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

Catalog Number VS-402

Device Problem Off-Label Use (1494)

Patient Problems Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

No components from the venaseal closure system kit or sonographic images were received for evaluation.Five photographic images on five consecutive off-visits of the patient¿s symptoms were received for evaluation.The images are of the patient¿s right lower limb just above the medial malleolus.On (b)(6) 2018 a pinkish pimple is observed just above the medial malleolus.On (b)(6) 2018 swelling and expanded area of redness is noted in the area just above the medial malleolus.On (b)(6) 2018 the skin appears to have hardened, the coloration has darkened, and the skin is beginning to peel.On (b)(6) 2018 the swelling has receded, the skin appears rough, and a black crust on a superficial sore has formed.On (b)(6) 2018 the area of redness has reduced in size, the skin in the vicinity of the superficial sore is rough, and the black crust on the sore has thickened.On (b)(6) 2018 the swelling continues to recede and the black crust on superficial sore remains.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a patient was treated off label with vena seal (vs) adhesive only in the ankle perforator vein, near the medial malleolus.The patient developed a very small thrombus in the untreated segment of the gsv approx 3+ inches from the perforator treatment zone.This then developed into a necrotic erosive lesion.The nurse practioner does not believe it is associated with the vs treatment, but is most likely the result of a spider bite.There was no venaseal adhesive in or near the lesion.No further patient complications have been reported as a result of this event.Patient is receiving conservative wound treatment and will be monitored.

Manufacturer Narrative

Implant date reported (b)(6) 2018 is incorrect.Date of impant is not known.Additional information received: patient was referred to a wound care md after (b)(6) 2018.Physician is confident the wound was from a spider bite, possibly brown recluse.No further information available.If information is provided in the future, a supplemental report will be issued.

• 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: 8105188
• MDR Text Key: 128385677
• Report Number: 9612164-2018-03359
• 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,Followup
• Report Date: 01/08/2019

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 Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 01/08/2019
• 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