The additional mitraclip mentioned in b5 and d10, and the steerable guide catheter mentioned in b5 are filed under separate medwatch numbers.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.The investigation determined the reported tissue injury and recurrent mitral regurgitation (mr) appears to be related to the procedural condition of the partial clip movement of the other clip.The reported dyspnea, hypotension, heart failure, angina, and swelling/edema appear to be cascading effects of the recurrent mr.Mr, dyspnea, hypotension, heart failure, angina, swelling/edema are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization, medication required, and surgical intervention were results of case-specific circumstances as the patient remained hospitalized, medications were provided, and surgical intervention was performed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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This report is being filed due to tissue injury, heart failure, and recurrent mitral regurgitation requiring treatment.Crd_947 - repair mr ide study patient id: (b)(6).It was reported that on 01/10/2024, the patient presented with degenerative mitral regurgitation (mr) with an enlarged left atrium and posterior flail.Two mitraclips ((cds0706-xtw, 30522a1001 and 30523a1064 (medial)) were successfully delivered and deployed, reducing the mr to grade 1+.On 01/11/2024, residual, moderate to severe mr was noted.Reportedly, it was thought that the medial mitraclip (cds0706-xtw, 30523a1064) had slipped off the posterior leaflet.This was observed on a later date.There was no single leaflet device attachment (slda).On 01/13/2024, the patient presented to the emergency department with chest pain and atrial fibrillation.On 01/18/2024, the patient was seen by the cardiologist for progressive dyspnea on exertion, lower extremity edema, a new cough, orthopnea, paroxysmal nocturnal dyspnea, and severe mr was noted.On 01/19/2024, the patient presented with dyspnea, hypotension, mr, and worsening acute heart failure was diagnosed.The patient was admitted to cardiology for treatment.The patient was also covid positive.Medications had been provided.Per imaging, the medial mitraclip (cds0706-xtw, 30523a1064) had slipped off the posterior leaflet.There was no slda noted.On 01/14/2024, the patient presented to the emergency room with chest pain.Atrial fibrillation was noted, treated with medications.The event resolved.The physician deemed the atrial fibrillation unrelated to the mitraclip device.On 01/21/2024, a deep vein thrombosis (dvt) of the lower extremity was noted.On 01/26/2024, per imaging, acute infarcts were observed within the cranium and a cerebrovascular accident (cva-stroke) was diagnosed, likely cardioembolic.There was no acute intracranial hemorrhage.Per physician, the dvt and stroke were unrelated to the mitraclip device.On (b)(6) 2024, moderate to severe mr was noted and a mitral valve replacement was performed.Additional procedures performed included a left atrial maze (for atrial fibrillation) and closure of the left atrial appendage (laa) and atrial septal defect (asd) was performed.Reportedly, once the clips were removed, there was both anterior and posterior leaflet endothelial damage.The tissue injury was associated with both implanted mitraclips.Per physician, the atrial fibrillation treated with maze was unrelated to the mitraclip device.The asd was deemed related to the steerable guide catheter related and had been closed during the surgery.
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