The catalog number identified has not been cleared in the us but is similar to the e-luminexx vascular stent products that are cleared in the us.The pro code and 510 k number for the e-luminexx vascular stent products are identified.Manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the stent delivery system was returned for evaluation, during sample evaluation, the guiding tube was partially detached from the performaxx handgrip and luer port adapter.The stent was partially deployed.A deployment attempt was successful.In this case, the customer complained that during operation of the device, the trigger got stuck and the stent could not be released.The size of the guidewire used was not stated.Therefore, the investigation is confirmed for detachment and partial deployment.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.With regards to general warnings, the instructions for use states that "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit".With regards to device warning, the instructions for use states that "visually inspect the bard e luminexx vascular stent to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".Regarding accessories, the instructions for use states "the bard s.A.F.E.6f delivery system requires a minimum 8f guiding catheter or a minimum 6f introducer sheath" also "via the femoral route, insert a 0.035¿ (0.89 mm) guide wire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.With regards to indications for use, the instructions for use states that the stent is to be used on femoral and iliac arteries.Based on reported information, the intended placement site for this stent was the venous system which represents off-label use.(expiry date: 01/2024).
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It was reported that during a stent placement procedure through a puncture in the right jugular vein via an antegrade approach, the stent release handle got stuck and as a result, the stent allegedly failed to deploy.It was further reported that the device allegedly partially deployed.The device was removed off the patient.The procedure was completed using another device.There was no reported patient injury.
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