H10: 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 sample was returned for evaluation.Based on the investigation of the returned catheter sample it was confirmed that the user could only partially deploy the stent graft.The deployment mechanism was found in used condition, and one stent graft strut was found perforating the outer sheath in the tip section which made a complete stent graft deployment impossible.In this case, the device was flushed, a 10f introducer sheath was used; the tracking vessel was not tortuous and/ or calcified.As a result of the investigation performed the complaint is confirmed for strut perforation.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.The instructions for use states: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' regarding the anatomy of the placement site the instructions for use states: 'prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure.' furthermore, the instructions for use states: 'prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (¿).Flushing these lumens will also facilitate stent graft deployment.' under materials required the instructions for use states 'introducer sheath with appropriate inner diameter' and the packaging labels state a minimum introducer size of 10f.H10: d4(expiry date: 10/2023),g3.H11: section a through f ¿ the information provide 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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