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Catalog Number SR08100XL |
Device Problem
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 04/04/2024 |
Event Type
malfunction
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Event Description
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As reported, after implantation of an 8mm x 100mm smart radianz self-expanding stent (ses), when removing the delivery system from the patient over a 300cm vassallo floppy guidewire, it was noticed that the front end was torn off.The 10cm separated segment remained on the vassallo guidewire and was able to be removed without issue by pulling the guidewire.Additionally, there was some resistance when removing the delivery system due to resistance with the guidewire.The procedure continued by implanting a 7mm x 60mm smart vascular ses at the external iliac artery (eia).The right common iliac artery was then treated, and the procedure was completed.There were no reported injuries to the patient.This was during a procedure to treat two separate lesions, one in the left common iliac artery to external iliac artery (eia), and one in the right common iliac artery to superficial femoral artery (sfa).The eia lesion had a stenosis of 85% - 95% and was moderately calcified.The sfa lesion had a stenosis of 90%-100% and was moderately calcified.A 6f 90cm non-cordis guiding sheath was used for access from the left brachial artery to the left iliac artery.Various unknown guidewires were used and were able to pass.An unknown balloon catheter was used for pre-dilation.The smart radianz ses delivery system was stored and prepped per the instructions for use (ifu).The device will be returned for evaluation.
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Manufacturer Narrative
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This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
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Manufacturer Narrative
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After further review of additional information received the following sections have been updated accordingly.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
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Event Description
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As reported, after implantation of an 8mm x 100mm smart radianz self-expanding stent (ses), when removing the delivery system from the patient over a 300cm vassallo floppy guidewire, it was noticed that the front end was torn off.The 10cm separated segment remained on the vassallo guidewire and was able to be removed without issue by pulling the guidewire.Additionally, there was some resistance when removing the delivery system due to resistance with the guidewire.The procedure continued by implanting a 7mm x 60mm smart vascular ses at the external iliac artery (eia).The right common iliac artery was then treated, and the procedure was completed.There were no reported injuries to the patient.This was during a procedure to treat two separate lesions, one in the left common iliac artery to external iliac artery (eia), and one in the right common iliac artery to superficial femoral artery (sfa).The eia lesion had a stenosis of 85% - 95% and was moderately calcified.The sfa lesion had a stenosis of 90%-100% and was moderately calcified.A 6f 90cm non-cordis guiding sheath was used for access from the left brachial artery to the left iliac artery.Various unknown guidewires were used and were able to pass.An unknown balloon catheter was used for pre-dilation.The smart radianz ses delivery system was stored and prepped per the instructions for use (ifu) and there were no difficulties flushing the device.The device will be returned for evaluation.
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Search Alerts/Recalls
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