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Manufacturer¿s ref.(b)(4).Initial reporter phone: (b)(6).[conclusion]: the healthcare professional reported that during a stent-assisted coil embolization targeting a basilar aneurysm, after coil implantation, the physician implanted a 4 mm x 39 mm enterprise®2 stent (encr403912 / 7014935) in the target position.After the procedure was completed, the patient remained comatose and unconscious.Angiography was performed confirming that the markers on the distal and proximal ends of the stent converged, were not opened well and the patient¿s vessel was occluded.A solitaire stent retriever (medtronic) was implanted after balloon dilation and the procedure was completed.The procedure was prolonged for approximately three (3) hours.The patient is reported to be in stable condition.No additional information is currently available.On 04-aug-2022, the cerenovus sales representative confirmed the following information: the stent-assisted coil embolization procedure was performed on the patient who presented with a dissecting aneurysm of the basilar artery.After coil implantation, the physician implanted the stent in the target position.The procedure was considered successfully completed, however, the patient remained comatose and unconscious.Angiography confirmed that the markers on the distal and proximal ends of the stent converged, were not opened fully resulting in the patient¿s vessel becoming occluded.Blood flow was recanalized after balloon dilation and the vessel was observed to be re-occluded after a while.A solitaire stent retriever (medtronic) was implanted after balloon dilation and the procedure was completed.The procedure was prolonged for approximately three (3) hours.The patient is reported to be in stable condition.No additional information is currently available.On 08-aug-2022, additional information was received.The information indicated that the targeted basilar artery aneurysm was an unruptured aneurysm.There were no vessel nor aneurysm factors that may have contributed to the reported incomplete expansion.The patient was in a coma / unconscious state for one week.He has since been discharged from the hospital.His hospitalization was prolonged by approximately three (3) ¿ four (4) days.The information indicated that the temperature indicator label on the inner pouch has been checked and found to be acceptable.There was no resistance during the advancement of the stent.The incomplete expansion did result in the migration of the stent.The microcatheter used was a cerenovus microcatheter, but the catalog and lot number are not available.There was no damage noted on the microcatheter; the same microcatheter was used to deliver the solitaire stent retriever.There are four (4) videos and two (2) images pending review by the senior medical director.A supplemental 3500a report will be submitted once the review has been completed.Based on complaint information, the device remains implanted and is thus not available for evaluation.Lake region medical performed a review of the device history records relative to the manufacturing, inspection, and packaging of the lot 7014935.The history record indicates this product was final inspection tested at lake region medical and was determined to be acceptable.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, the investigation will be closed.Incomplete expansion of the stent could lead to thrombosis and/or migration or embolization, resulting in ischemia or infarct.Per the event description, the patient experienced vessel occlusion due to an incomplete expansion of the markers on the distal and proximal ends of the stent.Migration of the stent could lead to embolization, possibly ischemia or infarct.As a result, the patient remained comatose after the procedure.Consequently, a second non-cerenovus stent was implanted.In addition, the surgery was prolonged for approximately three (3) hours and the hospitalization was prolonged from three (3) to four (4) days.Therefore, this event meets mdr reporting criteria with the classification of ¿serious injury.¿ with the information provided and without the the product available for analysis, the reported issue documented in the complaint related to the incomplete expansion which did result to the migration of the stent could not be confirmed through product evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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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The healthcare professional reported that during a stent-assisted coil embolization targeting a basilar aneurysm, after coil implantation, the physician implanted a 4 mm x 39 mm enterprise®2 stent (encr403912 / 7014935) in the target position.After the procedure was completed, the patient remained comatose and unconscious.Angiography was performed confirming that the markers on the distal and proximal ends of the stent converged, were not opened well and the patient¿s vessel was occluded.A solitaire stent retriever (medtronic) was implanted after balloon dilation and the procedure was completed.The procedure was prolonged for approximately three (3) hours.The patient is reported to be in stable condition.No additional information is currently available.On 04-aug-2022, the cerenovus sales representative confirmed the following information: the stent-assisted coil embolization procedure was performed on the patient who presented with a dissecting aneurysm of the basilar artery.After coil implantation, the physician implanted the stent in the target position.The procedure was considered successfully completed, however, the patient remained comatose and unconscious.Angiography confirmed that the markers on the distal and proximal ends of the stent converged, were not opened fully resulting in the patient¿s vessel becoming occluded.Blood flow was recanalized after balloon dilation and the vessel was observed to be re-occluded after a while.A solitaire stent retriever (medtronic) was implanted after balloon dilation and the procedure was completed.The procedure was prolonged for approximately three (3) hours.The patient is reported to be in stable condition.No additional information is currently available.On 08-aug-2022, additional information was received.The information indicated that the targeted basilar artery aneurysm was an unruptured aneurysm.There were no vessel nor aneurysm factors that may have contributed to the reported incomplete expansion.The patient was in a coma / unconscious state for one week.He has since been discharged from the hospital.His hospitalization was prolonged by approximately three (3) ¿ four (4) days.The information indicated that the temperature indicator label on the inner pouch has been checked and found to be acceptable.There was no resistance during the advancement of the stent.The incomplete expansion did result in the migration of the stent.The microcatheter used was a cerenovus microcatheter, but the catalog and lot number are not available.There was no damage noted on the microcatheter; the same microcatheter was used to deliver the solitaire stent retriever.There are four (4) videos and two (2) images pending review by the senior medical director.
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Manufacturer¿s ref: (b)(4).The purpose of this mdr submission is to include the video and image review by the senior medical director.The four (4) videos and two (2) images were reviewed by dr.(b)(6): cerenovus senior medical affairs director on (b)(6) 2022.The review / assessment is documented below."the history is clear and 4 movies and one still image were provided illustrating the problem encountered.Unfortunately, there is no image of the contrast stagnation that depicts the stent and stent struts with markers.It is therefore not possible to see what the configuration of the stent looked like at the time of the occlusion.The images that are available show both stents being present, and all markers seem to be independently visible in the lumen, suggesting opening at the proximal and distal end of the device.There are several reasons for ¿non-opening¿ or ¿partial opening¿ of endovascular stents, which include but are not limited to: local vasospasm, atherosclerosis, device failure and reflux of blood into the microcatheter prohibiting deployment.Which factor, or combination of factors, that was of influence in this case cannot be reliably deducted from the images." physician name and date reviewed: (b)(6) md, on (b)(6) 2022.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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