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

Catalog Number	R06080C80
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not available for return.However, the photo provided was reviewed and confirmed the reported issue.While the event was verified, the exact root cause could not be determined.It is possible to damage the graft if it is handled incorrectly by the user.As stated in the ifu: "when using a graft with removable external ptfe monofilament support, slowly unwind the monofilament at a right angle to the graft.Be careful to avoid removal of the thin spirally wrapped eptfe tape.Rapid unwinding and/or removal of the monofilament support parallel to the axis of the graft may damage the product.The production and traceability record for the device was reviewed; no issues were found during manufacturing or packaging that would cause or contribute to the reported event.All quality control tests were completed successfully and met specification.Further, we have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported that during a procedure, the lifespan eptfe vascular graft separated when the external spiral support was removed.The damaged portion of the graft was cut off, and the remaining usable portion was implanted.

• 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: 24314150
• Report Number: 1220948-2026-00020
• Device Sequence Number: 5572879
• Product Code: DSY
• UDI-Device Identifier: 00840663105601
• UDI-Public: (01)00840663105601(11)240522(17)310428(10)LVG00004243(91)R06080C80
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: R06080C80
• Device Lot Number: LVG00004243
• 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: 01/16/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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