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Catalog Number 23AGFN-756 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Transient Ischemic Attack (2109); Embolism/Embolus (4438)
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Event Date 12/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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Clinical information: (b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2022, a 23mm sjm regent heart valve with flex cuff was successfully implanted in a patient.The patient had remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.On (b)(6) 2022, the patient underwent a head and neck computed tomography angiogram due to poor muscle strength in the left lower limb.Results indicated a transient ischemic attack in the right frontal area.On (b)(6) 2022, another computed tomography angiogram revealed an embolus.The patient's anticoagulant lipid regulation was continued and a plaque was stabilized.The patient was administered medication.The patient entered rehabilitation and was administered warfarin on (b)(6) 2022.The patient had a needling/acupuncture performed on (b)(6) 2022.On (b)(6) 2022, a craniocerebral computed tomography scan revealed that the infarct had slightly decreased in size.It was also noted that the patient's left lower limb muscle strength improved.On (b)(6) 2022, the patient was discharged.Two weeks post-discharged, it was noted that the patient's left lower limb muscle strength had normalized and the patient could walk normally.It's believed that the patient's stroke is due to an embolus, a brain drip irrigation that was performed during the implant procedure, and the implant procedure itself.There is no allegation of malfunction against the abbott device or procedure.
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Manufacturer Narrative
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An event of stoke and embolism was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the received information, it was noted that the patient's stroke is due to an embolus.There is no allegation of malfunction against the abbott device or procedure.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 health effect - clinical code: code 2109 removed.
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Event Description
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Clinical information: (b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2022, a 23mm sjm regent heart valve with flex cuff was successfully implanted in a patient.The patient had remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.On (b)(6) 2022, the patient underwent a head and neck computed tomography angiogram due to poor muscle strength in the left lower limb.Results indicated a stroke in the right frontal area.On (b)(6) 2022, another computed tomography angiogram revealed an embolus.The patient's anticoagulant lipid regulation was continued and a plaque was stabilized.The patient was administered medication.The patient entered rehabilitation and was administered warfarin on (b)(6) 2022.The patient had a needling/acupuncture performed on (b)(6) 2022.On (b)(6) 2022, a craniocerebral computed tomography scan revealed that the infarct had slightly decreased in size.It was also noted that the patient's left lower limb muscle strength improved.On (b)(6) 2022, the patient was discharged.Two weeks post-discharged, it was noted that the patient's left lower limb muscle strength had normalized and the patient could walk normally.It's believed that the patient's stroke is due to an embolus, a brain drip irrigation that was performed during the implant procedure, and the implant procedure itself.There is no allegation of malfunction against the abbott device or procedure.
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Search Alerts/Recalls
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