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

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problem Thrombosis (2100)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a venaseal kit to treat the patient¿s left small saphenous vein (ssv).The ssv was punctured from the ankle using the catheter and was completed the desired treatment without problems.No deviations related to the location of the catheter tip prior to the initial delivery of adhesive were noted.6cm of the patient's left ssv was treated using 4 aliquots of adhesive.Postoperative dus confirmed that both feet had no patency.The patient returned for follow-up 7 days post procedure and it was confirmed that there were no adverse events, device malfunctions and no patency of the treated vein by dus.The patient returned for follow-up 1 month post index procedure, and it was confirmed that there were no adverse events, device malfunctions and no patency of the treated vein by dus.The patient returned for a scheduled follow-up 3 months post index procedure and thrombophlebitis was identified in a branched varicose vein from an blocked small saphenous vein.The patient was diagnosed with superficial venous thrombosis described as epigenetic venous thrombosis.The patient was prescribed acetaminophen orally for about a week and advised to rest, which resulted in improvement of symptoms.The physician commented that the causal relationship with this product was unknown and the causal relationship with the procedure was unknown because the thrombophlebitis was on a branch varicose vein from the blocked small saphenous vein, and confirmed that here was no patency of the treatment vein by dus.The physician judged the event as being non-serious.The patient is reported to have recovered.No further injury reported.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10395271
• MDR Text Key: 202518602
• Report Number: 9612164-2020-02968
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 08/12/2020

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: 07/31/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 56194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/12/2020
• Date Device Manufactured: 07/04/2019
• 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: 44 YR
• Patient Weight: 83