Catalog Number 11012-19 |
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 08/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional omnilink elite stent delivery system referenced is filed under a separate medwatch report number.Na.
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Event Description
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It was reported that the procedure was to treat the subclavian artery with 95% stenosis.A 6fr sheath was used to deliver a 9.0x19 mm omnilink elite stent delivery system (sds); however, the stent dislodged and had to be retrieved via snare.Resistance was noted with the 6fr sheath prior to the dislodgement.Another 9.0x29 mm omnilink elite sds was attempted but it failed to cross the lesion and the stent was loose on the balloon.Resistance was noted with the 6fr sheath prior to the stent becoming loose on the balloon.To prevent another stent dislodgement, the stent was embedded into the vessel wall and the procedure was completed.No additional information was provided.
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Event Description
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It was reported that the procedure was to treat the subclavian artery with 95% stenosis.A 6fr sheath was used to deliver a 9.0x19 mm omnilink elite stent delivery system (sds); however, the stent dislodged and had to be retrieved via snare.Resistance was noted with the 6fr sheath prior to the dislodgement.Another 9.0x29 mm omnilink elite sds was attempted but it failed to cross the lesion and the stent was loose on the balloon.Resistance was noted with the 6fr sheath prior to the stent becoming loose on the balloon.To prevent another stent dislodgement, the stent was embedded into the vessel wall and the procedure was completed.Subsequent to the initially filed report the following information was provided: after the first stent dislodged an attempt was made to retain the guide wire and remove the sds but the length of the sds and guide wire didn't match so the sds could not be completely removed and the physician cut the shaft of the device.No additional information was provided.
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Manufacturer Narrative
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A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to advance could not be tested due to the condition of the returned device.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 was unable to determine a conclusive cause for the reported difficulties; however, the subsequent treatment appears to be related to the operational context 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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