Catalog Number SGC0301 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Embolism (1829); Neurological Deficit/Dysfunction (1982); Thrombosis (2100)
|
Event Date 06/06/2018 |
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 relevant information.
|
|
Event Description
|
This is filed to report the thrombus and embolism.It was reported that this was a mitraclip procedure to treat a degenerative mitral regurgitation (mr) with a grade of 4.During insertion of the steerable guide catheter (sgc), while the sgc was in the right atrium and the dilator tip was just across the septum, thrombus was noted in the left atrium.There were no clinical symptoms due to the thrombus, but after several hours the patient developed slurred speech.There had been no evidence of clot/thrombus on the guide wire prior to dilator insertion.A multipurpose catheter was used to aspirate the thrombus and it was captured inside the syringe.Three clips (71205u190, 80314u119, 80103u147) were implanted reducing mr to 1.Several hours later after successful extubation, a neurological exam was performed and it was noted that the patient had developed a clot in his brain.The patient was transferred to another facility for treatment, but there was no intervention required.The patient was ambulatory and doing well.No additional information was provided.
|
|
Manufacturer Narrative
|
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effect of embolism appears to be related to procedural conditions; however, a cause for the clot (thrombus) could not be determined.In addition, the reported neurological deficit/dysfunction appears to be a result of the embolism.The reported patient effect of emboli and thrombus, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Search Alerts/Recalls
|
|