MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL MECHANICAL VALVE; HEART-VALVE, MECHANICAL
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Model Number MDT-MECH VALVE |
Device Problems
Degraded (1153); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)
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Patient Problems
Endocarditis (1834); Valvular Insufficiency/ Regurgitation (4449)
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Event Date 05/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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Citation: feier h, grigorescu a, falnita l, rachita o, gaspar m, luca ct.Long-term results (up to 20 years) of 19 mm or smaller prostheses in the aortic position.Does size matter? a propensity-matched survival analysis.Journal of clinical medicine.2021; 10(10):2055.Https://doi.Org/10.3390/jcm10102055.Earliest date of publish used for date of event.Medtronic products referenced: (b)(4).Earliest approved product used for product code and pma#.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information via literature regarding long-term outcomes of small prosthesis implantation in the aortic position.All data were collected from a single center between 2000 and 2018.The study population included 670 patients (predominantly female, mean age 65years).Medtronic valves that were implanted include: open pivot (37), med hall (11), advantage (4), hancock ii (74), and freestyle (6).The remaining patients were implanted with a non-medtronic valve.No serial numbers were provided.Among all patients, no deaths were attributed to a medtronic device.Among all patients, adverse events included: patient-prosthesis mismatch (ppm), valve degeneration.Other adverse events included endocarditis and severe paravalvular leak (pvl) treated with reoperation.Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.
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