A medical device manufacturer has stopped the production and use of a heart pump device following the death of a patient.
Abbott Laboratories, an American-based worldwide healthcare company, has halted the use of the HeartMate PHP catheter following a patient death and several malfunctions in the U.S. and in Europe.
The device was initially thought to be commercially promising, but the problems identified are serious.
About the heart pump
The medical device was praised by both medical manufacturers, St. Jude and Abbott Laboratories, as a device that was in advanced clinical testing.
The blood pump consists of a propeller inside a thin wire cage that is inserted in the heart to keep blood flowing at a predictable rate for up to 6 hours when patients are undergoing high-risk surgery to unblock clogged blood vessels. The advantage of such a device is to allow doctors/surgeons to place the device in the heart without needing to perform open-heart surgery.
Recall
Issue were first addressed by regulators in Germany. On 6th February 2017, a recall note was issued asking for use of all devices to be halted, and for devices to be returned.
Abbott Laboratories said it received 8 reports of the medical pumps stopping during high-risk surgical procedures, and notes that in one case, the problem caused an irregular blood flow which necessitated emergency intervention to save a patient’s life.
Another case reported that a patient died as a result of “sepsis several days after the intervention”.
Numbers affected
Abbott Laboratories noted that 8 problems affected some 1.9% of the devices shipped from the factory. This implies that approximately 420 devices are potentially affected by the recall notice.
The recall noted:
“Abbott is temporarily pausing the use of HeartMate PHP devices to allow the company time to evaluate and implement corrective actions… In the interim, do not use units within your possession… Hospitals will be required to return all HeartMate PHP catheter inventory to Abbott.”
A commercially viable device?
The medical manufacturer has also suspended a patient study (Shield II) which involved 425 individuals testing the HeartMate PHP and a similar heart pump device manufactured by Abiomed. Abbott Laboratories confirmed that the suspension of the trial was due to uncertainty of the safety of such devices. Abbott Laboratories’ spokesperson, Justin Paquette, said: “…the pause in our U.S. study and commercial implants [in Europe]… are being taken as a precaution due to reports of a low number of clinical events associated with pump stoppage”.