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 Pain (1994); Rash (2033); Ulceration (2116); Chills (2191); Sweating (2444); Patient Problem/Medical Problem (2688)

Event Date 05/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient had a venaseal carried out on the great saphenous vein(gsv), the short saphenous vein (ssv) and the anterior accessory great saphenous vein(aagsv) on (b)(6) 2019.It was reported that the patient has been returning to the physician between (b)(6) 2019 & (b)(6) 2019 complaining of a number of symptoms including redness and pain; tenderness to left leg; night sweats; chills; edema; maculopapular rash throughout body and spontaneous ulcerations.Treatment prescribed by provider has included voltaren gel; cephalosporin; hctz; clindamycin; furosemide & medrol dose packs.Last reported follow up visit, (b)(6), ultrasound showed closure of veins, still seeing spontaneous formation of wounds with no concerns over open varicosities.Patient was moving to idaho and has been instructed to keep in touch.

Manufacturer Narrative

Image review: images were returned for evaluation.Per the images, the patient access site exhibited multiple ulcers.Images 1 and 2 of the thigh in an area of the gsv exhibit ulceration and healing of the ulceration of the thigh over time.Images 3-5 shows evidence of visible purulent expressible discharge at the access cites of the ssv.Images 6-10 shows progressive healing of the wound over time.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the length of vein treated in each case is reported as right gsv- 75cm, right ssv- 27cm, left gsv- 74cm, left ssv- 26cm.The patient is still in contact with the physician and is taking a heavy steroid with significant symptomatic improvement.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: 8683180
• MDR Text Key: 147471170
• Report Number: 9612164-2019-02260
• 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,Followup
• Report Date: 09/06/2019

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: 06/05/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 06/26/2019; 09/05/2019
• Supplement Dates FDA Received: 07/09/2019; 09/06/2019
• 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): Required Intervention
• Patient Age: 77 YR