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Catalog Number E100-31M |
Device Problem
Degraded (1153)
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Patient Problem
Heart Failure/Congestive Heart Failure (4446)
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Event Date 09/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on (b)(6) 2015, a 31mm stented porcine,mit,epic was implanted in a patient.On the day (b)(6) 2023, the heart team of the hospital reviewed their diagnostic reports and acknowledged that the patient was suffering for mitral bioprosthesis dysfunction which resulted in severe heart failure and increased antegrade gradient.On (b)(6) 2023, the patient underwent a percutaneous valve in valve procedure that ended well.The patient is stable.
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Event Description
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It was reported that on (b)(6) 2015, a 31mm stented porcine,mit,epic was implanted in a patient.On the day 05 september 2023, the heart team of the hospital reviewed their diagnostic reports and acknowledged that the patient was suffering for mitral bioprosthesis dysfunction which resulted in severe heart failure and increased antegrade gradient.On (b)(6) 2023, the patient underwent a percutaneous valve in valve procedure that ended well.The patient is stable.
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Manufacturer Narrative
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An event of patient suffering from mitral bio-prosthesis dysfunction that resulted in severe heart failure and increased antegrade gradient after 8 years of implant was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.No implant related factors could be confirmed from the information received from the field as information related to implant procedure was not provided.The device history record was also 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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Search Alerts/Recalls
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