Catalog Number 9-VSDMUSCPI-024 |
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 12/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An event of the device deforming cobra during the implant procedure was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A returned device assessment could not be performed as the device was not returned for analysis.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.Information from the field indicated that the correct size delivery sheath was used and that there was no anatomical interference or angulation or kink in the delivery system.The root cause of the reported event could not be conclusively determined.
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Event Description
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It was reported that on (b)(6) 2023, a 24mm amplatzer post-infarct muscular vsd occluder was chosen for implant using a 10f amplatzer trevisio intravascular delivery system.During procedure, the left ventricular disc had a cobra deformation.The device was recaptured and replaced with a new 24mm amplatzer post-infarct muscular vsd occluder.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.The replacement device was successfully implanted with no adverse health consequences.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure.The patient was reported stable.
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Search Alerts/Recalls
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