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

Catalog Number SP-101

Device Problems Migration or Expulsion of Device (1395); Defective Device (2588); Biocompatibility (2886)

Patient Problem Local Reaction (2035)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal occluding device during procedure to treat the great saphenous vein (gsv) and short saphenous vein (ssv).Hand was used for compression.The lumen was flushed prior to use.Ifu was not followed.It was reported that physician continued manually because of the pistol trigger failure.The procedure was completed manually.This is an experienced physician who succeeded to manage the failure of the pistol.Unfortunately in this caused the patient to experience big problems.It was reported that the right leg was treated by pistol until end delivery and continued manually by pushing the syringe.Hereafter physician treated the left leg fully manually.Four months after treatment, glue migrates through vein walls on duplex and clinical.Sterile abscess needs to be drained.Still ulceration on new location noted (every 3cm).Strong and severe superficial complaints starting approximately 2 months post procedure.Patient was first treated with vimovo (combination of naproxen and esomprazole).Was not enough 9 days later.On duplex, the adhesive true vein walls was significant on duplex; brufen 1800mg/day was not enough 10 days later.Steroids was prescribed in high doses 128mg/day, and slowed down over a month.When this was stopped;.Painkillers with nsaid in combination with tradonal odis and dafalgan were prescribed.No further injury reported.

Manufacturer Narrative

Image review the customer returned 4 photographic images for review.Image 1: the first image was a photograph of the patient¿s left leg.A abscess was noted on the patients left calf.It was also noted that the skin surrounding the abscess was red and inflamed.There appeared to be a white discoloration within the abscess, suggesting pus.A second area of red discoloration was noted distal to the abscess.No adhesive was observed at the site.Image 2: the second image appeared to be post-cleaning of the abscess on the left calf.It was observed that there was a depression within the observed abscess after cleaning.It was noted that the second area of red discoloration was also drained and cleaned.No venaseal adhesive could be identified in the photograph.Image 3: the third photograph showed the red discoloration above the patient¿s right ankle.Due to the angle of the photograph the presences of an abscess could not be discerned.No venaseal adhesive was observed in the photograph.Image 4: the fourth image contained the patient¿s calf.The location was consistent with the patient¿s left calf.Three areas of redness were observed along the patient¿s calf.Two of the areas appeared to be inflamed and bulbous.It appeared that pus may have been leaking from one of the abscesses.The venaseal adhesive could not be identified in the photograph.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): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11752962
• MDR Text Key: 248216057
• Report Number: 9612164-2021-01749
• 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
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• 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: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention