Corrected data: on block h6, medical device ¿ problem code , code 3190 is replaced by code 2993.(3331/213) the device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.(4111/3221) the investigation involved communication with the surgeon who reported the event.However, no further information could be obtained about the event.Additional manufacturer narrative: all the available information related to the 3 pseudoaneurysms cases reported jointly by the same physician have been sent to the medical affairs whose assessment is as follows: "getinge received a series of (3) product complaints, all similar in nature from a single user.Each complaint describes the uneventful implantation of an intergard vascular graft for a femoral-popliteal bypass procedure and subsequently developed a pseudoaneurysm requiring endovascular surgical intervention.The bypass procedures occurred in 2012, 2014 and 2015 and the pseudoaneurysm was discovered 6 years, 2 years and 7 years, respectively, after implantation.In the complaints, there was no mention of the complexity of the fem-pop procedure or of any post-operative complications including symptoms such as pain, swelling, or infection.In each case, the location of the pseudoaneurysm is unknown and there is no diagnostic imagining available for review.The complainant states that in each case, the graft remained implanted and the pseudoaneurysm was repaired successfully using one or two covered stents.On further questioning, specifically regarding the complexity of the procedure as well as the vessel quality and location of the pseudoaneurysm, there was reluctance from the surgeon to provide any additional information.These answers may have helped to narrow down the potential cause of the pseudoaneurysm.Review of the device history records for the devices concluded that there was no non-conformance in relation to the event reported.Clinical literature reports that arterial pseudoaneurysm due to breakdown of surgical arterial anastomosis is a known complication of arterial bypass with vascular graft procedures.(1) the most common location for pseudoaneurysm is the common femoral artery to bypass graft junction, which occurs in 0.8-2.2% of revascularization procedures.(2).In conclusion, there is a lack of vital information to fully understand the cause of these 3 complaints of pseudoaneurysm.It is reasonable to assume that the formation of the pseudoaneurysm was due to due the breakdown of the anastomosis.All 3 patients required endovascular surgical intervention to repair the pseudoaneurysm.The devices in these complaints could not be investigated further as they remain implanted.References: (1).Jon c.Henry, md, ms, rpvi, fica, randall w.Franz, md, facs, rvt, rpvi, rica; pseudoaneurysms of the peripheral arteries; int j angiol 2019;28:20-24 (2).D.Baldwin, h.Mashbari, k.L.Chow, and m.Sarhan; ruptured superficial femoral artery anastomotic pseudoaneurysm after 30 years ¿ case report; published 22 july 2019." (4315) no conclusion can be drawn on the exact origin of the defect since the product remained implanted and limited information was provided by the reporter.However, the conducted investigation suggests that the device was not defective.The cause of the event is likely related to a known complication of the procedure.(22) to be noted that pseudoaneurysm is an expected undesirable side-effect as indicated in the product instructions for use.
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