MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC LIFESPAN EPTFE VASCULAR GRAFT

Catalog Number	R06050
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product remains implanted and is not available for investigation.However, the photo provided confirmed the report.It shows a slight tear on the inner base layer (base tube) of the graft.We were unable to determine if the damage occurred during the manufacturing process or during the operation.The base tube was sutured to resolve the issue and it was stated no injury occurred to the patient.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.
Event or Problem Description
It was reported that on april 26, a lifespan graft was implanted in a loop configuration during an arteriovenous (av) shunt creation procedure.Following the implantation, approximately eight punctures were performed for dialysis.Subsequently, graft occlusion was observed and a thrombectomy was scheduled.Upon surgical incision for thrombectomy, a tear was identified in the inner layer of the graft (the base tube).The tear in the base tube was located away from the puncture sites (the physician has not clearly determined the cause).It is noted that there was no blood leakage, as the outer wrapping of the graft remained intact and functional.Thrombectomy was not performed, and the tear in the base tube was sutured, concluding the procedure.No injury was reported to the patient.The graft remains implanted and not available to be returned for investigation.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Common Device Name: VASCULAR 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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 22327849
• Report Number: 1220948-2025-00102
• Device Sequence Number: 12864708
• Product Code: DSY
• UDI-Device Identifier: 00840663105199
• UDI-Public: (01)00840663105199(11)240415(17)310328(10)LVG00004188(91)R06050
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: R06050
• Device Lot Number: LVG00004188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown