Catalog Number 9-PFO-035 |
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 03/16/2024 |
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 on 16 march 2024, a 30mm amplatzer pfo occluder was chosen for implant using a 10f amplatzer trevisio intravascular delivery system.During device preparation, there were slight weaves of thread coming off the device.Both the device and delivery system were exchanged.A 35mm amplatzer pfo occluder was chosen for implant.During procedure, the first disc of the device deployed well.Subsequently, there was a disc bulging formation after the second disc was deployed.The device continuously showed bulging after wiggling and light tugging.The device was recaptured and removed from the patient.There was no interaction with cardiac structures and no angulation or kink in the delivery system.Outside of the patient, the device was unable to regain its expected shape.A new 35mm amplatzer pfo occluder was successfully implanted.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported as stable.
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Manufacturer Narrative
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An event of bulging of disc upon deployment was reported.It was also reported that the device was unable to regain its expected shape outside patient.The device was returned to abbott for investigation and the device met visual and functional 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 defined manufacturing specifications.One image from field appeared to show bulbously deployed proximal disc of an occluder device when connected to the delivery cable outside patient.There appeared blood like substance on the distal disc of device.The cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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Event Description
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It was reported that on (b)(6) 2024, a 30mm amplatzer pfo occluder was chosen for implant using a 10f amplatzer trevisio intravascular delivery system.During device preparation, there were slight weaves of thread coming off the device.Both the device and delivery system were exchanged.A 35mm amplatzer pfo occluder was chosen for implant.During procedure, the first disc of the device deployed well.Subsequently, there was a disc bulging formation after the second disc was deployed.The device continuously showed bulging after wiggling and light tugging.The device was recaptured and removed from the patient.There was no interaction with cardiac structures and no angulation or kink in the delivery system.Outside of the patient, the device was unable to regain its expected shape.A new 35mm amplatzer pfo occluder was successfully implanted.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported as stable.
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Search Alerts/Recalls
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