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

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Medwatch report number: mw5081095.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician used the venaseal to treat the great saphenous vein.It was reported the patient¿s body rejected the venaseal glue.Within a week of treatment, the patient was admitted to hospital for an ultrasound due to pain in the right upper thigh.The patient called the doctor a week later and complained that the leg was weak and swollen.The physician prescribed steroids, this did not improve the patients condition a further prescription was given for antibiotics.The patients condition continued to deteriorate developing 9 open sores with shards of glue seeping from the wounds.The patient was admitted for surgery to remove the glue and vein.Concomitant medical treatment was reported as including xanax, zoloft, levothroxine, ropinirole, pantoprazole, flonase and probiotics.

Manufacturer Narrative

This event and the event documented in mw5081096 are the same event.This event was previously reported by medtronic in regulatory report #: 9612164-2018-02666.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: 8149882
• MDR Text Key: 129878587
• Report Number: 9612164-2018-03547
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/11/2018
• Supplement Dates Manufacturer Received: 12/12/2018; 03/08/2019
• Supplement Dates FDA Received: 12/18/2018; 03/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention