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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had great saphenous vein (gsv) treated with venaseal.4 days post procedure the patient phoned complaining of itching and redness on lower left leg.The patient also reported having redness and itching on hip, back, arms, and torso.Patient explained these were all areas where previous surgeries were carried out.The patient attended the physician¿s office the next day and was prescribed a medrol dose pack.The patient was referred to a dermatologist who prescribed mega doses of prednisone, doxycycline, and a cream.

Manufacturer Narrative

Additional information: hypersensitivity is still present and patient is still being treated with mega doses of prednisone, doxycyclin and a cream.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: four photographic images were received for evaluation.The first image is of the patient¿s lower left leg.The skin exhibits redness and swelling.Per the initial reported event description; four days post procedure the patient phoned complaining of itching and redness on lower left leg.The second image is of the patient¿s lower back.The skin exhibits redness like from a rash.Per the initial reported event description; the patient also reported having redness and itching on hip, back, arms and torso.Theses are areas that the patient has had previous surgeries carried out.The third image is of the patient¿s left hip and lower torso.The skin exhibits redness like from a rash.The fourth image is of the patient¿s left arm.The skin exhibits redness like from a rash.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: 9465367
• MDR Text Key: 170647413
• Report Number: 9612164-2019-05155
• 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
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: VS-402
• Device Lot Number: 54557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2020
• Date Device Manufactured: 02/07/2019
• 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: 75 YR
• Patient Weight: 104