Model Number 9-VSDMUSCPI-022 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
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Event Description
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A 22mm vsd device was deployed during a post-infarct vsd case.Whilst attached to the delivery cable the deployed device took on a misshapen appearance.The device was recaptured and removed from the patient without consequence.A new 24mm device was implanted without further incident to the patient.
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Manufacturer Narrative
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The reported event of the device deforming in a "misshapen appearance" could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.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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