Model Number RIGID SADDLE RING |
Device Problem
Material Separation (1562)
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Patient Problems
Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 05/05/2022 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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Clinical information: (b)(4), patient site id: (b)(6).It was reported that on (b)(6) 2021, a 30mm rigid ring saddle was successfully implanted in a patient.On (b)(6) 2022, the patient returned to the hospital due to symptoms of dyspnea.An echocardiogram was performed and discovered ring dehiscence and primary mitral valve regurgitation.There was no signs of progression of the dehiscence.The patient was monitored and given a regimen of heart failure medication.The follow up determine that the patient currently does not require surgical intervention.
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Event Description
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Clinical information: (b)(4) , patient site id: (b)(6).It was reported that on (b)(6) 2021, a 30mm rigid saddle ring was successfully implanted in a patient.On (b)(6) 2022, the patient returned to the hospital due to symptoms of dyspnea.An echocardiogram was performed and discovered ring dehiscence and primary mitral valve regurgitation.There was no signs of progression of the dehiscence.The patient was monitored and given a regimen of heart failure medication.The follow up determine that the patient currently does not require surgical intervention.Subsequent to the previously filed report, additional information was received that the patient had also suffered from a right leg edema and worsening heart failure (new york heart association class ii).The patient mitral insufficiency/regurgitation was of grade 1.The patient had initially been prescribed a regimen of entresto 24/26 twice a day and jardiance 10mg a day.After the onset of dyspnea, ring dehiscence, and mitral regurgitation, the patient was prescribed a regimen of bisoprolol (2.5mg per day) and torasemid (10-15mg per day).There is no other intervention other than the added medication.It is unknown what caused the 30mm rigid saddle ring dehiscence and mitral regurgitation.There was no allegation of malfunction against the 30mm rigid saddle ring or procedure.The patient was stable at the time of report.
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Manufacturer Narrative
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An event of ring dehiscence was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the cause of the dehiscence was unknown.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
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Search Alerts/Recalls
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