During implant of a 30mm amplatzer cribriform occluder (aco, lot 5556170), the device could not be advanced through an 8f amplatzer torqvue 45 delivery system (dtv45) sheath.The dtv45 was replaced and a new dtv45 was used to deploy the original aco; however, the aco deformed mushroom-shaped in the left atrium.The aco was removed and a second 30mm aco (lot 5658352) was implanted and released; however, post-release the 30mm aco was found to be too small and was snared and removed.A 35mm aco was implanted successfully using a new delivery system.
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(b)(4).The results of this investigation confirmed the amplatzer cribriform occluder met all functional and dimensional specifications when analyzed at sjm.A review of the device history record confirmed the occluder met all visual, dimensional, and functional specifications at the time it was manufactured, prior to shipment.There was no evidence to suggest there was an intrinsic defect in the occluder, and the cause for the reported event remains unknown.
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