Model Number 1012630-59 |
Device Problems
Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a moderately calcified posterior tibial artery.During advancement of the 7.0x59mm omnilink stent delivery system, the stent got caught in calcium.An attempt was made to advance and retract the stent delivery system; however, the stent dislodged during advancement.It was noted that resistance was also felt with the guide catheter or sheath, but is unknown with which one.A cutdown was performed to retrieve the dislodged stent.A new omnilink stent was used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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A visual inspection was performed on the returned stent.The reported stent dislodgement was confirmed.The reported difficult to advance could not be tested as the stent delivery system (sds) was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported difficulties and subsequent treatments including removal of foreign body appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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