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

Device Problem Biocompatibility (2886)

Patient Problems Cellulitis (1768); Nerve Damage (1979); Phlebitis (2004); Thrombosis/Thrombus (4440)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

Title: real-world short-term venaseal ablation outcomes for symptomatic saphenous incompetence author: morwan bahi, lucy guazzo, lupe taumoepeau journal: vascular year: 2022 vol/issue: 0(0) ref: 10.1177/17085381221077511, 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 retrospective, single-centre study reporting short-term outcomes following venaseal endovenous ablation for symptomatic saphenous incompetence.Patients were followed-up at 6-weeks post-procedurally by telemedicine or in-person clinic appointment without routine venous ultrasound assessment.235 patients were included in the study.Medtronic¿s venaseal device was implanted.All patients tolerated the procedure under local anaesthesia with no requirement for sedation or general anaesthetic.50% of patients underwent bilateral leg treatment during the same session.Phlebitis along the ablated vein occurred in 49 patients (21%).Phlebitis in those veins treated with foam sclerotherapy was common.Excluding phlebitis, only 33 complication events were noted, all being relatively minor.15 cases of residual varicose veins were noted on clinical examination during the follow-up visit, 9 cases of transient saphenous neuropraxia, based on symptoms reported by patients, six cases of puncture-site cellulitis requiring antibiotics, and three cases of deep vein thrombosis (dvt) in patients with no prior history of dvt.Those three patients were treated with oral anticoagulation with complete resolution.Outcomes are noted at the 6-week follow-up clinic appointment.Patients who experienced complication events received further clinic follow-up.

• 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: 13661045
• MDR Text Key: 287817591
• Report Number: 9612164-2022-00874
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• 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: 03/01/2022
• 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: 61 YR
• Patient Sex: Male