Catalog Number SGC01ST |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
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Event Date 01/28/2016 |
Event Type
Death
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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 steerable guide catheter was reportedly discarded.Investigation is not yet complete.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 being filed due to femoral access site bleeding, femoral vein repair and death.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Following clip delivery system (cds) advancement into the left atrium and after the straddling position, severe hypotension was noted, treated with medications and a blood transfusion.Per the physician, the hypotension, and treatment of, was due to access site bleeding and not related to the cds.The mitraclip was successfully implanted, reducing the mr to 2.Following removal of the steerable guide catheter (sgc (b)(4), surgical repair of the femoral vein was performed.On (b)(6) 2016 the patient expired due to multi-organ failure related to right leg compartment syndrome.There was no additional information provided.
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Manufacturer Narrative
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(b)(4).As the device was not returned for evaluation, a failure analysis of the complaint device could not be performed.The analysis of this complaint was an assessment of the manufacturing records and information provided to abbott vascular.The investigation was unable to determine a definitive cause for the reported patient effects of hemorrhage and death in relation to the mitraclip procedure; however, the reported hypotension, treatment with medication, and surgical procedure were related to procedural circumstances.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).It should be noted that the reported patient effects of hemorrhage requiring transfusion, hypotension, and death, as listed in the mitraclip system instructions for use (ifu), are known possible complications associated with mitraclip procedures.Based on the reported information, the reported patient effect of hypotension appears to be related to the hemorrhage at the access site.Although a conclusive cause for the reported patient effects of hemorrhage and death and the relationship to the device, 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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Event Description
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Subsequent to the initial medwatch report filed, the additional information was obtained: according to the treating physician, the steerable guide catheter did not cause or contribute to the access site bleeding and need for femoral vein repair.
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Search Alerts/Recalls
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