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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/13/2017

Event Type  Death  

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 patient was enrolled in a physician-sponsored ide investigating valiant thoracoabdominal stent graft system.The subject had a type iii thoracoabdominal aneurysm.As part of this overall investigational clinical treatment, the patient was treated with 4 protégé bare metal stents, 1 valiant (36x100mm), 2 endurant ii limb (16x16x156mm), (16x28x199mm).One thoracic bifurcation (40mm diameter), visceral manifold and 1 non-medtronic device.It was reported the subject passed away approximately 33 days post procedure.The patient collapsed and cpr was administered prior to being transported to er where the patient was pronounced dead.The physician, stated it was likely the patient expired from a fatal cardiac event; however, the exact cause was unable to be determined, the family declined an autopsy.The physician also stated that as he is concerned, the event was not device related.

• 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: 7111853
• MDR Text Key: 94619912
• Report Number: 2183870-2017-00565
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• 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): Death