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 14 cases where complications were experienced including incorporation issues, thrombosis and infection.A report is being submitted for each incident.
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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 14 cases where complications were experienced including incorporation issues, thrombosis and infection.A report is being submitted for each incident.
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