Catalog Number UNK SGC03 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Atrial Perforation (2511)
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Event Date 07/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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(udi#): in the absence of a reported part number, the udi number cannot be calculated.The device remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Article: iatrogenic atrial septal defect following the mitraclip procedure: a state-of-the-art review.
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Event Description
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This is filed to report after the mitraclip procedure, the atrial perforation had to be closed with an occulder.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with grade 4.Two clips were implanted, uncomplicated procedure.15 days later, follow-up transthoracic echocardiography (tte) showed persistent atrial septal defect (asd), mild left to right shuntdetails are listed in the article, iatrogenic atrial septal defect following the mitraclip procedure: a state-of-the-art review.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record could not be performed as lot and part number was not provided.A definitive cause for the reported patient effect of atrial perforation could not be determined in this case, however atrial perforation is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.Hospitalization and additional therapy/ non-surgical treatment was a result of case-specific circumstances as the patient was treated using an amplatzer asd occluder.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.D1.Removed unknown mitraclip and changed to mitraclip® system steerable guide catheter/ d2.Removed nkm and added dra.D4.Changed from unk cds to unk sgc.
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Search Alerts/Recalls
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