Catalog Number CDS0501 |
Device Problems
Failure To Adhere Or Bond (1031); Incomplete Coaptation (2507)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/02/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
|
|
Event Description
|
This is filed to report the single leaflet device attachment (slda).It was reported this was a mitraclip procedure performed to treat mixed mitral regurgitation (mr) with a grade of 4+.The transseptal puncture was difficult due to atrial dilatation; the puncture was low with an aorta hugger.Imaging was challenging due to the anatomy.Standard steering techniques were used to gain height to the mitral valve.The clip delivery system (cds) (70925u343) was advanced to the mitral valve, grasping was difficult due to the annular dilation and due to bi-leaflet prolapse.The leaflets were eventually grasped, and the clip was deployed.However, two minutes later, when removing "m" from the device to remove the delivery system; it was noted that the clip detached from the posterior leaflet and remained attached to the anterior leaflet (slda).The mr was 3+.Since it took approximately 2 hours and 20 minutes to grasp with the clip, the decision was made to discontinue the procedure.The patient remained hospitalized for a second mitraclip procedure, which was performed on (b)(6) 2018.During the second procedure, leaflet grasping was unsuccessful with the cds due to the anatomy.The cds was removed with the clip and the procedure was aborted.The mr remains 3+.The patient is stable.No additional information was provided.
|
|
Manufacturer Narrative
|
(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.All available information was investigated and the single leaflet device attachment (slda) and failure to adhere/bond (difficult grasping) and poor image resolution in this incident appears to be related to patient morphology/challenging anatomy (bi-leaflet prolapse with annular dilation, coaptation length 0mm, dilated right and left atrium with rotation of the heart).Based on the information reviewed, there is no indication of a product quality issue with respect to design, manufacturing, or labeling of the device.
|
|
Search Alerts/Recalls
|
|