Model Number 21AJ-501 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Aortic Regurgitation (1716); No Consequences Or Impact To Patient (2199)
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Event Date 09/10/2018 |
Event Type
Injury
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Event Description
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On (b)(6) 2018, a 21mm masters valve was implanted in the aortic position.Three months post surgery during a follow-up visit, the patient was confirmed to have severe regurgitation.The physician believed the 21mm valve was inappropriate size for the patient.On (b)(6) 2018, the device was explanted.The patient had elevated differential pressure gradient across the valve during the explant procedure and was administered warfarin to stabilize.The device was successfully replaced with a 23mm masters valve.The patient is reported to be stable.
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Event Description
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It was initially reported that the reported valve was explanted after an implant period of about 3 months.Based on a follow-up conversation with the physician, it was confirmed that this 21mm masters valve was selected for implant, but determined to be the incorrect size so the device was exchanged to complete the procedure.The device was never implanted in the patient.
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Manufacturer Narrative
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An event that the physician chose the improper valve size and did not implant the valve was reported.No damage or other anomalies were found on the valve and there was no evidence of implant, consistent with information from the field.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the mis-sizing event could not be conclusively determined.
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Search Alerts/Recalls
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