Model Number 11500A |
Device Problems
Nonstandard Device (1420); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional manufacturer narrative: the subject device is not available for evaluation.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Event Description
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Edwards received notification that this inspiris resilia valve model 11500a23 was found to have "an abnormal thread".As reported, "there was a detachment of the dacron (polyester) knit at the level of the prosthesis valve." reportedly, the valve was not used.The issue was observed at the sewing of the 2.0 ticron stitches.No other information was provided.
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Manufacturer Narrative
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H10: additional manufacturer narrative: the device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.The root cause of the reported loose thread is related to the design of the product/stent assembly.The root cause is not related to the valve implant procedure or a manufacturing non-conformance.Updated d4, h4, h6.
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Manufacturer Narrative
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H10: additional manufacturer narrative: updated b5.H11: corrected data: based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.
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Event Description
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Edwards received notification that this inspiris resilia valve model 11500a23 was found to have "an abnormal thread".As reported, "there was a detachment of the dacron (polyester) knit of one single stitch at the level of the prosthesis valve." reportedly, the valve was not used.The issue was observed at the sewing of the 2.0 ticron stitches.In this case the loose thread was discovered prior to implant and the valve was not used.The device was returned for evaluation.Customer report of loose thread was confirmed.As received, a long white thread, approximately 83mm long, was found extending from the sewing ring around leaflet 2 near commissure 2 on the outflow aspect.The loose white thread was pulled during evaluation and would not come detached from the sewing ring.
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Event Description
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Edwards received notification that this inspiris resilia valve model 11500a23 was found to have "an abnormal thread".As reported, "there was a detachment of the dacron (polyester) knit of one single stitch at the level of the prosthesis valve." reportedly, the valve was not used.The issue was observed at the sewing of the 2.0 ticron stitches.The device was returned for evaluation.Customer report of loose thread was confirmed.As received, a long white thread, approximately 83mm long, was found extending from the sewing ring around leaflet 2 near commissure 2 on the outflow aspect.The loose white thread was pulled during evaluation and would not come detached from the sewing ring.
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Manufacturer Narrative
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H10: additional manufacturer narrative: updated b5.
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Search Alerts/Recalls
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