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

Catalog Number SP-101

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

Patient Problems Edema (1820); Erythema (1840); Inflammation (1932); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician used the venaseal closure system to treat the great saphenous vein (gsv) and the anterior accessory great saphenous vein (aagsv).There were no complications with the procedure.The ifu was followed and the device was prepped without issue.Approximately 1 month post the procedure, the patient returned to the surgery with swelling along the course of the gsv.The patient was treated with antibiotics and heparin.It was reported that it improved except for inside of the knee which remained inflamed.Corticosteroids were prescribed and it was reported that this improved however, the patient has reported the pain and the edema has worsened.

Manufacturer Narrative

Additional information: the patient¿s thigh was treated with the venaseal closure system.The erythema was observed approximately 4 weeks post procedure.Patient first prescribed antibiotics approximately 4 months post-procedure.The patient returned to the surgery with swelling along the course of the great saphenous and anterior accessory vein (gsv).Approx 6 months post index, the patient was operated on for resection of skin, subcutaneous tissue and internal saphenous vein in the area of inflammation.The outcome is favorable.Image review one image was received for evaluation.Per the image, a blistered wound was observed on the patient skin.There is also evidence of redness on the patient wound.The sp-101 venaseal kit was not returned for evaluation.The customer experience of patient allergic reaction post procedure was confirmed based on the image received.One image received from the customer shows a blistered wound and redness was observed on the patient skin.The report indicated the clinical complication occurred post procedure.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: 8559934
• MDR Text Key: 143380286
• Report Number: 9612164-2019-01493
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

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 Expiration Date: 08/31/2019
• Device Catalogue Number: SP-101
• Device Lot Number: 48521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 05/09/2019
• Supplement Dates FDA Received: 05/27/2019
• Date Device Manufactured: 08/21/2017
• 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: 62 YR