Catalog Number UNK SGC01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Hypoxia (1918); 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 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 attachment :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) and treatment.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 patient immediately developed bronchospasm and pulmonary hypertension and a bidirectional shunt was detected.The issue was resolved through percutaneous closure with either an amplatzer or figulla occluder.No additional information was provided.Details are listed in the attached 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 review could not be performed as the part and lot information regarding the complaint device was not provided.Based on the information reviewed, the atrial perforation appears to be related to procedural conditions.A cause for the reported hypoxia (bronchospasm) and hypertension could not be determined.Hypoxia, hypertension and perforation are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.The reported unexpected medical inervention was a result of case-specific circumstances.There is no indication of product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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