Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 3008264254-2020-00002 and 3008264254-2020-00003 are related to the same incident.
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This complaint is from a literature source.As reported in the literature publication entitled ¿optimal guiding catheter length for endovascular coiling of intracranial aneurysms in anterior circulation in era of flourishing distal access system¿.9 patients with anterior circulation aneurysms who underwent aneurysms embolization with guiding catheter envoy experienced arterial spasm due to the guiding catheter tip displacement during the procedure, as a result, the catheters were withdrawal.Purpose: to determine the minimum required guiding catheter length for embolization of various intracranial aneurysms in anterior circulation and to analyze the effect of various patient factors on the required catheter length and potential interaction with its stability.Materials and methods: from december 2016 to march 2017, 90 patients with 93 anterior circulation aneurysms were enrolled.Three types of guiding catheters (envoy, envoy da, and envoy da xb; codman neurovascular, raynham, ma, usa) were used.We measured the in-the-body length of the catheter and checked the catheter tip location in the carotid artery.We analyzed factors affecting the in-the-body length and stability of the guiding catheter system.
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