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

Catalog Number R06030

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/23/2023

Event Type  Injury  

Event Description

It was reported that the patient developed a thrombosis with the lifespan eptfe vascular grafts from lemaitre.The graft was punctured once 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.

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
• Type of Device: 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: 18671113
• MDR Text Key: 334950666
• Report Number: 1220948-2024-00040
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K130016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R06030
• Device Lot Number: LVG3631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention