H10: manufacturing review: 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: a physical sample was returned for evaluation and the stent was found partially deployed.During testing, the entire lumen of the delivery system was successfully flushed, a device compatible guidewire could go through the delivery system successfully and the stent could be further deployed using the trigger.The investigation is closed with confirmed results for partial deployment.It was reported that a 180cm guidewire / 10f introducer were used for access, the tracking vessel was not tortuous and the vessel was pre-dilated.The device was intended to be placed in a tips procedure which represent an off-label use, and which was considered a significant factor.Based on available information and evaluation of the returned sample, the investigation was closed with confirmed results for partial deployment.A definite root cause for the reported event could not be determined.The intended placement of the device in a transjugular intrahepatic portosystemic shunt (tips) procedure represents an off-label use.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".Regarding general directions, the instructions for use states "pre-dilatation of the stricture is recommended.Selection of an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician.".Regarding accessories, the instructions for use states "the bard s.A.F.E.R 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" guide wire.The instructions for use states "the e-luminexx vascular stent is indicated for the treatment of atherosclerotic lesions in the common and external iliac artery".H10: d4 (expiration date: 06/2026).H11: section a: through f: the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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