Catalog Number CDS0706-XTW |
Device Problems
Break (1069); Difficult to Remove (1528); Difficult to Open or Close (2921)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 04/02/2024 |
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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It was reported that on (b)(6) 2024, a mitraclip procedure was performed to treat mixed mitral regurgitation (mr) grade 4.A xtw (lot: 31026a2062) was chosen for implantation.The clip was advanced to the valve.During initial grasping attempts, the clip became stuck in the chordae.The clip was able to be freed via troubleshooting but chordal damage had occurred.The patient's pre-exisitng flail increased.Once free the clip grasped the leaflets again, but one of the grippers was not functioning when attempting to raise.The clip was removed from the patient where the gripper line was observed to be broken.No replacement device was used and the procedure was aborted with mr unchanged grade 4.
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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 did not indicate a lot-specific quality issue.The investigation determined the reported difficult to remove of clip being stuck in the chordae appears to be due to user grasping technique.The reported gripper line break and subsequent gripper actuation issue appear to be due to the clip being stuck in the chordae.The reported tissue injury (chordal damage) appears to be related to the clip being stuck on the chordae.Tissue injury is listed in the instructions for use as a known possible complication associated with mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as no treatment was provided for the tissue injury.There is no indication of a product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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