A visual and dimensional inspection was performed on the returned device.The reported material deformation was confirmed.The reported difficult to advance/position and difficult to remove 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 difficult to advance/remove (introducer sheath); however, factors which may contribute to difficulty advancing and removing the device in the introducer sheath include, but are not limited to, damage to the stent, damage to the introducer sheath/guiding catheter, introducer sheath/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 introducer sheath 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 introducer sheath / 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.In addition, the investigation determined the reported material deformation (damaged stent) appears to be related to the operational context of the procedure, which likely occurred due to interaction with the introducer sheath during advancement/retraction, as it was reported there was resistance noted during advancement and the device became stuck inside the introducer sheath.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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