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Model Number TV-AB2680-J |
Device Problems
Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
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Patient Problems
Anaphylactic Shock (1703); Low Blood Pressure/ Hypotension (1914); Failure of Implant (1924); Myocardial Infarction (1969); Rash (2033)
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Event Date 05/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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A review of the device quality records showed that the device demonstrated compliance to established procedures and specifications at the time of manufacture.
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Event Description
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An ovation ix abdominal stent graft system was implanted to treat an abdominal aortic aneurysm.Upon polymer fill of the aortic body stent graft, the polymer syringe was observed to have emptied indicating a potential intravascular leak of polymer, and the patient experienced hypotension and anaphylactic shock, and the skin appeared red and flush.The patient was treated for a hypersensitive reaction per the ifu and was stabilized.It was also noted that the patient developed a hematoma from the proglide placed in the left groin.The aneurysm was successfully excluded at the conclusion of the implant procedure.Two days post-op, the patient experienced a myocardial infarction, and was stabilized and discharged (b)(6) 2018.A cardiac bypass is planned at a later date.As of the date of this report, there have been no additional patient sequelae reported and the patient will continue to be monitored.
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Manufacturer Narrative
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The root cause for the emptying of the polymer syringe and intravascular leak of polymer could not be definitively confirmed with the information available.An evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Requests were made on (b)(6) 2018 and denied.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.Based on similar reported events, the most likely cause of the emptying of the polymer syringe and intravascular leak of polymer was likely due to a compromise in the integrity of the aortic body stent graft fill channels and/or mating junction of the delivery system to the stent graft; however, this could not be definitively confirmed.The delivery system was not available for evaluation and the stent graft remains implanted.As of the date of this report, there have been no additional patient sequelae reported.A review of the device quality records showed that the device demonstrated compliance to established procedures and specifications at the time of manufacture.A field safety notice (fs-0009) was released on (b)(6) 2018 to communicate the risk of polymer leak events with the ovation device under circumstances in which the device is not used in accordance with the device instructions for use.
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Search Alerts/Recalls
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