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 Foreign Body Reaction (1868); Patient Problem/Medical Problem (2688)

Event Date 12/18/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal closure system to treat 45cm of the great saphenous vein (gsv).The ifu was followed during preparation, procedure and post-procedure.It was reported treatment was completed without issue.Some months post procedure, patient developed two lesions at the surface of the skin.The cast of the glue was removed from one of the lesions.Patient is stable and lesions are reported as smaller and better.

Manufacturer Narrative

Additional information: patient is doing well and lesions are progressing.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Patient presented with symptoms approximately 3 months post procedure and was prescribed topical cream two days post onset of symptoms.The cast of glue was extruded through the first lesion.The second lesion will not require any treatment.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: four photographic images were received of the patient symptoms from three office visits.Image one is from approximately 6 months post-procedure and shows three lesions of the patient¿s treated leg along with redness on the backside of the leg.The middle lesion shows a collection of purulent along the rim of the lesion.Image 2 is from approximately 9 months post-procedure and shows three lesions of the patient¿s treated leg.The lesions show healing progressing and smaller amount of purulent along the rim of the middle lesion.Images 3 and 4 are from 10 months post procedure.Image 3 show three lesions of the patient¿s treated leg.The lesions are darker than the surrounding skin.Image 4 is of an adhesive cast excised from the patient¿s leg from one of the lesions.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: 8873311
• MDR Text Key: 153652268
• Report Number: 9612164-2019-03277
• 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,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• 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
• Date Manufacturer Received: 10/29/2019
• 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: 77 YR