Model Number 305U |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Anemia (1706); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262)
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Event Date 12/02/2015 |
Event Type
Injury
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Manufacturer Narrative
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Conclusion: per the device instructions for use (ifu), acute blood loss is a known potential adverse effect commonly resolved through a blood transfusion.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.The reported information does not indicate a potential manufacturing issue.(b)(4).
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Event Description
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Medtronic received information that following implant of this bioprosthetic valve, cardiogenic shock was noted; medication was prescribed to treat hypotension.Acute blood loss anemia was also noted.The patient was returned to the operating room for a mediastinal hematoma evacuation, during which time 1 unit of packed red blood cells (prbcs) were transfused intraoperatively.The hematoma and cardiogenic shock resolved 1 day post-implant.No further 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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