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 Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)

Event Date 11/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During procedure, physician used venaseal occluding device to treat a segment in the great saphenous vein (gsv) successfully.Two days later, patient called physician to complain of redness and itching on treated leg.Physician prescribed a cortisone cream for the treated leg.Four days post procedure, patient called to report a mild rash on the treated elg and was asked to come in for a doppler scan.Five days post procedure, patient called in, no dvt was noted and again patient was sent home with cortisone cream and nsaids.Seven days post procedure, patient traveled to (b)(6) and went to an urgent care for a moderate rash and itching, and patient was prescribed a medtrol dose pack.Patient's symptoms improved but returned towards end of medrol dose pack and have now spread to buttocks and shoulder.Thirteen days, patient visited the treatment clinic and physician is referred to waves study to make an informed decision on a course of treatment.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: the rash has resolved and the patient is doing fine.The vein is closed.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.

Manufacturer Narrative

Additional information: 1.7cc of adhesive was delivered to the vessel and 55cm of the right great saphenous vein was treated.Patient is on medrol dose pack and benadryl po.Patient will be seen by a dermatologist.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: 9384522
• MDR Text Key: 168250534
• Report Number: 9612164-2019-04929
• 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,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 52806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2020
• Date Device Manufactured: 09/17/2018
• 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
• Patient Age: 67 YR
• Patient Weight: 93