Model Number 9-AVP2-022 |
Device Problems
Use of Device Problem (1670); Human-Device Interface Problem (2949)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/12/2021 |
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) 2020, a 22mm amplatzer vascular plug ii was selected for implant to occlude a portal vein.The plug was prepared per the ifu and released from the cable.However, post-implant, the plug was observed to occlude the inferior vena cava (ivc).Therefore, the plug was snared and removed from the patient.A new competitor's asd device was successfully implanted.A clinically significant delay in the procedure time was reported.The patient was reported to be in stable condition.
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Manufacturer Narrative
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An event of the plug occluding the inferior vena cava in addition to the target vein 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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Manufacturer Narrative
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An event of plug occluded the inferior vena cava (ivc) was reported.The investigation confirmed the device met dimensional and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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