MAUDE Adverse Event Report: SAPHEON / MEDTRONIC VENASEAL CLOSURE SYSTEM-CANADA; AGENT, OCCLUDING, VASCULAR, PERMANENT

Model Number VS-301

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

Patient Problems Pain (1994); Reaction (2414)

Event Date 08/06/2014

Event Type  Injury  

Event Description

The physician successfully completed a bilateral treatment of a patient with the venaseal closure system.At a two day follow up visit, the patient had a small amount of erythema and tenderness on the right leg.The physician gave the patient a pair of 30 - 40 mmhg thigh high stockings and advised the patient to continue ibuprofen to treat these conditions.Three days later, the patient contacted the physician and reported that her left leg was red and sore from the upper thigh down to the knee.She was advised to continue ibuprofen and wear her stockings.There was no swelling in the lower left leg, but had continued left leg tenderness.The patient started to improve 5 days later.The physician assumes superficial phlebitis of the left leg.Patient showed improvement and was placed on prednisone to speed recovery.

Manufacturer Narrative

(b)(4).  a capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.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.

Manufacturer Narrative

(b)(4).

Event Description

This procedure was performed in (b)(6).Customer states that they successfully completed a bilateral treatment of the patient on (b)(6) 2014.At a two day follow up visit on (b)(6) 2014, the patient had a small amount of erythema and tenderness on the right leg.Physician gave the patient a pair of 30 - 40 mmhg thigh high stockings and advised the patient to continue ibuprofen to treat these conditions.On (b)(6) 2014, the patient contacted the physician and reported that her left leg was red and sore from the upper thigh down to the knee.She was advised to continue ibuprofen and wear her stockings.There was no swelling in the lower left leg, but had continued left leg tenderness.The patient started to improve on (b)(6) 2014.Physician assumed superficial phlebitis of the left leg.Patient had a prior history of deep vein thrombosis.Patient also showed improvement and was placed on prednisone on (b)(6) 2014 to speed recovery.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENASEAL CLOSURE SYSTEM-CANADA
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): SAPHEON / MEDTRONIC; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): MORRISVILLE; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: mary haufek ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987070
• MDR Report Key: 4838700
• MDR Text Key: 43768704
• Report Number: 3011410703-2015-00001
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/14/2014

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
• Device Expiration Date: 11/01/2014
• Device Model Number: VS-301
• Device Catalogue Number: VS-301
• Device Lot Number: 34193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 06/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/14/2014
• Supplement Dates FDA Received: 06/11/2015; 03/31/2016; 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2013
• 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; Required Intervention