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

Catalog Number	R06030
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed a thrombosis with the lifespan eptfe vascular grafts from lemaitre.The graft had been punctured for use while implanted.The graft was implanted on (b)(6) 2023.During reintervention, it was determined that the ptfe did not incorporate properly.No other complications were reported.Initial review of the available information suggests that there are (b)(4) cases where complications were experienced including incorporation issues, thrombosis and infection.A report is being submitted for each incident.
Additional Manufacturer Narrative
The product has not been returned for evaluation.Based on the information currently available, the exact root cause could not be determined.A thrombosis can potentially be related to how the device is handled, implanted and cared for after implantation.The exact cause of the reported issues is unknown.The ifu instructs to: use a tunneler to create a tissue tunnel that closely approximates the graft diameter.An oversized tissue tunnel may result in delayed or insufficient perigraft tissue attachment and may promote perigraft seroma formation.The ifu also explains the potential complications associated with this product: 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.Complications due to individual patient reaction to an implanted device, or to physical or chemical changes in the components, may necessitate reoperation and replacement (sometimes within hours or days) of the prosthetic device.Careful and continuous medical follow-up is advised so that prosthesis-related complications can be diagnosed and properly managed to minimize danger to the patient.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.Initial review of the available information suggests that there are (b)(4) cases where complications were experienced including incorporation issues, thrombosis and infection.A report is being submitted for each incident.

• 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
• MDR Report Key: 18667927
• Report Number: 1220948-2024-00036
• Device Sequence Number: 15235573
• Product Code: DSY
• UDI-Device Identifier: 00840663105199
• UDI-Public: (01)00840663105199
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/08/2024

1 Device 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: R06030
• Device Lot Number: LVG3678
• 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: 01/11/2024
• Initial Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2022
• 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