Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one valeo device was received for evaluation.During visual evaluation, the stent was noted dislodged proximally on the balloon.No kinks to the catheter, no anomalies to the luers/y-body.During functional testing, the sample guidewire lumen was flushed with an in-house syringe without any issues.The patency of the guidewire lumen was tested using an in-house.035¿ guidewire and was able to insert without issue.Functional testing with the introducer sheath could not be performed due to the condition of the returned device.Therefore, the investigation is inconclusive for the reported sheath insertion difficulty, but confirmed for the reported stent dislodgement, as functional testing using the sheath could not be performed per the conditions of use since the device was received with the stent dislodged from the balloon.A definitive root cause for the alleged sheath insertion difficulty and stent dislodgement could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (expiration date: 10/2024).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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