Heart valve repair device: USFDA warns of potential clip lock issue with Abbott Labs MitraClip
Abbott said it had received increased rate of reports of the devices failing to "establish final arm angle" or "clip opening while locked".
New Delhi: The U.S. Food and Drug Administration (USFDA) has alerted healthcare providers about a potential clip lock issue with Abbott Laboratories' MitraClip device used to stop heart valve leakage.
The medical device treats mitral regurgitation, a condition in which the mitral valve of the heart does not close properly, causing blood leakage that can lead to stroke, heart attack or even death. MitraClip was first approved in 2013.
The FDA said the malfunctions appear to occur in about 1.3% of MitraClip procedures and have been observed with all device models.
Abbott said it had received increased rate of reports of the devices failing to "establish final arm angle" or "clip opening while locked".
Read also: Abbott restarts Similac infant formula production at Michigan facility
The company said it has identified the cause of the clip lock malfunction and was working on producing new lots of the device with updated manufacturing processes and raw materials to mitigate the issue.
The health regulator said majority of the reported malfunctions have not been associated with "adverse patient outcomes" and based on the available data it believes benefits continue to outweigh the risks for use of the device.
Read also: Abbott gets USFDA nod for new Proclaim Plus spinal cord stimulation device
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.