Model Number 9-ATV08F45/80 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)
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Event Date 03/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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The results, method, and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Clinical study patient id: (b)(6).On (b)(6) 2021, a 25 mm amplatzer pfo occluder was successfully implanted with no issues.On (b)(6) 2021, the patient complained of right groin pain.Ultrasound imaging was performed near the access site and revealed femoral vein thrombosis in the right common femoral vein (cfv) and arteriovenous (av) fistulas in the common femoral artery/common femoral vein (cfa/cfv).Medication was administered to treat the thrombosis while the fistula was monitored.On (b)(6) 2021, imaging performed showed no fistula, but revealed a pseudoaneurysm.The patient was referred to vascular for monitoring.On (b)(6) 2021, imaging performed shoed no evidence of deep vein thrombosis.The patient is stable.There are no allegations of malfunction against the pfo or the delivery system.
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Manufacturer Narrative
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An event of thrombus in the right common femoral vein, arteriovenous fistula in the common femoral vein and a pseudoaneurysm was reported.A more comprehensive assessment could not be performed as the device 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 information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Additional information received indicates that on (b)(6) 2021, the patient presented for a follow-up and showed no evidence of a pseudoaneurysm.
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Manufacturer Narrative
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Additional information: b5.
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Search Alerts/Recalls
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