Catalog Number CDS0702-NTW |
Device Problem
Positioning Failure (1158)
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Patient Problems
Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
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Event Date 03/06/2024 |
Event Type
Death
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Manufacturer Narrative
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The device will not be returned for evaluation as the device was reportedly discarded.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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It was reported this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4, rotated heart and thin leaflets.One clip was successfully implanted.To further reduce mr, an additional clip was inserted, but after several grasping attempts, a perforation was observed on the anterior leaflet.Therefore, the physician decided to removed the clip and discontinue the procedure.Mr remained at a grade of 4.There was no clinically significant delay in the procedure.On (b)(6) 2024, the patient underwent mitral valve replacement (mvr).On (b)(6) 2024, the patient passed away.It was noted that the patient was not suitable for surgery.The physician stated the clip contributed indirectly to the death as the tissue damage resulted in mvr.
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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.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported unable to grasp leaflets and difficult imaging were due to patient anatomy.The cause of the reported perforation and death were unable to be determined.The reported unchanged mr was a cascading event of the reported perforation.The reported patient effects of tissue injury, mitral regurgitation, and death, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result 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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