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 Death (1802); Unspecified Infection (1930); Sepsis (2067)

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient had treatment of the great saphenous vein(gsv) with a venaseal closure system.There was no alleged product issue with the procedure.It was reported that the patient was c6 and had severe reflux in the gsv leading to large varicosities.The physician treated the entire gsv with venaseal as he believed this was his only treatment option for this man as he had past bleeding issues, below knee reflux and superficial state of the gsv and his chf.The physician believed other alternative treatments, such as tumescent anesthesia or stripping would have been a poor choice for the patient, patient denied other treatments as he was very sick and had been for a long period even before the gsv treatment.Several days later the patient was admitted with sepsis and mrsa.Options were given to the patient, which he refused and he subsequently passed away.Dr (b)(6) believed this was procedure related and not device related.

Manufacturer Narrative

The physician treated the entire gsv with venaseal as per ifu using 3cc of glue.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 8654792
• MDR Text Key: 146523945
• Report Number: 9612164-2019-02101
• 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: 09/02/2019

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: 05/02/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 06/08/2019; 08/30/2019
• Supplement Dates FDA Received: 07/01/2019; 09/02/2019
• 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): Death
• Patient Age: 85 YR
• Patient Weight: 78