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

Catalog Number VS-402

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Reaction (2414)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

One image was received showing redness in multiple areas of patient¿s leg and buttocks.The venaseal device was not returned for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient received treatment of their short saphenous vein (ssv) with venaseal.Patient returned for follow-up ultrasound one-week post-implantation and presented with an itching feeling.It was unknown if this was due to venaseal treatment or other cause, no other physical symptoms reported.4 days post the follow-up visit patient called physician.An extreme skin rash and delayed extreme allergic reaction reported.Patient was treated with a medrol pack and anti-inflammatories.It is reported the rash/allergic reaction is still present.Follow-up with the physician indicates the patient is doing much better.Following the steroid perscription the patient has a minimal rash remaining.Patient will continue treatment for a month and will then be referred to an allergist.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7955642
• MDR Text Key: 123372991
• Report Number: 9612164-2018-02713
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 51131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2018
• Date Device Manufactured: 04/19/2018
• 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): Required Intervention