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

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

Patient Problem Death (1802)

Event Date 05/24/2016

Event Type  Death  

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 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.

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
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: mary haufek ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5591886
• MDR Text Key: 43126930
• Report Number: 3011410703-2016-00009
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death