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Catalog Number MOM0130069X6 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Numbness (2415)
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Event Date 07/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician used a 9fr mo.Ma ultra during a procedure to treat a soft tissue and plaque lesion in the patent¿s mid right internal carotid artery.Moderate vessel tortuosity was reported.A 0.035 guidewire was used for the external carotid artery, and a 0.14 wire for the internal carotid artery.Vessel pre-dilation was not performed.A non-medtronic stent was placed, and post-dilation of the stent was performed.The mo.Ma was removed from the patient and no procedural issues were reported.There was no complications or issues during the procedure.The patient was feeling ok post procedure.The following day the patient began to experience numbness in the left hand.An mri was performed 3 days post procedure which confirmed a stroke.The physician does not feel the mo.Ma contributed to the stroke event.No further injury reported.
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Manufacturer Narrative
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Image review: a link to 20 dicom image files from the procedure was received and reviewed.The images from the cine folders were arrange chronologically.The first image is of the placement of the introducer sheath and guide wire into the femoral artery access site.The second through fifth cine images are from contrast flow studies of the targeted vessel anatomy from different angels prior to treatment.The sixth and seventh cine images are of the moma device being placed in the vessel anatomy to be treated.The eighth cine image is of the moma device in position and the distal balloon being properly inflated.In the ninth image both moma device balloons were inflated.The tenth and eleventh images both moma device balloons are inflated and a contrast flow study of the targeted vessel anatomy is being conducted.In the twelfth and thirteenth images the stent has been implanted and is being post-dilated with a pta balloon catheter.Both moma device balloons are inflated.The fourteenth image the stent has been implanted, the pta balloon catheter has been removed, and the moma device balloons have been successfully deflated.In the fifteenth and sixteenth images are of contrast flow studies after the stent implant.The seventeenth and eighteenth images are of the moma device in the process of being removed.The nineteenth image is of the femoral artery access site.The twentieth image is of procedure summary.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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Additional information: it is unknown if the stroke has been related to the mo.Ma device or the signs of the stroke appeared due to a plaque penetration through the stent during the post procedural period.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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