The healthcare professional reported that before the procedure, the physician found that the distal tip of the delivery wire of the 4.5mm x 14mm enterprise® vascular reconstruction device (vrd) (enc451412 / 8219120) broke into two pieces.The device was not used in the patient.A new stent was used for the procedure.There was no negative patient impact.A video of the device was included in the complaint.On 17-nov-2023, additional information was received.Per the information, the delivery wire was not reshaped prior to use.The replacement sent was another 4.5mm x 14mm enterprise vascular reconstruction device (enc451412).There was no clinically significant delay in the procedure as a result of the reported issue.
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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The product analysis team reviewed the attached video of the device.The review is documented below.[video review]: one video was attached to the complaint file in which it was noted that the delivery system was separated leaving the stent inside of the distal portion of the introducer tube.No other damages were noted in the device.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 8219120.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.The issue regarding a stent being prematurely detached was based on the detached condition of the stent.This investigation was performed based only on the video provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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