H10: 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.The stent was noted to be dislodged from the balloon.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.H10: d4: (expiration date: 02/2025).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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