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); Death (1802); Dizziness (2194)

Event Date 12/18/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The patient had a successful venaseal procedure on the left great saphenous vein (gsv) followed by sclerotherapy.Compression was carried out manually and with transducer.Post procedure, the common femoral and saphenous at the junction were compressible.Venaseal closure was noted beginning approximately 4cm from the sfj with no clot noted.It was reported that the patient experienced dizziness/ light headedness later the same day of the procedure.Patient was evaluated diagnostically, and it was determined there was a pulmonary embolism located in the left inferior lobar pulmonary artery and right middle lobar pulmonary artery.The patient is currently on lytic therapy and recovery is unknown at this point.

Manufacturer Narrative

The patient presented with heavy bleeding, chest pain and sepsis 3 days prior to the index procedure.Nitroglycerin was administered.Tryponin levels were elevated.Hemoglobin dropped from 10 to 6.The patient experienced a brain bleed/subdural hematoma from the lytic therapy and deceased 2 days post index.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: 8222280
• MDR Text Key: 132231366
• Report Number: 9612164-2019-00084
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• 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: 01/10/2019
• 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; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 72