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

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

Patient Problems Ecchymosis (1818); Unspecified Infection (1930); Pain (1994); Phlebitis (2004); Numbness (2415); Thrombosis/Thrombus (4440)

Event Date 02/01/2022

Event Type  Injury  

Event Description

Hold for km 5.12 a journal article was submitted with the objective to determine the most effective modality of intervention to treat saphenous vein insufficiency.A systematic review and series of network meta-analyses of randomized controlled trials (rcts) were performed assessing risks of procedural failure (within 6-weeks) and recurrence (6-weeks to 5-years), defined by ultrasound, between the different modalities of intervention for superficial venous incompetence.Treatment comparisons addressing risks of common adverse events, venous clinical severity score, and pain were also performed.The review identified 51 articles, describing 36 randomized controlled trials, incorporating 7576 limbs.Endovenous interventions included endovenous laser ablation (evla), radiofrequency ablation (rfa), mechanochemical ablation (moca), ultrasound-guided foam sclerotherapy (fs), and cyanoacrylate adhesive closure (cae) whereas open procedures consisted of high ligation, with or without saphenous stripping, and ¿conservatrice hemodynamique de l¿insuffisance veineuse en ambulatoire (chiva).Hybrid interventions including high ligation with either truncal evla or fs were also described.Nineteen rcts (3774 limbs), describing 8 interventions, provided data for procedural failure.One study reported no failure in either cohort and was excluded.Cae significantly reduced the odds of procedural failure compared to rfa and moca.Evla significantly reduced procedural failure compared with fs alone.Forty-seven reports, containing 32 rcts described disease recurrence.Direct and indirect comparison of interventions revealed that those receiving fs were significantly more likely to experience disease recurrence at most time points (except 2-years) when compared with high ligation and stripping (hls).Patients receiving evla had significantly more recurrences when compared to hls at 2-years alone.At 6 months cae ranked as the best treatment to reduce recurrence and was statistically superior to rfa or moca and fs.No significant differences in recurrence rates were identified when endovenous techniques and hls were compared save those undergoing fs.At one-year, evla with high ligation followed by cae ranked first and second to reduce recurrence risk at 1-year.Neither intervention offered superiority over hls.Fs again ranked last and was associated with significantly higher rates of recurrence than all except high ligation and fs with ligation.At 2-5 years, chiva and hls ranked best with regard to recurrence rates up to 5-years.Hls was superior to evla and high ligation alone at 2-years and evla beyond 2-years.All interventions save high ligation and fs with ligation offered significantly lower rates of recurrence compared to fs alone.Twenty-nine reports, containing 27 rcts, reported adverse events.Pulmonary embolism (pe) was rare with only 2 events reported among 1865 treated limbs.Both affected patients underwent fs.No intervention significantly reduced the risk of dvt.Risks of other complications varied depending on the intervention.Hls increased the risk of hematoma when compared with endovenous interventions.Fs increased the risk of dyspigmentation when compared to hls respectively.Fs also increased the risk of phlebitis when compared hls, and evla with ligation.Although rfa increased the risk of paraesthesia when compared to evla, cae, fs with and without ligation, the data was statistically inconsistent.No intervention significantly reduced the risk of infection, ecchymosis, or thrombophlebitis.Five rcts examined postprocedural pain between 1-week to 1-month postintervention significantly reduced postprocedural pain when compared to all other treatment modalities by 1.3 to 2.83.Rfa and hls were all associated with less postprocedural pain scores when compared to evla.

Manufacturer Narrative

Title: outcomes of saphenous vein intervention in the management of superficial venous incompetence.A systematic review and network meta-analysis author: sara a.Gasior, john p.M.O¿donnell, thomas m.Aherne journal: annals of surgery year: 2022 vol/issue: 275(2) ref: 10.1097/sla.0000000000004914 a2: average age a3: majority gender b3: date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

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.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13595708
• MDR Text Key: 292050562
• Report Number: 9612164-2022-00782
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• 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: 45 YR
• Patient Sex: Female