure on the carotid artery, the physician felt the spiderfx delivery catheter was caught by the protégé rx stent upon removing from the patient.The filter of the spiderfx became caught by the stent, and the physician could not retrieve the spider filter from the patient.Therefore, the physician used a different delivery catheter (4fr angiographic catheter) to retrieve the spider filter from the patient.The filter was removed from the patient successfully.However, the protégé rx stent partially broke.The physician also noted the stent deployed inside the patient looked like a heart shape.The physician determined no additional approach to the lesion was possible.Please reference mdr 2183870-2015-00015 for the spiderfx used in this procedure.

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 (b)(4) 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: 4430919
• MDR Text Key: 5419625
• Report Number: 2183870-2015-00014
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2016
• Device Model Number: SECX-10-60-135
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: 9816125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2013
• 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): Other