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U.S. Department of Health and Human Services

Medsun Reports

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Type of Device:
Temporary Non-Roller Type Left Heart Support Blood Pump
Device Brand Name:
Device Manufacturer's Name:
Abiomed, Inc.
Date of this Report:
Describe the Event
or Problem:
In the evening, the patient finished a bowel prep and was scheduled for a computed tomography (CT) colonoscopy. Upon transfer from the patient's bed to the CT scan table the patient’s Impella device stopped working. Alarm messages of placement signal not reliable, Impella stopped, retrograde flow, motor current high displayed on console. A backup Impella console was immediately retrieved and changed however there was no motor function on the backup. The Abiomed representative was contacted to monitor the Impella remotely. The Impella representative recommended that urgent replacement of the Impella motor be initiated. The patient was noted to still be conscious, but her blood pressure was compromised. The teams were at the bedside immediately. The Impella insertion site was Subclavian via graft. The Cardio Thoracic Surgery team was consulted and bedside Extracorporeal Membrane Oxygenation (ECMO) cannulation was arranged. Epinephrine and Levophed drips were started immediately however the patient's hemodynamics deteriorated rapidly without Impella support. A code blue was called due to the loss of a pulse, VF/VT arrest with subsequent pulseless electrical activity (PEA) arrest. The patient was cannulated onto ECMO however the ECMO circuit was unable to flow above 2LPM and efforts were unsuccessful. A transesophageal echocardiogram (TEE) conducted demonstrated an akinetic heart. The decision was made to stop resuscitation after poor perfusion with no electrical or mechanical heart activity. In examining the pump catheter, there was notable thrombic material around the discharge ports of the pump, but it is unknown if this was present at the time of explant or formed later while sitting in a bag for over a day. The catheter will be given to the manufacturer for their evaluation. All pieces were removed, and an x-ray was taken. Results were negative.
the device(s) may have
caused or contributed to:
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