MAUDE Adverse Event Report: COVIDIEN VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/24/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
The date of the reported death is not known.The information received indicates (b)(6) 2016.Additional information was requested on this event, but was not available.Should it become available a supplemental report will be submitted.
Event or Problem Description
The complaint information was received after review of a private social media group, which includes 1713 vascular and interventional surgeons in (b)(6).The information reported within the group indicates that there were 2 deaths associated to the venaseal within the us in (b)(6) 2016.No other information of these reported events are available.
Additional Manufacturer Narrative
Investigation results: medtronic was unable to track the social media posting to an original source or individual through its investigation.The reported deaths have not been confirmed, and it is also unknown if they were caused by or related to the venaseal closure system.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Common Device Name: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• MDR Report Key: 5591886
• Report Number: 3011410703-2016-00009
• Device Sequence Number: 372318
• Product Code: PJQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2016

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2016
• Supplement Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death