MAUDE Adverse Event Report: MEDTRONIC INC., 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 Itching Sensation (1943); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 04/18/2019

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 patient had treatment of the great saphenous vein (gsv) with a venaseal closure system.The ifu was followed during preparation, procedure and post procedure.No tumescent infiltration was used.Local anesthesia was used.The procedure was completed without incident.There was no alleged product issue.Post the procedure, the patient reports an allergic response of discomfort, itching and pain.The physician has prescribed steroids.

Manufacturer Narrative

Additional information: the area treated was the left gsv to the mid-calf.No compression was applied following procedure.Follow-up scan was carried out 3 days post-procedure without any issues identified.Initial reaction was reported as occurring 17 days post the procedure.The patient visited the er for leg swelling and itchiness behind knee.Red streaks were present, and leg described as being warm to touch.Negative for dvt.The physician has prescribed keflex and treated like cellulitis.The treating physician also prescribed benadryl and prednisone taper and pt.Was reported to be better in 5 days.Following resolution of the issue the patient presented at er 11 days later with cellulitis issues again.Patient was prescribed steroid taper again.The patient returned to the treating physician and the patient's calf has been described as swollen and a purple colour.The patient has been referred for a follow-up appointment with another physician.It was reported to the physician that the patient is allergic to ace inhibitors, fluorometholone acetate (steroid eye drops), doxycycline.Sensitivity to tape.Pt had a reaction to betadine, both legs, after the procedure.The patient also mentioned an allergy to prednisone.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient is finishing a second course of steroids.It was reported that the patient is status quo.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient is reported to be doing well, issue resolved.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 INC.,; parkmore business park west; galway,gw
• Manufacturer (Section G): MEDTRONIC INC.,; parkmore business park west; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8590620
• MDR Text Key: 144403257
• Report Number: 9612164-2019-01617
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• 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: 07/09/2019
• 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: 79 YR
• Patient Weight: 103