Model Number 9-VSD-MUSC-016 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2022 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2022, a 16 mm amplatzer muscular vsd occluder was selected for implant.During the implant procedure, while the device was being deployed, it presented in a deformed shape.The device was not implanted.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is stable.No additional information was provided.
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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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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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It was reported that on (b)(6) 2022, a 16 mm amplatzer muscular vsd occluder was selected for implant.During the implant procedure, while the device was being deployed, it presented in a deformed shape.The device was not implanted.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is stable.No additional information was provided.
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Manufacturer Narrative
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The reported event of the device deploying deformed could not be confirmed.The investigation confirmed the device met visual 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 incident could not be conclusively determined.
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Search Alerts/Recalls
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