MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Insufficient Information (3190)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

Article received: go, c.E.(2020).Comparable patency of open and hybrid treatment of venous anastomotic lesions in thrombosed haemodialysis grafts.European journal of vascular and endovascular surgery, 897-903.Purpose: this study aimed to describe outcomes after hybrid intervention compared with open revision (patch venoplasty or jump bypass) of the va in thrombosed avgs.Method: retrospective cohort study.Consecutive patients with a thrombosed avg who underwent thrombectomy between january 2014 and july 2018.Conclusion: hybrid interventions for thrombosed avgs are not associated with worse patency at six and 12 months compared with open revision.Per the article adverse events included occlusion, bleeding, swelling, thrombosis and infection.

Event Description

N/a.

Manufacturer Narrative

Article received: go, c.E.(2020).Comparable patency of open and hybrid treatment of venous anastomotic lesions in thrombosed haemodialysis grafts.European journal of vascular and endovascular surgery, 897-903.The subject article is a single-center retrospective cohort study of 97 consecutive patients with a thrombosed arteriovenous graft (avg) who underwent thrombectomy between (b)(6) 2014 and (b)(6) 2018.Arteriovenous graft failures are typically associated with venous anastomotic (va) stenosis.This study aimed to describe outcomes after hybrid intervention compared with open revision (patch venoplasty or jump bypass) of the va in thrombosed avgs.This complaint is based on information found within a article/literature review.There was no product that was available for evaluation, therefore a device evaluation could not be conducted and the complaint cannot be confirmed.The author of the article did not report any major adverse patient effects as result of this event.A device history record (dhr) review was unable to be performed as the device product part number and lot number was not provided within the article.Attempts to obtain the device lot information was conducted but unsuccessful.The hazardous situation/harm is addressed in the risk file and is operating within its risk profile.There was no evidence within the article that the device was the cause of the reported event.The complaint history review did not identify an adverse trend, therefore no escalation to capa process is required.Conclusion: the instructions for use clearly states that potential adverse reactions of flixene vascular graft include, but may be not limited to: thrombosis, formation of pseudo-aneurysm due to excessive, localized, multiple and/or large needle punctures, perigraft hematoma formation, perigraft seroma formation or ultrafiltration, excessive needle hole elongation, mechanical disruption, material separation, delamination or tearing of the graft material, suture line or host vessel which may result in extreme blood loss, loss of limb function, loss of limb or possible death.Considering study design, that results were comparable to other clinical publications, noting possible risks and complications that can occur as a result of use of flixene vascular graft and fact that hybrid interventions for thrombosed avgs are not associated with worse patency at six and 12 months compared with open revision, one can infer that the getinge¿s flixene vascular grafts performed as expected.H3 other text : not available for return.

• Brand Name: FLIXENE VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 11558925
• MDR Text Key: 241927339
• Report Number: 3011175548-2021-00362
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 10/29/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention