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

Catalog Number	T07050C50
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after cutting the lifespan to the appropriate length, the outer coating peeled off together with the spiral support during removal.The peeled coating looked like it had been shredded into fibrous strands.The peeled coating was carefully trimmed, and the lifespan was used as is.No injury was reported to the patient.
Additional Manufacturer Narrative
The product was not returned for investigation as it was implanted.However, the photo provided shows an example of the reported issue.Therefore, we could not conclusively determine the root cause of the reported incident.While the reported event was confirmed, the exact root cause of the reported issue could not be determined.Per 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.Suture technique: disruption of the graft, host vessel, and/or suture lines may occur if appropriate suture techniques are not observed.Utilize a small diameter, tapered, noncutting needle to prevent bleeding from suture holes." we have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.

• 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: 22680020
• Report Number: 1220948-2025-00128
• Device Sequence Number: 9664115
• Product Code: DSY
• UDI-Device Identifier: 00840663105687
• UDI-Public: (01)00840663105687(11)240708(17)310628(10)LVG000043333(91)T07050C50
• 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): 07/31/2025

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: T07050C50
• Device Lot Number: LVG00004333
• 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: 07/04/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2024
• 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