Model Number 9-ASD-010 |
Device Problem
Material Deformation (2976)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
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Event Description
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The patient previously underwent a mitraclip procedure.During triclip procedure on (b)(6) 2020, an atrial septum defect was observed and was suspected to be due to the previous mitraclip procedure.Tee assessment showed shunt, so the decision was made to implant a 10mm amplatzer occluder.During the implant, it was observed that the asd did not unfolded as intended.When deployed the asd took on a cobra shape.The physician attempted to unfold the device 4 to 5 times but the occluder did not unfold as intended.The device was removed and replaced with another occluder.The atrial septum defect was successfully treated and no residual shunt.Patient was reported in stable condition.
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Manufacturer Narrative
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An event of the device deforming upon deployment and it being depolyed 4 to 5 times was reported.A more comprehensive 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 be conclusively determined.Please note, per the instructions for use, artmt 600034451 revision c, "caution: do not release the device from the delivery cable if the device does not conform to its original configuration or if device position is unstable or interferes with any adjacent cardiac structure (such as svc, pv, mv, cs, ao).Advance the delivery sheath to recapture the device and redeploy.If the device position is still unsatisfactory, recapture the device and replace it with a new device or abort the procedure.".
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Manufacturer Narrative
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The reported event of device deformity upon deployment not be confirmed.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.Please note, per the instructions for use, artmt 600034451 revision c, "caution: do not release the device from the delivery cable if the device does not conform to its original configuration or if device position is unstable or interferes with any adjacent cardiac structure (such as svc, pv, mv, cs, ao).Advance the delivery sheath to recapture the device and redeploy.If the device position is still unsatisfactory, recapture the device and replace it with a new device or abort the procedure.".
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Search Alerts/Recalls
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