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Model Number 9-PDAP-04-02-L |
Device Problems
Migration or Expulsion of Device (1395); Obstruction of Flow (2423)
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Patient Problems
Pulmonary Dysfunction (2019); Renal Failure (2041); Obstruction/Occlusion (2422); Foreign Body Embolism (4439)
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Event Date 05/11/2021 |
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 the final report.
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Event Description
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It was reported that on (b)(6) 2021, a 4/2 amplatzer piccolo occluder was selected for implant in a (b)(6) day old (b)(6) kg patient that was critically ill with respiratory failure and renal insufficiency.The patient had the following patent ductus arteriosus (pda) dimensions: pda minimal diameter of 2.4mm, pda length of 8.2mm and diameter at aortic ampulla of 3.3mm.During the procedure the device was successfully placed intraductally near the aortic end of the pda without impingement on the pulmonary artery (pa) or aorta.5 days post implant, the patient presented with symptomatic aortic obstruction, left ventricle (lv) dysfunction, and renal failure.The patient was taken back to the cath lab and it was found that the device had migrated such that the aortic disc and part of central disc were pushing into aorta, not allowing for the use of a stent.The device couldn't be removed or coarctation stented by transcatheter approach, so device was removed surgically.The pda was ligated and the aorta repaired.No residual pda or coarctation was noted by echo post pda device removal.The patient is recovering but is critically ill, as they were prior to the procedure.No additional information was provided.
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Manufacturer Narrative
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An event of migration of device 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.A capa was initiated for further investigation into complaints regarding embolization and migration of piccolo occluder, per internal procedures.
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Search Alerts/Recalls
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