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Model Number OCCLUDER |
Device Problems
Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on (b)(6) 2022, a 4/6 amplatzer piccolo was successfully implanted in a (b)(6), (b)(6) patient in the intraductal position.The patient had the following patent ductus arteriosus (pda) dimensions: pda minimal diameter of 1.9 mm, pda length of 10-12 mm and diameter at aortic ampulla of 5.3 mm.Overnight, the device had became embolized and traveled into the distal left pulmonary artery (lpa).In an emergency procedure on (b)(6) 2022, the device was removed via transcatheter snare to resolve the event.The patient remained hemodynamically stable throughout and is currently stable.The physician alleges the cause of the event to be due to the device being undersized.It was unknown if the device was replaced.
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Manufacturer Narrative
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An event of embolism of a 4/6mm piccolo device was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.A review of the measurements as reported from the field was performed.Per the sizing table in the instructions for use, the duct was longer than the sizing chart included for patients larger than 2ks, measuring at 11mm, and that the device diameter selected (4mm) was larger than recommended for a minimal ductus diameter of 1.9mm (3mm).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.There is no indication of a product quality issue with regards to manufacture design or labeling.
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Search Alerts/Recalls
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