A visual inspection was performed on the returned device.The reported difficult to advance/position could not be tested due to the condition of the returned device; however, the stent implant was noted to be dislodged from the balloon and moved distally on the stent delivery system (sds).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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to advance/position.Factors which may contribute to difficulty advancing the device in the introducer sheath include, but are not limited to, damage to the stent, damage to the guiding catheter, introducer sheath 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 guide catheter / introducer sheath 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 and introducer sheaths 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.It is possible the observed stent dislodgement may have occurred during insertion or removal of the device inside the sheath; however, this cannot be confirmed, as the physician did not recognize the stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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