It was reported that the procedure was performed to treat a lesion in the moderately calcified, moderately tortuous common iliac artery.A 9x29mm omnilink elite 35 stent delivery system (sds) was advanced, and the stent was implanted.However, the sds faced resistance with a non-abbott 6f sheath during removal.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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A visual and functional inspection was performed on the returned device.The reported difficult to remove was confirmed.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 difficulty to remove; however, factors which may contribute to difficulty removing the device from the introducer sheath include, but are not limited to, manufacturing, damage to the stent, damage to the guiding catheter, guiding catheter size selection or procedural technique (devices not properly supported or coaxially aligned).In this case, it may be possible that the inner diameter of the guide catheter was smaller than the recommended diameter of 0.085 inches (2.15 mm) indicated on the omnilink elite product label.It should be noted that there is no specific industry definition of 6f guide catheter dimensions or what it means to have a product that is 6f compatible.The only guidance the sheath producers have is to make the inner diameter larger than 2.00mm and smaller than 2.33mm.This contrasts with the convention for guiding catheters that have a clear definition of a maximum outer diameter of 2.0mm.The lack of clear industry guidance may be a contributing factor to why there is a broad range of inner diameters found in commercial introducer sheaths.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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