MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LIFESPAN EPTFE VASCULAR GRAFT; PROTHESIS, VASCULA GRAFT

Catalog Number R06030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

We have not received any of these reported 11 grafts for evaluation.The clinical report was prepared by (b)(6) and was made available to us via our distributor in (b)(4).Out of 111 grafts that were implanted between (b)(6) 2019 to (b)(6) 2019 in 111 hemodialysis patients to create an upper limb arteriovenous shunt, 11 grafts required intervention due to cases of infection.As a result, surgeon had to explant the grafts making the limbs of these patients not viable to grow any new fistula.According to the report, there were no complications during the index procedure.The initial punctures of the fistulas were performed after 30-40 days allowing the graft to incorporate to its surrounding tissues and to avoid any peri-prosthetic hematomas.The arteriovenous fistula (avf) is a preferred method for hemodialysis access.However, placing an avf in all patients may result in poor access outcomes and increased central venous catheter (cvc) use because of increased comorbid conditions, age, and suboptimal vessels.In patients with inadequate superficial veins for avfs, the use of the brachial veins for creation of forearm arteriovenous grafts (avgs) has been preferred.As established in the clinical world, these arteriovenous grafts are not considered the "gold standard" for dialysis access as it has certain disadvantages when compared to the other types of hemodialysis vascular access.These grafts does not last as long as an av fistula does and are more prone to clotting and infection than the native vein fistulas.However, the benefits of these grafts outweighs the risk associated with the use of these avgs.As stated in our ifu, the lifespan eptfe vascular graft is supplied sterile and non-pyrogenic if the package has not been previously opened and is undamaged.Provided that the integrity of the package is not compromised, the package will serve as an effective barrier for a minimum of 7 years from the sterilization date.Our review of the lot history records for these lots did not find any discrepancies either in the manufacturing or packaging process that could be related to these incidents.All of the pre and post-sterilization qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from these lots from other customers.Our review of complaint database for last 5 years for this product line did not reveal any other complaints that are related to infection.Our ifu properly describes all of the potential complications that may occur with the use of any vascular prosthesis including, but are not limited to excessive suture hole bleeding, thrombosis, thromboembolic complications; infection; ultrafiltration or perigraft seroma, swelling of limbs, pseudoaneurysms, perigraft hematomas, skin erosion, steal syndrome, preoperative hemorrhage, aortoenteric fistula.Careful and continuous medical follow-up is advised so that prosthesis-related complications can be diagnosed and properly managed to minimize danger to the patient.Patients with end-stage renal disease affects the body's natural immune system, increasing the risk of developing infections, including antibiotic-resistant infections.We have also consulted this series of incident with our medical director.According to him, 'patients undergoing hemodialysis access are already compromised to the extent that they have less ability to respond to infectious and neoplastic challenges.Additionally, outcomes of reconstructive vascular procedures, particular those with diabetes, are inferior to the outcomes in patients without renal compromise.Ptfe does have a greater likelihood for early thrombosis and potential for infection, often based on the need for repetitive needling.' strains of staphylococcus are the most frequent cause of infected avg since it can spread from person to person or from objects such as towels, clothing, etc.We have requested for additional information including strain of bacteria that were identified, site of infection for each incident.As of now, we have not received these information.Repetitive breaks in skin integrity allow infection to reach the avg with most of the infection occurring at the site of avg needle insertion.Infections may occur at the graft site because of the lack of asepsis during implantation (cannulation techniques themselves involve the risk of infection), hematoma formation, or clogging.Other factors, including immunosuppression resulting from neutrophil dysfunction, uremia, patient obesity, diabetes, hypoalbuminemia, and poor personal hygiene.Implants, as with all other vascular prostheses, are prone to infections caused by penetration of the hematogenous route.Bacteria adhere more strongly to the synthetic material of the avg, leading to resistance of the host defenses compared with native avfs.Based on our investigation, we do not consider lifespan eptfe vascular grafts caused infection in these patients.The cause is most likely related to patient's pre-existing conditions along with failure to follow asepsis techniques during cannulation.

Event Description

A total of 111 grafts from lot# lvg2406 and lvg2407 were implanted between (b)(6) 2019 to (b)(6) 2019 in 111 different hemodialysis patients to create an upper limb arteriovenous.Out of these 111 grafts, 11 grafts showed signs of infection and required removal of the graft.This is report 2 of 3 of this series.Please note that we have reported mfg report# 1220948-2019-00122 and 1220948-2019-00124 related to complications due to thrombosis and lack of graft incorporation to its surrounding tissue that were also encountered in this series.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Type of Device: PROTHESIS, VASCULA GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC,; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 8971008
• MDR Text Key: 161516842
• Report Number: 1220948-2019-00123
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00840663105182
• UDI-Public: 00840663105182
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2019

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
• Device Expiration Date: 02/09/2018
• Device Catalogue Number: R06030
• Device Lot Number: LVG2406 AND LVG2407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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