Model Number 9-PDA2-06-06 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Embolism (1829); Foreign Body Embolism (4439)
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Event Date 11/04/2020 |
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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On (b)(6) 2020, a 6/6 amplatzer duct occluder ii was selected based on measurements of the ductal anatomy for implant in the patient.During the procedure the device was positioned, released from the delivery cable and then embolized into the patient's pulmonary trunk.The device was retrieved using a merit medical snare.The patient did not experience any serious injuries and a 6mm amplatzer duct occluder(ado) was used in replacement since the ductus was too lax.The ado device was successfully implanted in the patient.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure.The patient is currently stable.
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Manufacturer Narrative
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An event of the device embolizing into the patient's pulmonary trunk was reported.The investigation confirmed the device met dimensional 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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