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Model Number 45-481015-L |
Device Problems
Unraveled Material (1664); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/21/2022 |
Event Type
Injury
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Event Description
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It was reported that during embolization treatment of a left hepatic artery aneurysm, the coil was retracted and positioned without encountered resistance.The coil was report to have detached from the delivery pusher.Attempts were made to retract and advance the coil unsuccessfully.The majority of the coil remained within the microcatheter which was still positioned within the common hepatic artery and celiac trunk.The coil was snared within the 5fr base catheter via the micro catheter.The proximal portion of the coil was successfully snared, however only a small portion of the coil was retrieved on retraction.The main portion of the coil was deployed within the distal common hepatic artery and proximal common hepatic artery by injection of saline via the base catheter.As this was non-occlusive, the coil was left in situ.On removal of the base catheter it was reported that there remained a long attached, unraveled portion of coil extending back to the celiac axis, aorta and right common iliac artery.Patient is not showing symptoms from the mal-positioned coil at this time.No patient harm or injury was reported.No further treatment is planned to address the unraveled portion of the coil.
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Manufacturer Narrative
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A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has not yet been returned to the manufacturer; therefore, a product evaluation could not be performed and the alleged product issue could not be confirmed.If the device or additional information is received, microvention, inc., will issue a supplemental mdr report.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
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Manufacturer Narrative
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The pusher and introducer sheath were the only components received for evaluation.The investigation of the returned coil system found the implant to be separated from the pusher.No indication of using a detachment controller was found on the pusher's heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament, causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.Imaging was provided that did show a mass of coils in the hepatic aneurysm with a gradually stretched coil running from the aneurysm to the hepatic artery with a thin filament seen in the visible portion of the abdominal aorta.
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Search Alerts/Recalls
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