The US Food and Drug Administration (FDA) has recently issued its highest-level alert regarding a heart pump that has been associated with 49 deaths and 129 injuries. This medical device, known as the Impella left-sided pump, is also utilized in Hong Kong.
Impella left-sided pumps are designed to provide temporary support to a patient's heart during high-risk procedures or following a severe heart attack. However, the FDA has cautioned that incorrect usage of the device could potentially puncture the wall of the heart's left ventricle.
The pump consists of a catheter with a small hook at the end, which is threaded through the blood vessels and into the left ventricle. This chamber plays a crucial role in pumping oxygenated blood throughout the body. In response to the FDA's alert, the manufacturer of the device, Abiomed, has issued new instructions for its use.
Cardiologists in Hong Kong have stated that the device is primarily used for patients in critical or extreme conditions, and the brand associated with it holds the largest global market share. The FDA classified the recent recall as the "most serious type of recall" due to the potential risk of severe injuries or even death if the device is misused. The agency has further warned that the use of affected pumps could result in serious adverse health consequences such as hypertension, inadequate blood flow, and mortality.
The notification pertains to approximately 66,390 devices that were distributed in the US over a two-year period starting from October 10, 2021. The Impella pump received FDA approval in 2008. Johnson & Johnson, which acquired Abiomed in 2022, clarified that this notification does not indicate a complete removal of the device from the market, and Impella heart pumps continue to be available for patients.
It is worth noting that Abiomed initially disclosed the risk of heart perforation during pump insertion in a technical bulletin issued in October 2021. However, the company did not share this information with the FDA at that time, as stated by the agency.
In conclusion, the FDA's highest alert regarding the Impella heart pump serves as a critical warning to healthcare professionals and patients alike. Proper usage and adherence to the new instructions provided by the manufacturer are essential to mitigate the potential risks associated with this medical device.
FDA 對導致 49 人死亡的心臟幫浦發出最高警報
美國食品藥品監督管理局（FDA）最近對一種與49人死亡和129人受傷相關的心臟幫浦發出了最高級別的警報。這種醫療設備，名為Impella左側幫浦，在香港也有使用。
Impella左側幫浦用於在高風險手術或嚴重心臟病發作後暫時支持患者的心臟。然而，FDA警告說，如果使用不當，該設備可能會刺穿心臟左心室的壁。
該幫浦由一根帶有小勾的導管組成，通過血管插入到左心室中。這個腔室在心臟中起著將充滿氧氣的血液泵送到全身的關鍵作用。作為對FDA警報的回應，該設備的製造商Abiomed已經發布了新的使用指南。
香港的心臟病專家表示，這種設備主要用於危急患者，並且該品牌在全球市場佔有最大份額。FDA將最近的召回分類為“最嚴重的召回類型”，因為如果設備使用不當，可能會導致嚴重的傷害甚至死亡。該機構進一步警告說，使用受影響的幫浦還可能導致嚴重的不良健康後果，包括“高血壓、血流不足和死亡”。
此通知涉及在2021年10月10日起連續兩年內在美國分發的約66,390台設備。該幫浦於2008年獲得FDA批准。該設備的製造商Abiomed在2022年被強生公司收購，該公司表示，此通知並不意味著完全從市場上撤出該設備，Impella心臟幫浦仍然可供患者使用。
值得注意的是，Abiomed最初在2021年10月的技術公告中披露了在插入幫浦時心臟穿孔的風險。然而，據FDA稱，當時該公司並未將這一信息與FDA共享。
總之，FDA對Impella心臟幫浦發出的最高警報對醫療專業人員和患者來說都是一個重要的警告。遵守製造商提供的新指南，正確使用該設備，對於減少與該醫療設備相關的潛在風險至關重要。
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