Model Number FDS40020 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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Device is implanted in patient.
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Event Description
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It was reported that in a clinical trial procedure, the subject flow diverter was used in the left internal carotid artery-ophthalmic (c6 segment) to treat a saccular aneurysm measuring 8.72mm.10 days post procedure, the patient had visual disturbances (blurred vision and vision loss) in the left eye which were treated by administering clopidogrel.The event was reported as recovered/resolved.The event was reported as possibly related to the subject device by the site.
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Event Description
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It was reported that in a clinical trial procedure, the subject flow diverter was used in the left internal carotid artery-ophthalmic (c6 segment) to treat a saccular aneurysm measuring 8.72mm.10 days post procedure, the patient had visual disturbances (blurred vision and vision loss) in the left eye which were treated by administering clopidogrel.The event was reported as recovered/resolved.The event was reported as possibly related to the subject device by the site.
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Manufacturer Narrative
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H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It was reported that the patient had a saccular aneurysm located in the left internal carotid artery-ophthalmic (c6 segment) measuring 8.72mm.The procedure date for implantation of the stent was (b)(6) 2021 and due to blurred vision in the left eye, clopidogrel 75mg qd was administered on the (b)(6) 2021.The adverse event was resolved.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.
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Event Description
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It was reported that in a clinical trial procedure, the subject flow diverter was used in the left internal carotid artery-ophthalmic (c6 segment) to treat a saccular aneurysm measuring 8.72mm.10 days post procedure, the patient had visual disturbances (blurred vision and vision loss) in the left eye which were treated by administering clopidogrel.The event was reported as recovered/resolved.The event was reported as possibly related to the subject device by the site.
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Manufacturer Narrative
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B1: adverse event/product problem ¿ corrected - no ¿adverse event¿.B2: outcomes attributed to ae - corrected - no ¿none¿.H1: type of reportable event ¿ corrected - no ¿serious injury¿.H2: if follow-up, type: updated.H10; additional mfg narrative type: updated.The adverse event "visual disturbances (blurred vision and vision loss) in the left eye" was previously reported in mfr report # 3008881809-2022-00007.Upon further review, it was confirmed that the subject device was used on the same event date, in the same case, and on the same patient.The second event of "visual disturbances (blurred vision and vision loss) in the left eye" reported for the same patient is investigated under report mfr report # 3008881809-2021-00254.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
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Search Alerts/Recalls
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