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

Catalog Number	R06080C80
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product remains implanted and was not available for investigation.Based on the available information, the reported event is due to user error.The site re-sterilized the graft with eo gas.The product is supplied sterile and is not intended to be sterilized by the user.The product label indicates that it is not intended to be sterilized.Additionally, as stated in the instructions for use: "this device is single-use only.Do not reuse, reprocess, or re-sterilize.The cleanliness and sterility of the re-processed device cannot be assured.Reuse of the device may lead to cross contamination, infection, or patient death.The performance characteristics of the device may be compromised due to reprocessing or re-sterilization since the device was only designed and tested for single use.The shelf life of the device is based on single use only." 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.We have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
It was reported that the customer used a graft that was re-sterilized with eo gas.The product was used for a femoral-popliteal bypass.During use, the lifespan eptfe vascular graft outer layer separated while removing spiral at the proximal anastomosis during suturing, with a length of 5-10 mm.The separation was confined to the proximal site of the graft, resulting in bleeding at the suture line.The patient experienced blood loss of 350cc from suture line bleeding.The bleeding was controlled by applying a hemostatic product at the proximal anastomosis and administering vitamin k.The patient was still in the hospital.No other injuries or complications reported to the patient.

• 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: 21859688
• Report Number: 1220948-2025-00073
• Device Sequence Number: 4684601
• Product Code: DSY
• UDI-Device Identifier: 00840663105601
• UDI-Public: (01)00840663105601(11)231031(17)300928(10)LVG3903A(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): 04/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: R06080C80
• Device Lot Number: LVG3903A
• 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: 03/22/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown