The product has not been returned for evaluation.Based on the information currently available, the exact root cause could not be determined.An infection 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.Patient monitoring is essential when the graft is used for vascular access to prevent excessive damage from complications such as infiltration, infection, thrombosis, embolism etc.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 the device may lead to cross contamination, infection, or patient death.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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It was reported that the patient developed an infection with the lifespan eptfe vascular grafts from lemaitre.The graft was not 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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