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Model Number 9-PDAP-05-02-L |
Device Problems
Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Foreign Body Embolism (4439)
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Event Date 03/26/2021 |
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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On (b)(6) 2021, a 5/2 amplatzer piccolo occluder was selected for implant in a (b)(6) month old, (b)(6) kg patient with the following patent ductus arteriosus(pda) dimensions: aortic end 6.6mm, pulmonary artery end of 4.3mm with the narrowest portion measuring at 3.3mm and a length of 9.5mm.The device was placed intraductal in an acceptable position and released.The device then migrated to the right pulmonary artery(rpa).The device was snared without incident and there was no patient injuries.Multiple other devices were attempted (6mm amplatzer vascular plug ii, 8mm amplatzer vascular plug ii and mvp &q) but none were released from the delivery cable and none were implanted in the patient.There was no clinically significant delay to the procedure.The procedure was aborted, the patient is currently recovering and is scheduled for surgical closure.
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Manufacturer Narrative
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An event of device embolism was reported.The investigation confirmed the device met functional and 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 at the time of commercialization.The cause of the reported incident could not be conclusively determined.A capa was initiated for further investigation on the device embolization, per internal procedures.Please note per the instruction for use, arten600042307 version b, sizing chart t2, the recommended size devices for patients >2kg have a maximum duct length of 8mm, and therefore the 9.5mm pda of the reported event falls outside recommended sizing.
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Search Alerts/Recalls
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