Catalog Number 9-PFO-2518 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
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Event Date 03/08/2024 |
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: crd_806 - pfo occluder pas, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 25-18mm amplatzer talisman pfo occluder was chosen for a procedure using a 8f amplatzer trevisio intravascular delivery system.The occluder was implanted without any difficulty.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.About 2 hours after the procedure, patient complained about pain in the chest/epigastric region and vomited the food they just had.The patient felt better after that but there was a decreased heart rate of ~47-50s with systolic blood pressure of 60mm hg.A 0.5mg of atropine was given via intravenous (iv).A 12-lead electrocardiogram (ekg) was performed, which cane back normal.The physician mentioned the cause of this event was related to the procedure.The patient was repotted discharged same day.
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Manufacturer Narrative
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An event of chest pain and vomiting after two hours of procedure and decreased heart rate was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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Event Description
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Clinical information: crd_806 - pfo occluder pas, patient site id: (b)(6) ((b)(4)).It was reported that on (b)(6) 2024, a 25-18mm amplatzer talisman pfo occluder was chosen for a procedure using a 8f amplatzer trevisio intravascular delivery system.The occluder was implanted without any difficulty.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.About 2 hours after the procedure, patient complained about pain in the chest/epigastric region and vomited the food they just had.The patient felt better after that but there was a decreased heart rate of ~47-50s with systolic blood pressure of 60mm hg.A 0.5mg of atropine was given via intravenous (iv).A 12-lead electrocardiogram (ekg) was performed, which cane back normal.The physician mentioned the cause of this event was related to the procedure.The patient was repotted discharged same day.
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Search Alerts/Recalls
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