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

Catalog Number	R06050
Medical Device Problem Codes	Fluid/Blood Leak (1250); Structural Problem (2506); Thickening of Material (4056)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not available for evaluation as it remains implanted.Based on the current information, there is no confirmed failure.Due to the nature of the product, there is some variability in graft diameter between devices and catalogue number.Each lot is tested for water entry pressure, suture retention, and burst pressure.The lot history record was reviewed, during manufacturing all test samples passed testing for this lot.It is likely that the surgical technique contributed to the reported incident.As stated in the ifu, the potential complications with the use of this device include: life threatening complications which may occur in conjunction with the use of any vascular prosthesis include, but are not limited to: excessive suture hole bleeding; thrombosis; thromboembolic complications; infection; ultrafiltration or perigraft seroma; swelling of limbs; pseudoaneurysms; perigraft hematomas; skin erosion; steal syndrome; preoperative hemorrhage; aortoenteric fistula.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 the lifespan is thicker than usual and not conforming well when sutured, which caused bleeding at the suture holes during a arteriovenous bypass graft procedure.The procedure lasted longer from stopping the bleeding.No further complications or injury was reported.

• 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: 19558927
• Report Number: 1220948-2024-00120
• Device Sequence Number: 4734774
• Product Code: DSY
• UDI-Device Identifier: 00840663105199
• UDI-Public: (01)00840663105199
• 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): 06/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: R06050
• Device Lot Number: LVG3901
• 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: 05/19/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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: Other
• Patient Sex: Unknown