Model Number DS-TV45X45-12F-080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Pseudoaneurysm (2605); Pericardial Effusion (3271)
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Event Date 03/12/2021 |
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 a subsequent submission.
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Event Description
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On (b)(6) 2021, a 22mm amplatzer amulet was implanted using a 12f amulet delivery sheath.On (b)(6) 2021, a small false bulge of the femoral artery up to 2cm in size was "half thrombosed" and an additional av fistula at the level of the femoral vessels was observed.Therefore, the patient underwent vascular revision.No patient consequences were reported.Clinical study patient id: (b)(6).
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Event Description
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On (b)(6) 2021, a 22mm amplatzer amulet was implanted using a 12f amulet delivery sheath.On 12 march 2021, a small false bulge of the femoral artery up to 2cm in size was "half thrombosed" and an additional av fistula at the level of the femoral vessels was observed.Therefore, the patient underwent vascular revision.No patient consequences were reported.Additional information received on 2 april 2021 reported that on (b)(6) 2021, a small hemodynamically insignificant circular pericardial effusion and pericardial fat were observed.Additional information received on 12 april 2021 reported that on (b)(6) 2021, a stationary 4mm pericardial effusion was observed at the right ventricle, however no treatment was required.Clinical study patient id: (b)(6).
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Manufacturer Narrative
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An event of a small false bulge of the femoral artery and an additional av fistula 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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Search Alerts/Recalls
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