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

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ecchymosis (1818); Phlebitis (2004); Thrombosis/Thrombus (4440)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

Journal title: stump length changes after endovenous cyanoacrylate closure or radiofrequency ablation for saphenous vein incompetence the korean society for vascular surgery vasc specialist int 2021;37(1):14-21 ¿ https://doi.Org/10.5758/vsi.210006.If information is provided in the future, a supplemental report will be issued.

Event Description

Seventy-one patients were involved in a retrospective study in the treatment of incompetent saphenous vein.The aim of the study was to analyze the changes in stump length over time.The patients were divided into two treatment groups - cyanoacrylate closure (cac) and radiofrequency ablation (rfa).Venaseal occluding device was used in the cac groups and closurefast ablation device used in the rfa group.The great saphenous vein (gsv), short saphenous vein (ssv) and perforator veins were the veins treated.A total of ninety-seven veins (64 gsvs and 33 ssvs) were analyzed in the study.The clinical outcomes reported are recanalization of treated veins, ecchymosis, phlebitis like reaction and egit 2 (thrombus).

• 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: 11830709
• MDR Text Key: 251426719
• Report Number: 9612164-2021-01915
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• 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: 05/07/2021
• 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 Age: 59 YR