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 Bruise/Contusion (1754); Phlebitis (2004); Skin Discoloration (2074); Paresthesia (4421); Insufficient Information (4580)

Event Date 08/11/2021

Event Type  Injury  

Event Description

A journal article was submitted detailing a study to assess the effects of endovenous laser ablation (evla), radiofrequency ablation (rfa), endovenous steam ablation (evsa), ultrasound-guided foam sclerotherapy (ugfs), cyanoacrylate glue, mechanochemical ablation (moca) and high ligation and stripping (hl/s) for the treatment of varicosities of the great saphenous vein (gsv).Technical failure was defined as "an open refluxing segment of 10cm or more at follow up" reported in both groups.Complications reported for rfa treatment included pain, hematoma, saphenous nerve injury (paraesthesia), thermal injury or inflammation (skin burn and phlebitis), wound problems (groin/ stab), bruising and pigmentation, skin staining, pulmonary embolism,dvt, ehit and phlebitis from the included studies.Minor complications reported for ca treatment included saphenous nerve injury, bruising and pigmentation, and chronic phlebitis from the included studies.Wound problems requiring intervention are reported for rfa and ca.

Manufacturer Narrative

Title: interventions for great saphenous vein incompetence (review) author: whing j, nandhra s, nesbitt c, stansby g journal: cochrane database of systematic reviews year: 2021 vol/issue: 8 ref: 10.1002/14651858.Cd005624.Pub4.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: 13635763
• MDR Text Key: 286347520
• Report Number: 9612164-2022-00832
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111887
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• 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