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

Model Number SECX-10-7-30-135

Device Problem Premature Activation (1484)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician attempted to treat a lesion in the internal carotid artery with a protege rx stent.The stent pre-deployed during use and was deployed in an unintended target lesion.The physician chose to leave the stent in the vessel and use another product to complete the procedure.It was reported that no patient injury occured.

Manufacturer Narrative

Evaluation summary: the protégé rx deployment system was returned with the tuohy-borst valve loosened and the stent was not included.The finger grip was pushed forward and the inner assembly was exposed.The distal tip and the exposed inner assembly, retainer, and outer assembly were inspected and found not damages or anomalies that would appear to have contributed to the reported event.The finger grip was pulled back and the inner assembly was able to re-enter the outer assembly with no experienced resistance or anomalies.

Manufacturer Narrative

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: 5627545
• MDR Text Key: 44296338
• Report Number: 2183870-2016-00339
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2016
• Device Model Number: SECX-10-7-30-135
• Device Catalogue Number: SECX-10-7-30-135
• Device Lot Number: 9970789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided; 06/28/2016
• Supplement Dates FDA Received: 07/27/2016; 09/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2014
• 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