Catalog Number SGC0302 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Atrial Perforation (2511)
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Event Date 11/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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This report is filed due to an atrial septal defect and arteriovenous fistula.It was reported that the patient presented with degenerative mitral regurgitation (mr) grade 3+, with a bi-leaflet prolapse (a3p3) and anterior leaflet flail.Two mitraclips were implanted without a device issue, reducing the mr to grade 1+.An atrial septal defect (asd) was treated with an asd closure device.Post-procedure, a groin arteriovenous fistula was noted.Imaging was performed and conservative treatment was provided with compressions.Prolonged hospitalization was required.The event resolved and the patient was discharged from the hospital on (b)(6) 2018.No additional information was provided regarding this issue.
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Event Description
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Subsequent to the previous medwatch report, the additional information was received: on (b)(6) 2018, a mitraclip procedure was attempted but was stopped since a left atrial thrombus was suspected.There was no mitraclip device in the anatomy during this time.Imaging was performed to rule out ischemia or vascular occlusion.No evidence was found.On (b)(6) 2018, a mitraclip procedure was performed, placing two clips without a device issue.An atrial septal defect (asd) was treated with an asd closure device.
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Manufacturer Narrative
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Internal file number - (b)(4).Device status changed from yes, returning to no, not returned.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.In this case, there was no reported device malfunction associated with the steerable guide catheter (sgc).The reported patient effect fistula (arterio-venous fistula), atrial perforation (cardiac perforation) as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.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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