MAUDE Adverse Event Report: SAPHEON INC VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Catalog Number SP-101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pulmonary Infarction (2021); Thrombosis (2100); Ulcer (2274); Reaction (2414)

Event Date 07/06/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a venaseal closure system for treatment of the gsv under local anesthesia.Two segments were treated (45cm in two sections due to tortuous section of vein) and the vein did close.It was reported the procedure went well, but a few days post-procedure ((b)(6) 2017), the patient began to experience issues (severe thrombophlebitis or allergic reaction post venaseal treatment).Initially patient was prescribed antibiotics for potential infection but then became unwell and was admitted to the hospital (crp was 330 and white blood cell 12).Patient was prescribed iv antibiotics and hydrocortisone; the full length of treated vein was inflamed.It was reported that patient was then prescribed prednisone and infection started to settle down.Patient was in hospital for 12 days; finished prednisone and inflammation in leg is settling down.Patient also developed chest pain and ct showed pulmonary embolism.Ct has shown tail of dvt into femoral vein of treated leg.

Manufacturer Narrative

Patient age was reported as approximately 50 years old.Patient weight was reported as approximately 70-80.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Physician has confirmed that the patient is now doing fine.Symptoms of pe were mild and have resolved.Leg inflammation has also subsided.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient has begun to get an ulcer on the mid-thigh over the area of treated vein (above the access site).Physician has commented that it looks like the venaseal is working its way out of the ulcer.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: three photographic collages were received consisting of nine photographic images.The first photographic collage consists of three photographs of a patient¿s left thigh.Redness and swelling can be observed in the photographs along the treated great saphenous vein, (gsv).Per the reported event description four-days post-procedure the patient was seen for extreme pain.Severe thrombophlebitis or allergic reaction post venaseal was evident.Initially patient was prescribed antibiotics, nsaid¿s, and anti-histamines for potential infection but then became unwell and symptoms were reported to have worsened by post op day six.The photographs are most likely from this first post-procedure follow-up office visit.The second photographic collage consists of two photographs of a patient¿s left thigh.The redness along the treated gsv is more lo calized into three distinct areas.In one of the photos blistering and scabbing is observed in the localized area of redness.The third photographic collage consists of four photographs.The top photograph in the collage is of what appears to be two foreign material masses removed from the treated vein.Per the reported event description, 12-weeks post procedure glue was discharged from the thigh wounds.The three lower photographs are of the treated left thigh and shows three areas of redness along the treated gsv.The upper most area of redness exhibits either a wound or an incision from a venectomy.Per the reported event description, the patient underwent a high tie procedure and venectomy of the treated gsv.Five months post high tie and venectomy a sarcoma formed and was treated conservatively.Patient displayed prominent varicosities along distribution of the left gsv , and a 4x5cm ulcer on examination.Venous doppler showed incompetent left gsv throughout its length.The left sapheno-femoral junction was also reported as being incompetent.For the first day following the procedure the patient wore class ii compression stockings.4 days post-procedure the patient was seen for extreme pain.Nsaid¿s and anti-histamines were also prescribed initially.Symptoms were reported to have worsened by post op day 6, when patient was admitted to hospital.The pe developed 6 weeks post procedure.The patient was started on warfarin.On physical examination, skin necrosis was evident.12 weeks post procedure, glue was discharged from the thigh wounds.A repeat scan was undertaking which demonstrated the patency of the deep veins on the left.Patient was listed for high tie and venectomy of the left gsv.Following this, 5 months post procedure high tie and venectomy, a seroma was evident in the high thigh which was managed conservatively.3 months later, the seroma was reported to be infected and was incised and drained.2 months following this the patient wounds were reported to be healed and the patient was discharged from further follow-up.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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): SAPHEON INC; 951 aviation pkwy ste 900; morrisville NC 27560
• MDR Report Key: 6799387
• MDR Text Key: 82862664
• Report Number: 3011410703-2017-00321
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 70