Model Number 505D |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Dyspnea (1816); Fatigue (1849)
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Event Date 09/21/2016 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.If the product and/or additional information is received, a supplemental report will be submitted.
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Event Description
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Medtronic received information that approximately three years post implant of this mechanical valve, it was explanted and replaced due to increased gradients measuring 33 mmhg.The patient was symptomatic with dyspnea, chest pain, and fatigue.It was reported that upon explant the valve was functioning as intended and looked normal in appearance.No other adverse patient effects were reported.
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Manufacturer Narrative
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Correction: field "desc evt problem" has been updated.
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Event Description
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Medtronic received information that 3 years post implant of this mechanical valve, it was explanted and replaced due to increased gradients measuring 33 mmhg.The patient was symptomatic with dyspnea, chest pain, and fatigue.It was reported that upon explant the valve was functioning as intended and looked normal in appearance.It is believed that there is a patient prosthesis issue with the valve; therefore, the physician has elected to replace the device.No other adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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