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); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Phlebitis (2004); Thromboembolism (2654); Paresthesia (4421)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

Title: interventions for great saphenous vein reflux: network meta-analysis of randomized clinical trials author: b.Siribumrungwong, c.Wilasrusmee, s.Orrapin journal: bjs society year: 2021 vol/issue: 108 ref: 10.1093/bjs/znaa101.Average age, majority gender, date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a systematic review and network meta-analysis of randomised control trials (rcts) to compare rates of incomplete stripping or non-occlusion of the great saphenous vein with or without reflux (anatomical failure) at early, mid- and long-term follow-up; and secondary outcomes (reintervention and clinical recurrence) among intervention groups.Some 72 rcts were included.Radiofrequency ablation (rfa), endovenous laser ablation (evla), ultrasound-guided foam sclerotherapy (ugfs), mechanochemical ablation (moca), and cyanoacrylate closure (cac methods were included.Anatomical failure (incomplete stripping or gsv non-occlusion with or without reflux) was regarded as the primary outcome of interest.Secondary outcomes included postoperative complications (wound infection, haematoma, paraesthesia and venous thromboembolism), postoperative pain, time to recovery, venous clinical severity score (vcss), aasv reflux, neovascularization, clinical recurrence, reintervention, and quality of life as measured by the aberdeen varicose vein questionnaire (avvq).48 original rcts were assessed for qualitative and risk-of-bias assessment.Duration of follow-up ranged from 0.5 months to 8 years, with 18 of the 48 studies reporting long-term outcomes (more than 3 years).Related to anatomical failure, when comparing rfa to open surgery, there were 14 events per 367 patient¿s in the periprocedural rfa group, 17 per 261 in the early rfa group, and 19 per 245 in the midterm rfa group.On comparison of evla and rfa, the reported events per patient¿s in the rfa groups were 2 of 383, 140 of 1067, and 28 of 423 in the periprocedural, early and midterm groups.Comparing cac and endothermal, 20 events per 483 patients¿ are reported in the cac group.When comparing moca and rfa, 10 of 222 events per patient were reported in the rfa group.Rfa showed lower rates of neovascularization and clinical recurrence than open surgery, but none was significantly different.Postoperative complications were also assessed.Clinical events of thromboembolism, wound infection, hematoma, paraesthesia, ecchymosis, and superficial thrombophlebitis in the non-thermal non-tumescent (ntnt) (incl.Cac) and rfa groups.Post-operative pain is also reported for the treatment methods compared.Ranking indicated that cac was ranked top in lowering postoperative pain, followed by moca, rfa, ugfs, evla and open surgery.Values for cac indicated low anatomical failure and low postoperative pain for both midterm and long-term follow-up.Rfa was associated with 3¿4 and 4¿8 days shorter return to normal activities and work compared with open surgery.Ntnt had significantly reduced time to normal activities compared with endothermal ablation but this was not significantly different for time to work.

Manufacturer Narrative

Title: interventions for great saphenous vein reflux: network meta-analysis of randomized clinical trials author: b.Siribumrungwong, c.Wilasrusmee, s.Orrapin journal: bjs society year: 2021 vol/issue: 108 ref: 10.1093/bjs/znaa101.Age or date of birth: average age, sex: majority gender, date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a systematic review and network meta-analysis of randomised control trials (rcts) to compare rates of incomplete stripping or non-occlusion of the great saphenous vein with or without reflux (anatomical failure) at early, mid- and long-term follow-up; and secondary outcomes (reintervention and clinical recurrence) among intervention groups.Some 72 rcts were included.Radiofrequency ablation (rfa), endovenous laser ablation (evla), ultrasound-guided foam sclerotherapy (ugfs), mechanochemical ablation (moca), and cyanoacrylate closure (cac methods were included.Anatomical failure (incomplete stripping or gsv non-occlusion with or without reflux) was regarded as the primary outcome of interest.Secondary outcomes included postoperative complications (wound infection, haematoma, paraesthesia and venous thromboembolism), postoperative pain, time to recovery, venous clinical severity score (vcss), aasv reflux, neovascularization, clinical recurrence, reintervention, and quality of life as measured by the aberdeen varicose vein questionnaire (avvq).48 original rcts were assessed for qualitative and risk-of-bias assessment.Duration of follow-up ranged from 0.5 months to 8 years, with 18 of the 48 studies reporting long-term outcomes (more than 3 years).Related to anatomical failure, when comparing rfa to open surgery, there were 14 events per 367 patient¿s in the periprocedural rfa group, 17 per 261 in the early rfa group, and 19 per 245 in the midterm rfa group.On comparison of evla and rfa, the reported events per patient¿s in the rfa groups were 2 of 383, 140 of 1067, and 28 of 423 in the periprocedural, early and midterm groups.Comparing cac and endothermal, 20 events per 483 patients¿ are reported in the cac group.When comparing moca and rfa, 10 of 222 events per patient were reported in the rfa group.Rfa showed lower rates of neovascularization and clinical recurrence than open surgery, but none was significantly different.Postoperative complications were also assessed.Clinical events of thromboembolism, wound infection, hematoma, paraesthesia, ecchymosis, and superficial thrombophlebitis in the non-thermal non-tumescent (ntnt) (incl.Cac) and rfa groups.Post-operative pain is also reported for the treatment methods compared.Ranking indicated that cac was ranked top in lowering postoperative pain, followed by moca, rfa, ugfs, evla and open surgery.Values for cac indicated low anatomical failure and low postoperative pain for both midterm and long-term follow-up.Rfa was associated with 3¿4 and 4¿8 days shorter return to normal activities and work compared with open surgery.Ntnt had significantly reduced time to normal activities compared with endothermal ablation but this was not significantly different for time to work.

• 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: 13618244
• MDR Text Key: 286233556
• Report Number: 9612164-2022-00816
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P140018
• 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
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• 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): Hospitalization