Model Number 11060A27 |
Device Problems
Fluid/Blood Leak (1250); Gradient Increase (1270); Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Thrombocytopenia (4431); Thrombosis/Thrombus (4440); Insufficient Information (4580)
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Event Date 12/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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Event Description
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It was reported that a 27mm 11060a after an implant duration of 2 - 3 weeks has the noncoronary leaflet which is not functioning properly and is fixing in a partially open position creating stenosis and regurgitation.The patient is scheduled to undergo a valve-in-valve procedure on (b)(6) 2024.
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Manufacturer Narrative
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H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.
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Event Description
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It was reported that a 27mm 11060a underwent a valve-in-valve procedure after an implant duration of 28 days due to leaflet not functioning properly, stenosis, insufficiency, and thrombus caused by non-edwards device with hit.The tavr was performed with an 26mm 9755rsl transcatheter valve.Patient initially underwent aortic root replacement with 27mm konect with impella placement on (b)(6) 2023.Echo showed noncoronary leaflet is not functioning properly and surgeon suspected it was because of the impella device.The patient developed hit and was placed on argotroban.The impella was removed complicated by bleeding.Medical records showed on tee both narrowing and insufficiency of the bioprosthetic valve related to partial thrombosis in the setting of hit, with at least two of the three leaflets with restricted motion positioned adjacent to the native rcc and lcc.The patient was deemed a poor surgical candidate; therefore, a valve-in-valve was performed with a 26mm s3ur.Tee post implant of transcatheter valve showed good valve positioning and no perivalvular leak.The patient left the cticu in stable condition.
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Manufacturer Narrative
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The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Thrombosis is a well-recognized complication of prosthetic devices.Device thrombosis is the formation of blood clots on the device/graft.There may be cases of incidental finding by imaging (ct scan) of thicken leaflets (halt) when the patient will benefit from a close follow-up and may be treated with oral anticoagulant.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.The most likely cause is due to another device.
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Event Description
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It was reported through the patient support center, that a 27mm 11060a underwent a valve-in-valve procedure after an implant duration of 28 days due to leaflet not functioning properly, stenosis, insufficiency, and thrombus caused by non-edwards device with hit.The tavr was performed with an 26mm 9755rsl transcatheter valve.Patient initially underwent aortic root replacement with 27mm konect with impella placement on (b)(6) 2023.Echo showed noncoronary leaflet is not functioning properly and surgeon suspected it was because of the impella device.The patient developed hit and was placed on argotroban.On (b)(6) 2023 impella was removed complicated by bleeding.Tee showed both narrowing and insufficiency of the bioprosthetic valve related to partial thrombosis in the setting of hit, with at least two of the three leaflets with restricted motion positioned adjacent to the native rcc and lcc.The patient was deemed a poor surgical candidate.On (b)(6) 2024, a valve-in-valve was performed with a 26mm s3ur.Tee post implant of transcatheter valve showed good valve positioning and no perivalvular leak.The patient left the cticu in stable condition.On pod #44, the patient was discharged home.
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Search Alerts/Recalls
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