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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problem Reaction (2414)

Event Date 02/16/2020

Event Type  Injury  

Manufacturer Narrative

Image review: three photographic images of the patient¿s treated right leg were provided for review.The first image is of patchy erythema on the patient¿s leg.Due to the lack of physical landmarks it is not possible to determine where on the leg the erythema is located.The second image is of the patient¿s treated right leg in the area of the knee.There is some erythema over the treated vessel on the patient¿s thigh and upper calf.There appears to be three access site wounds on the lower right calf that exhibit erythema.The third image is of the patient¿s treated right leg lower calf.Three access sites wounds with erythema are present.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient received treatment with venaseal and the great saphenous vein (gsv) was treated.It was reported that 2 weeks after treatment, a hypersensitivity reaction was noted and a medrol pack was prescribed.A second follow up visit was carried out approximately 4 weeks after the procedure and some improvement was seen since last visit, but inflammation was still present.A second dose of medrol pack was prescribed.The patient had another follow up consultation 8 days later and further improvement was noted with very little inflammation present.The patient is scheduled another procedure in the future.No further patient injury was reported.

Manufacturer Narrative

Image review: three photographic images of the patient¿s treated right leg were provided to medtronic investigation lab for analysis.The first image is of patchy erythema on the patient¿s leg.Due to the lack of physical landmarks it is not possible to determine where on the leg the erythema is located.The second image is of the patient¿s treated right leg in the area of the knee.There is some erythema over the treated vessel on the patient¿s thigh and upper calf.There appears to be three access site wounds on the lower right calf that exhibit erythema.The third image is of the patient¿s treated right leg lower calf.Three access sites wounds with erythema are present.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: 10223258
• MDR Text Key: 197273763
• Report Number: 9612164-2020-02393
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• 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
• Date Manufacturer Received: 07/08/2020
• 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: 65 YR