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

Catalog Number SP-101

Device Problem Biocompatibility (2886)

Patient Problems Cellulitis (1768); Local Reaction (2035); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient received treatment of the short saphenous vein (ssv).A guidewire was used for insertion of the catheter.The procedure was completed as per ifu.The vein si reported to have closed.It is reported a few weeks post procedure the patient presented with problems which have not improved.The patient reported some edema and perimalleolar pain 2-3 weeks after the procedure.In the revision that the physician did 2 weeks after the treatment, everything was perfect.The patient returned for another check-up and edema and inflammation was noted around the ankle, but not noted along the course of the treated vein.Eco-doppler revealed vein closure and there were no signs of phlebitis of any collateral in the inflamed area.The physician suspected cellulitis and treated it.The edema is reported to have involved the foot and had lymphatic characteristics, so physician recommended that the patient started lymphatic drainage when the cellulitis improved.The inflammatory area is remaining despite the treatments, and also the foot edema.The physician has ordered a lymphogrammagraphy to evaluate that it is not a lymphedema (pending improvement of the inflammatory signs).It is also reported that in addition to the inflammatory signs in the ankle, it gives the impression that there is a retraction of the area instead of edema (as if there were an atrophy of the subcutaneous cellular tissue), and there is a hint of distal edema in the foot.It is reported to seems les and less like cellulitis, or a superinfection of the lymphedema (and in fact it does not improve despite several courses of antibiotics during these months).The physician has recommended the patient to have the lymphogrammagraphy and to consult with dermatology.The physician is unsure if this may be related in any way to an allergy or toxicity to any component of the vena seal.No further injury reported.

Manufacturer Narrative

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.

Manufacturer Narrative

Additional information: everything was gone right during and after procedure.Compression of gsv, the catheter tip was 5cm caudal to the saphenofemoral junction (sfj) prior to initial delivery of adhesive.Onset of symptoms about 3-4 months ago.The physician treated the patient with antibiotics but unknown which type.The lymphogram shows an absence of lymph nodes in the knee area with reduced lymphatic circulation in the extremity, and the nuclear medicine report states it as "lymphedema due to miizq hypoplasia".Reviewing the past medical history and re-interviewing the patient, patient already referred some edema of the extremity and pain in the area for several months before the surgery, and in fact it was the reason for the first visit.At that time ((b)(6) 2021) the edema was less important than now, and there was no evident inflammatory area, so in view of the finding of an insufficient external saphenous vein with a diameter of 12mm, the physician decided to operate.In retrospect, the patient probably had a mixed clinical picture of both problems and co inciding with the solution of the varicose veins the lymphedema has worsened.Physician also asked patient again if at any time during the postoperative period she had pain or redness along the course of the treated vein, and she denied it: the course of the external saphenous vein did not cause any problem at any time.Physician has again performed a control venous doppler ultrasound, which was perfect: the internal saphenous vein is absent (patient had undergone stripping surgery 18 years ago) and with no signs of recurrence, and the external saphenous vein (which is the one treated with the venaseal) is perfectly occluded.There is no involvement of the deep venous system, which is completely normal, so from this point of view everything is correct.The physician referred patient to a lymphedema and referred her to a lymphatic therapist to start treatment with lymphatic drainage.But physician also referred patient to internal medicine so that they could rule out that this patient did not have something else (a rheumatologic disease such as plaque scleroderma, for example, or another cause of chronic systemic inflammation) and also that they could rule out a possible immunosuppression of some kind, which could predispose her to repeated infections.Internal medicine commented that it could be due to sequelae of cellulitis, patient has lymphedema without significant lymph node blockage in the knee area.After the doctor recommended lymphatic drainage and compression stockings, physician has not heard from the patient since.The physician¿s personal opinion remains that the patient's condition is not related to the venaseal treatment rather than a temporary coincidence (worsening of a lymphedema that had probably started before).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.

Manufacturer Narrative

Product analysis: two image files was returned for review: image 1 and 2: both images shows the patients ankle with visible signs of inflammatory around the ankle area consistent with the reported event.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12698231
• MDR Text Key: 278383753
• Report Number: 9612164-2021-04080
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: SP-101
• Device Lot Number: 62839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Date Device Manufactured: 02/28/2021
• 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 Sex: Female