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

Model Number SECX-8-6-40-135

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Perforation of Vessels (2135)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.(b)(4).

Event Description

The procedure was to be performed on the carotid artery, however the protege rx ended up partially deploying the proximal common iliac artery.The target lesion had little tortuosity or calcification.Embolic protection was being used.The tumbscrew/lock-pin was checked prior to the procedure.The protege rx was prepped with no issues identified.Per the initial report, the stent was not passed through a previously deployed stent, but there was excessive force needed during delivery.During deployment severe resistance was felt and upon pull back the stent partially deployed 40mm in the patient's common iliac.Half of the stent was deployed in the femoral artery.The vascular surgery was called in to perform a cut down to remove the stent.There was reported vessel perforation and access site bleeding.The femoral cut-down was performed by the surgeon, the stent was removed and the artery repaired.Evaluation of the returned protege rx noted that the device was received in a plastic container.Only the stent was received.The received stent showed biological material throughout most of the stent, and there was no evidence of fracture or missing struts.The stent exhibited 5mm elongation.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane n; plymouth MN 55442
• Manufacturer Contact: mary haufek ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5213307
• MDR Text Key: 30854823
• Report Number: 2183870-2015-07537
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2017
• Device Model Number: SECX-8-6-40-135
• Device Catalogue Number: SECX-8-6-40-135
• Device Lot Number: A115953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• 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): Required Intervention
• Patient Age: 00071 YR
• Patient Weight: 91