Model Number 27MJ-501 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Mitral Regurgitation (1964); Thrombus (2101); No Consequences Or Impact To Patient (2199)
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Event Date 08/30/2018 |
Event Type
Injury
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Event Description
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On (b)(6) 2018, a 27mm masters valve was implanted in the mitral position.During the three month follow-up, the patient was confirmed to have severe regurgitation which required intervention.On (b)(6) 2018, the device was explanted.The patient didn't remain hemodynamically stable throughout the procedure; the cross-valve differential pressure was high.The patient was administered additional warfarin to stabilize.The physician believes the regurgitation was due to the size of the valve.Per the physician there was thrombus on the device.The device was replaced and a 29mm masters valve was implanted.The patient was stable post-operatively.
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Manufacturer Narrative
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An event that the physician chose the improper valve size and while handling the valve before implant the valve fell to the floor 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 and contamination event could not be conclusively determined.
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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 27mm valve was selected for implant, but determined to be the incorrect size.As the device was exchanged the device fell onto the floor.The procedure was completed with a replacement device.The reported device was never implanted in the patient.
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Search Alerts/Recalls
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