Catalog Number 9-AVP038-004 |
Device Problem
Difficult to Fold, Unfold or Collapse (1254)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
Event Type
malfunction
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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 a 4mm amplatzer vascular plug iv was selected for implant on 05 (b)(6) 2023 to treat cardiac malformation.During implant, the device took on a deformed shape, with the distal part of the plug wider than the proximal part.It was observed the second lobe was unable to deploy.The device was removed from the patient prior to release from the delivery system.It was noted that the device was replaced with a new unknown device.The intervention time was reported to be less than 30 minutes.There was no adverse effects to the patient.
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Manufacturer Narrative
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An event of device deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional and visual specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.No other complaints were reported on the batch.The cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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