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

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problems Foreign Body Reaction (1868); Granuloma (1876); Hypersensitivity/Allergic reaction (1907); Injury (2348); Reaction (2414)

Event Date 08/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a venaseal closure system for the treatment of two segments of the left gsv.Ifu was followed.Local anesthesia was used.Compression was not performed.Patient has a history of thrombosis on her left leg.It was reported that few days after the procedure the patient presented with painful redness on top of treatment area which was treated with anti-inflammatory drugs, with improvement in condition.The patient also had breast infection during the same period, which was treated with antibiotics, in parallel also with anti-histamines with no improvement.Five weeks after the procedure, the patient suffered swelling in the shin and skin colour had changed to brown.In addition, two spots were also observed in the area and they were rigid/stiff.A duplex ultrasound was carried out and two spots were found which looked like two small masses under the skin.Clinical picture of the shin showed spots seems a reaction to the glue, patient had granuloma.Physician then diagnosed left leg phlebitis-like reaction following glue treatment for varicose veins with suspected f.B.Granuloma.Left leg phlebectomy for non-saphenous varicose vein with resection of area of suspected granuloma formation was treatment physician proposed.

Manufacturer Narrative

Additional information: symptoms experienced approximately 5 weeks post initial procedure.Patient experienced returned to physician one-week post onset of symptoms.The catheter tip was placed 5cm caudal to the sapheno femoral junction (sfj).Compression was applied with the probe during procedure.The patient is scheduled to have a phlebectomy procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Video/image review: video, photographs and sonogram images were provided for evaluation.Clinical review confirms the customer's reported events align with the received media.The provided images show a excised mass from the mid-thigh, which appeared to surround the gsv.The vein looked somewhat intact within the mass.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: a new spot has been observed in the thigh area, in the first segment treated with venaseal.This is similar to the spot observed in the shin, but less severe.After puncturing the spot with a syringe, a small amount of liquid with gel consistency like was noted.The physician confirmed that there was no presence of glue, pus or signs of infection/fever.Patient is feeling pain in the area but there is no pruritus.The patient was prescribed oral steroids.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient has refused to take the steroid treatment prescribed.The spot was diagnosed as foreign body granuloma.Pain has slightly improved.Patient has requested the affected part of the vein to be removed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient is doing fine after phlebectomy.The foreign body granuloma was removed with minimal scarring.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: excision biopsy (phlebectomy procedure) of the granuloma has been carried out.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient is doing fine and has no symptoms.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: 8968804
• MDR Text Key: 156715811
• Report Number: 9612164-2019-03783
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/17/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: SP-101
• Device Lot Number: 52576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/08/2019; 09/12/2019; 09/30/2019; 10/10/2019; 10/25/2019; 11/01/2019; 11/19/2019; 12/12/2019
• Supplement Dates FDA Received: 09/10/2019; 09/16/2019; 10/02/2019; 10/18/2019; 10/30/2019; 11/05/2019; 12/04/2019; 12/17/2019
• Date Device Manufactured: 08/29/2018
• 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): Other
• Patient Age: 32 YR