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

Catalog Number	R08080C80
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for investigation; therefore, the root cause could not be determined.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.Due to similar previous complaints capa 2022-013 was opened to further investigate this issue.Note: this is report 3 of 4 related to the third graft used in the event.Report 1220948-2024-00047, 1220948-2024-00048, and 1220948-2024-00050 were submitted for the first, second, and fourth devices involved in this event.
Event or Problem Description
It was reported that four lifespan graft external support became undone after tunneling during a peripheral bypass lower extremity procedure.It was not determined if the grafts were checked prior to use.No injury was reported to the patient.Note: this is report 3 of 4 related to the third graft used in the event.Report 1220948-2024-00047, 1220948-2024-00048, and 1220948-2024-00050 were submitted for the first, second, and fourth devices involved in this event.

• 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: 18728217
• Report Number: 1220948-2024-00049
• Device Sequence Number: 14849680
• Product Code: DSY
• UDI-Device Identifier: 00840663105649
• UDI-Public: (01)00840663105649
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2024

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: R08080C80
• Device Lot Number: LVG3923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2023
• 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