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Model Number 100256HS-V-A2 |
Device Problems
Break (1069); Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains partially impanted in the patient; however, the delivery pusher with broken part of device is availalbe, but was not received at time of this report.At this time, the alleged product issue cannot be confirmed.If the device or additional information is received, mvi will submit a supplemental report.The instructions for use (ifu) identifies difficult coil detachment as potential complications associated with use of the device.
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Event Description
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It was reported that during a coil embolization procedure for the treatment of a ruptured anterior communicating (acom) artery aneurysm, 5 coils were used.The first 4 coils were implanted successfully and formed a stable package.The fifth coil stretched and broke into two parts during deployment; however, the broken distal part remained in the implanted coil package.The delivery pusher with rest of broken coil were successfully removed from the patient.No further coils were used.The event had no influence on patient's outcome.The aneurysm could be treated successfully and the patient is doing fine.
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Manufacturer Narrative
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Additional information: d9, h3, h6, h10 (summary device evaluation).Summary device evaluation: the investigation of the returned coil system found the pusher hypotube bent, the proximal gold connector bent, and the implant completely stretched but still attached to the pusher with no signs of activation using a detachment controller.The stretched implant condition is consistent with the coil becoming stuck or experiencing friction during repositioning within the aneurysm (i.E.Stuck on previously implanted coils or the tip of the microcatheter).Due to the presence of the implant's distal glue ball, this investigation determined that the implant did not break during the procedure as described in the reported event.Furthermore, the customer provided images did not show a loose piece of the implant inside the parent artery.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces over specification.
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Search Alerts/Recalls
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