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 Pulmonary Embolism (1498); Phlebitis (2004); Pneumonia (2011)

Event Date 04/26/2018

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 treated 22mm of the patient¿s great saphenous vein (gsv) with venaseal.The catheter was placed 7cm from the sfj and extra glue was given.Compression was applied to the gsv and the vein successfully closed.Aspirin (asa) was prescribed post procedure.Five days post procedure the patient presented with phlebitis.Eight days post procedure the patient returned to the immediate care center with a cough and shortness of breath and was prescribed levocin to treat pneumonia.Fourteen days post-procedure it was reported that the patient tested positive for pulmonary embolism (pe) in the right lower lobe during a hospital visit and was prescribed heparin and warfarin.Six days post identification of the pe, the patient tested negative and there was no evidence of deep vein thrombosis (dvt).The physician reported that the stump was good initially but believes that the stump may have had blood pool which created a thrombus that broke off causing the pe.

• 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: 7539858
• MDR Text Key: 109095108
• Report Number: 9612164-2018-01210
• 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
• Report Date: 05/24/2018

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: 04/26/2018
• Initial Date FDA Received: 05/24/2018
• 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