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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
Obstruction/Occlusion (2422)
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Event Date 10/05/2022 |
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 4mm x 4mm amplatzer piccolo occluder was chosen for implant into a patent ductus arteriosus (pda) using an amplatzer torqvue lp delivery system.The dimensions of the defect were measured as 3.6mm x 4.9mm x 12.2mm.The sizing of the piccolo occluder was determined via angiography with measurement on the phillips system.Multiple catheters and wires were required to access the pda, but none of those devices used for initially crossing the defect were abbott products.The occluder was implanted into the pda, and upon release from the cable, the device embolized into the right pulmonary artery (rpa).This was determined by visualization of the device in the rpa under fluoroscopy.The device was retrieved using a transcatheter snare and removed from the patient.The operator believes the cause of the embolization was incorrect sizing of the device and position.The patient was reported as stable upon discharge from the hospital.
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Manufacturer Narrative
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Additional information: d10, h6 - adverse event problem: added code 2017 medical device problem code.An event of device embolized into the right pulmonary artery was reported.A returned device 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 potentially be related to the user not following the recommended sizing chart provided in the ifu.Please note that per the instructions for use, artmt600061587 version c, "warnings: accurate measurements of the ductus are crucial for correct occluder size selection" and "do an aortic angiogram or evaluate device position with echocardiography.Make sure the occluder is in the correct position.Make sure the occluder is stable.Make sure the occluder shape is correct.Measure occlusion of the pda and assess whether there is a residual shunt.".
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Event Description
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N/a.
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Search Alerts/Recalls
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