As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, an image is provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2022).
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H10: manufacturing review: 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 evaluation of the returned sample, and images provided confirmed that the user experienced an expansion issue with the stent during deployment.Shifting of the inner catheter stent brake on the returned sample, and hourglass like deformation near the stent brake section indicated that the stent adhered to the stent brake during deployment, leading to expansion issue.As reported, the stent did finally expand successfully after a few minutes.Malposition could not be confirmed based on the image provided.A definite root cause for the reported event could not be determined.Labeling review: a review of the relevant for this product was conducted.The instruction for use was found to address potential complications and adverse events such as incorrect positioning of the stent requiring further stenting or surgery, intimal injury, and malposition.H10: d4 (expiry date: 07/2022).H11: h6 (results).H11: section a through f: the information provided by bd represents all of 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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