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The model number provided is only the root of the actual model.The full model number was not provided.The product was not returned therefore no physical evaluation of the device could be completed.A review of the procedure video provided confirmed that the gold tick marker on the contralateral limb appears to have rotated when the limb was unsheathed.The lot number was not supplied, and therefore a review of the device history record could not be performed.There are processes during manufacturing that ensure that the graft and contralateral leg are correctly loaded onto the delivery system."slide a corresponding size peelaway, flared end first, over the tip of the delivery system.Symmetrically compress each stent on the graft with the snugger and ensure the distal attachment wire is held straight against the cannula while sliding the peelaway over each stent until the entire graft is compressed and the buffed tip of the peelaway is resting on the non-tapered part of the delivery system¿s tip.Extra care is to be taken with the gold marker stent on the short leg to ensure there is no twisting of the graft over the gold markers." "during compression of the external stent with the gold tick marker, ensure that the tick marker remains in the correct orientation forming a positive tick and does not fold over." "do not twist the sheath after transferring.Pull the peelaway backwards out of the captor valve." the instructions for use mentions: "to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula)." "advance delivery system until the contralateral limb is positioned in suitable orientation above and anterior to the origin of the contralateral iliac.If the contralateral limb radiopaque marker is not properly aligned, rotate the entire system until it is." "repeat angiogram to verify: the degree of overlap with proximal body (no less than 2 stents); the position of the contralateral limb; the position of the ipsilateral iliac limb with respect to the common iliac bifurcation.Reposition distal bifurcated body as required." additional information was requested and received.The additional information stated that: - the patient's anatomy was not tortuous.- there was no stenosis or narrowing at the aortic bifurcation/location of the gate.- the orientation of the contralateral limb confirmed prior to insertion (as per ifu).- there was no evidence of a twisted/rotated graft prior to insertion.- in response for clarification of how the graft rotated that it "seems like only leg appears to begin rotating just prior to unsheathing the proximal portion of contra leg stent, then rotation increases in speed and magnitude as distal edge is unsheathed." - in response to the question of 'does physician think that the graft was twisted within the sheath? or did the graft twist upon deployment?' that it was "difficult to visualize if twisted in the sheath, most definitely ¿twisted¿ during deployment" - it was "impossible to correct once proximal graft is wall opposed to zfen-prox" - the rotation of the graft caused difficulty cannulating or deploying distal components an additional eight complaints were received of 'gate rotation'; these are ((b)(4) - 9680654-2016-00012), ((b)(4) - 9680654-2016-00007), ((b)(4) - 9680654-2016-00013), ((b)(4) - 9680654-2016-00009), ((b)(4) - 9680654-2016-00008), ((b)(4) - 9680654-2016-00011), ((b)(4) - 9680654-2016-00014), and ((b)(4) - 9680654-2016-00017).These complaints were reported between september and november, 2016.There have not been any previous complaints reported for rotation of the contralateral limb and therefore, an investigation was performed on the complaints collectively to identify any trends and to assist in identifying potential root causes.The investigation included a review of the following: the number of physicians involved; a video of imaging of one of the complaint events; the clinical specialists involved; and the production operators that loaded the graft onto the delivery system.It was concluded that a review of the information present could not identify any common factors between all cases.There were five different physicians in total, two clinical specialists in total, three different operators that loaded the grafts (for the three lot numbers provided).Although a definitive root cause could not be established, it is possible that one or a combination of the following factors contributed to the complaints: - incorrect loading technique: the folding in of the contralateral leg could result in the appearance of twisting when released.- incorrect loading technique: twisting of the contralateral leg.- a significant overlap of the distal and proximal grafts may limit the space available for the contralateral limb to expand when unsheathed.- the significant overlap of both grafts could cause interference between or stent entanglement of the internal distal stent of the zfen-p graft and the external stent of the zfen-d graft.No further investigation is required as there is no evidence of a systemic issue, an investigation of the complaints collectively could not identify any trends, or a definitive root cause.The manufacturing instructions ensure that the graft, and contralateral leg, are correctly loaded onto the delivery system and the ifu supplied with the device provides deployment instructions to ensure correct deployment of the distal bifurcated graft, and also provides cautions to avoid any twist in the endovascular graft.
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