Reporting status: serious injury/medical intervention.
Reporting rationale: resistance with a graftmaster is an issue known to require a second device or additional procedure.
Device issue: resistance.
It was reported that during a lad stenting procedure, the physician implanted a xience v stent, intentionally jailing the 1st diagonal.
Post stenting, additional stenosis was noted at the proximal end of the 1st diagonal which the treated via pta using a 2.
5 x 15 rx voyager.
During inflation of the balloon, a dissection occurred within the 1st diagonal.
The physician attempted to insert the jostent graftmaster device into a 6f sheath (the ifu reads that a 7f sheath should be used).
The device would not insert and the physician discarded the device.
The device was never deployed/implanted.
The physician re-inserted the rx voyager and inflated the balloon at low atm and the dissection resolved successfully without further intervention.
There was no patient complications.
There is a additional information available.