MAUDE Adverse Event Report: COVIDIEN PROTEGE RX; STENT CAROTID

Model Number SEPX-7-40-135

Device Problems Component or Accessory Incompatibility (2897); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2014

Event Type  malfunction  

Manufacturer Narrative

This 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.(b)(4) (b)(6).

Event Description

The physician was intending to use a (b)(4); rx for treatment of the right internal carotid artery.During positioning it was reported that the physician felt resistance went moving the sds backward and forward on the protective umbrella wire.The stent was withdrawn and the stent was noted to be partially deployed upon removal.The procedure was successfully completed with an unknown stent.There was no patient injury or intervention required.Evaluation summary: the protege rx stent delivery system (sds) was received for evaluation with 2 1/2 stent cells exposed.The stent was normal in appearance.The manifold (hemostasis) cap was attached but the o-ring was not compressed on the hypotube.The cap appeared tilted.A test 0.014" guidewire was loaded through the guidewire lumen without complication.The device was loaded into the deployment force test fixture.The stent was deployed with 1.38lbs of force "deployment resistance" was typical for a dry-deploy.

• Brand Name: PROTEGE RX
• 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: mary haufek ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5139855
• MDR Text Key: 28259364
• Report Number: 2183870-2015-00381
• 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
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2015
• Device Model Number: SEPX-7-40-135
• Device Catalogue Number: SEPX-7-40-135
• Device Lot Number: 9836667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2013
• 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