It was reported that on (b)(6) 2021, the patient presented with monckeberg sclerosis in the aorta with runoff in peripheral vessels and heavy calcification.That day, a percutaneous intervention was performed on the right popliteal and right superficial femoral artery (sfa) containing this heavy/jagged calcification.Using a 6 french sheath, an ht command guide wire advanced through the acute/steep iliac bifurcation without issues.Following, an armada 18 and an armada 35 balloon dilatation catheter had advanced without issues.Upon first inflation attempt, both balloons had ruptured below rated burst pressure due to the heavy, jagged calcification.The catheters were removed without issue and another device was used in replacement.The first supera stent was successfully implanted.Following, a second supera stent delivery advanced with difficulty/resistance noted with the command wire, once at the steep bifurcation.The supera had then become stuck on the wire and was unable to advance or be removed.Both were removed as a single unit (the wire and supera sds).Another device was used in replacement, completing the procedure, without further issues noted.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.
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Visual analysis was performed on the returned device.The reported material rupture 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 revealed no other incidents and/or complaints reported from this lot.The investigation determined that the reported material rupture was likely due to case related circumstances.It is likely that the material rupture occurred due to interaction with the heavy lesion calcification.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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