Catalog Number CDS0701-XTW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Swelling/ Edema (4577)
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Event Date 04/26/2023 |
Event Type
Injury
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Event Description
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This report is being filed due to worsening congestive heart failure and recurrent mitral regurgitation requiring treatment.(b)(6).Patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) with leaflet tethering, and an anterior leaflet prolapse with flail.One mitraclip was implanted, reducing the mr to grade 1+.On (b)(6) 2023, the patient was hospitalized with dyspnea, lower extremity edema, and acute congestive heart failure was diagnosed.Follow-up was performed with cardiothoracic surgery and progressive, severe mr with an eccentrically directed jet was noted.Medications had been provided as treatment.Reportedly, the patient required multiple rounds of diuresis (medications provided).On (b)(6) 2023, the patient was hospitalized with recurrent mr.During this hospitalization, on (b)(6) 2023, a mitral valve replacement was performed.
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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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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, a cause of the reported recurrent mr could not be determined.The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported hospitalization and surgical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Event Description
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Crd_1002 - expand g4 phase 1 and phase 2 study.Patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) with leaflet tethering, and an anterior leaflet prolapse with flail.One mitraclip (cds0701-xtw, 10824r180) was implanted, reducing the mr to grade 1+.On (b)(6) 2023, the patient was hospitalized with dyspnea, lower extremity edema, and acute congestive heart failure was diagnosed.Follow-up was performed with cardiothoracic surgery and progressive, severe mr with an eccentrically directed jet was noted.Medications had been provided as treatment.Reportedly, the patient required multiple rounds of diuresis (medications provided).On (b)(6) 2023, the patient was hospitalized with recurrent mr.During this hospitalization, on (b)(6) 2023, a mitral valve replacement was performed.Subsequent to the previous reports, the additional information was received: the mitraclip had remained stable and well seated.There was no device related tissue injury observed.Per physician, the recurrent mr was device related.Per physician, the worsening heart failure was unrelated to the device.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the reported dyspnea, lower extremity edema, and acute congestive heart failure appear to be due to recurrent mitral regurgitation (mr).A cause of the reported recurrent mr could not be determined.The reported patient effects of heart failure, dyspnea, edema, and mitral regurgitation, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported hospitalization, surgical intervention, and medication required were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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