Catalog Number 9-ASD-MF-030 |
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 11/21/2023 |
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 30mm amplatzer cribiform occluder was selected for implant on (b)(6) 2023 using a 9f amplatzer trevisio intravascular delivery system.During implant both discs of the device took a bulging shape.The operator attempted to push and pull the device to reposition the device and waited one minute for the discs to return to their original shape.The device was removed and another attempt was made to deploy the device.Both discs of device remained deformed.The operator made another attempt to push and pull the device to reposition it and waited one minute for the discs to return to their original shape.The discs did not return to their original shape.The device was removed from the patient and replaced with a new 30-25mm amplatzer talisman pfo occluder.There were no interactions with cardiac structures nor were there any angulations or kinks noted on the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.
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Manufacturer Narrative
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An event of device deformity 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 not conclusively be determined but could have been as a result of the use of a larger than recommended delivery system as the use of a larger sheath may influence deformations.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that the recommended size delivery system for a 9-asd-mf-030 per the instructions for use is an 8f.
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Search Alerts/Recalls
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