The U.S. Food and Drug Administration (FDA) has sent a letter to health-care providers warning about the potential for clip lock malfunctions on MitraClip Delivery Systems manufactured by Abbott. Abbott issued an “Urgent Medical Device Correction” on Thursday to alert providers to the issue. In the correction, Abbott noted that it has seen an increase in clip locking malfunction complaints. The reports are of clips failing to “establish a final arm angle” and for “clip opening while locked,” the company said. The final arm angle failure happens when the clip opens while the device is being prepared before deployment. The “opening while locked” happens when the arm angle increases after the device has been deployed; it can be identified using fluoroscopy, the company said. Between February 2021 and January 2022, the pre-deployment arm-angle failure rate was 0.51%, and the post-deployment failure rate was 0.28%. Between February and July 2022, those rates increased to 0.80% (pre-deployment) and 0.50% (post-deployment). The pre-deployment failure did not have any consequences for the patient in 91.7% of cases, while the post-deployment failure had no consequences for the patient in 60.4% of cases. Pre-deployment failure resulted in intraprocedural recurrence of mitral regurgitation (MR) in 7.7% of cases, while post-deployment failure led to this intraprocedural MR recurrence in 36.8% of cases. In its correction notice, Abbott said that while current MitraClip inventory does not need to be returned, it is changing its manufacturing process to address the issue. The company also emphasized certain parts of the instruction for use to minimize the chances of a lock malfunction happening. The FDA noted in its warning letter that the malfunction’s potential risks to patients include ineffective treatment of MR and a possible need for additional interventions, which could contribute to increased procedural risks such as bleeding, complication from implanting additional clips and longer procedural times. “Based on the available data on clip lock malfunctions and the associated risks, the FDA believes that the probable benefits of the MitraClip device continue to outweigh the probable risks for the approved indications for use,” the agency’s letter says. “The FDA is issuing this letter to ensure you are aware of the manufacturer's recall notice and recommended actions.” The FDA recommends that providers review Abbott’s notice, be aware of the potential for clip lock malfunctions before or after deployment and carefully read the instructions for use and recommendations in Abbott’s notice. Providers can report adverse events with the MitraClip via the FDA’s voluntary MedWatch reporting program. Device manufacturers and user facilities must comply with applicable reporting regulations. Image Credit: carmenbobo – stock.adobe.com