This section describes safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
5.1 Flow-limiting dissection was reported in 1 patient in a case series of 20 patients with erectile dysfunction and isolated penile artery stenosis treated by balloon angioplasty of the penile artery. It occurred after dilating the stenotic common penile artery lesion with a balloon catheter. After prolonged dilatation with the same balloon catheter, adequate distal run-off was established.
5.2 In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers did not list any anecdotal adverse events. They considered that the following were theoretical adverse events: puncture site complications, haemorrhage, pseudoaneurysm formation, vascular injury, distal embolisation leading to pelvic organ or buttock ischaemia, pelvic haematoma, contrast reaction, long-term complications related to angioplasty, stent migration, occlusion of stent.