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

Catalog Number R06030

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

We have not received any of these reported grafts for evaluation.The clinical report was prepared by (b)(6) and was made available to us via our distributor in (b)(4).One hundred and eleven grafts were implanted between march 06, 2019 to may 03, 2019 in 111 hemodialysis patients to create an upper limb arteriovenous shunt.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.However, when the prosthesis becomes unobstructed, surgeon observed bleeding from the peri-prosthesis of the tunnel.This bleeding came from the puncture site of the prosthesis, which shows that the prosthesis was not incorporated.Incorporation involves the graft becoming densely fibrosed to soft tissues so that when needle cannulation is performed there is no potential space for hematoma formation.Puncturing a graft that is not well incorporated into the subcutaneous tissue may result in perigraft hematoma and subsequent infection.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 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.At this time, we could not conclusively determine the root cause of these incidents.

Event Description

A total of 111 grafts from lot# lvg2406 and lvg2407 were implanted between march 06, 2019 to may 03, 2019 in 111 different hemodialysis patients to create an upper limb arteriovenous.During de-clotting of the thrombosed grafts, surgeon observed a layer of the grafts were completely loose in its tunnel without any signs of incorporation to its surrounding tissues.This is report 3 of 3 of this series.Please note that we have reported mfg report# 1220948-2019-00122 and 1220948-2019- 00123 related to complications due to thrombosis and infection 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: 8971006
• MDR Text Key: 161531649
• Report Number: 1220948-2019-00124
• 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

• Date FDA Received: 09/06/2019
• 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
• Date Manufacturer Received: 08/07/2019
• 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