Catalog Number UNK SGC01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908); Perforation (2001)
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Event Date 11/27/2016 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: date estimated.The udi number is not known as the part and lot number were not provided.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature: haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy.
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Event Description
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This is being filed to report the atrial septal defect (asd) requiring intervention for treatment and cardiac arrest.It was reported via literature that this was a mitraclip procedure to treat functional mitral regurgitation (mr).The mitraclip was successfully implanted.Following withdrawal of the steerable guide catheter (sgc), the systolic pulmonary pressure increased, right-sided chamber enlargement was observed and a left-to-right shunt was detected, eventually leading to cardiorespiratory arrest.The issue was resolved through percutaneous closure with either an amplatzer or figulla occluder.No additional information was provided.Details are listed in the article: "haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy".
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Manufacturer Narrative
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D4: the udi# is unknown because the part and lot numbers were not provided.The device was not returned for analysis and a review of the lot history record could not be performed as the lot information regarding the complaint devices was not provided.Based on the information reviewed, the reported perforation appears to be due to procedural condition.Hypertension and subsequent cardiac arrest is a cascading effect of the perforation.Perforation, hypertension, and cardiac arrest are listed in the mitraclip instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported unexpected medical intervention is a result of case-specific circumstance.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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