Model Number AVSM10040 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Aneurysm (1708); Restenosis (4576)
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Event Date 05/13/2021 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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Event Description
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It was reported through the results of a clinical trial, that approximately three months and one day post index procedure, the subject developed seventy percent of stenosis.Standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.After four months and seventeen days post study device implantation, the patient was diagnosed with aneurysm and standard percutaneous transluminal angioplasty (pta) was used for treatment.The current patient status is not provided.
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Manufacturer Narrative
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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: neither sample nor images provided which leads to inconclusive evaluation result.There were no reported issues with the delivery system; the stent was successfully placed without periprocedural complication.Pre- and post-dilation were performed upon index procedure.Based on the provided information, the investigation is closed as inconclusive.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Based on the instructions for use complications and adverse events associated with the use of the covera vascular covered stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes restenosis of the target vessel.Regarding pre and post dilation the instructions for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated" and "post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.Avoid balloon dilation in the healthy, non-stenosed segment of the vessel." holding and handling for regular deployment was found described.H10: d4 (expiry date: 10/2022), g3.H11: h6 (method).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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Event Description
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It was reported through the results of a clinical trial, that approximately three months and one day post index procedure, the subject developed seventy percent of stenosis.Standard percutaneous transluminal angioplasty (pta) was used to successfully treat the target lesion.After four months and seventeen days post study device implantation, the patient was diagnosed with aneurysm and standard percutaneous transluminal angioplasty (pta) was used for treatment.The current patient status is not provided.
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Search Alerts/Recalls
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