Model Number 27MJ-501 |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/21/2019 |
Event Type
Injury
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Event Description
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On (b)(6) 2019, a 27mm masters valve was selected for implant.While testing the valve after implantation, a metallic piece was observed to be detached.The valve was explanted and replaced with another 27mm masters valve (serial number: unknown).The procedure was extended 30 minutes.Additional information is requested.
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Manufacturer Narrative
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The reported event of a dislodged leaflet was confirmed.One leaflet had dislodged from the orifice and was returned reinserted.There was chipping on two butterfly pivot areas.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 leaflet dislodgement and damage could not be conclusively determined; however, it was consistent with some external force applied to the leaflet and orifice, which overstressed the carbon material and resulted in the damage.
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Event Description
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On (b)(6) 2019, a 27mm masters valve was selected for implant.After implantation, the valve was tested with a leaflet tester and a leaflet was observed to be detached.The valve was explanted and replaced with another 27mm masters valve (serial number: unknown) and no patient consequences were reported.Per site, the procedure and cardiac pump time were extended 30 minutes.
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Event Description
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On (b)(6) 2019, a 27mm masters valve was selected for implant.After implantation, the valve was tested with the valve holder and a leaflet was observed to be detached.The valve was explanted and replaced with another 27mm masters valve (serial number: unknown) and no patient consequences were reported.Per site, the procedure and cardiac pump time were extended 30 minutes.
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Search Alerts/Recalls
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