Model Number 828814PL |
Device Problem
Insufficient Information (3190)
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Patient Problem
Failure of Implant (1924)
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Event Date 04/28/2022 |
Event Type
Injury
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Event Description
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This is 2 of 4 reports linked to mfg report numbers: 3013886523-2022-00208, 3013886523-2022-00215 and 3013886523-2022-00216.A physician reported a certas valve (id 828814pl) was implanted in the right side of a (b)(6) patient on (b)(6) 2022.The initial settings were fine when the physician took over the care, however, ventricle later collapsed.Then another certas valve (id 828814pl) was implanted in the left side on (b)(6) 2022, however, the valve was not performing as it should.Therefore, both valves were explanted on unknown date.On (b)(6) 2022 two additional certas valve (id 828814pl) were implanted which also not up to performance.Based on information provided, the patient is not doing well.
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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The certas valve (id 828814pl) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to a biological debris and protein build up interfering with the valve mechanism.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed..
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Event Description
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N/a.
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Search Alerts/Recalls
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