Summary: the device in question was not returned therefore a proper investigation could not be performed.The details state that the stent was loose when the doctor was pushing the stent over the wire almost to the valve of the sheath; the stent came loose and was off the balloon.Atrium medical 100% inspects every device to ensure the stent was properly crimped in manufacturing.The device history records indicate that the crimped stent diameters of the 59 samples measured were within the proper range.In addition all 59 samples are placed through a 6fr introducer sheath prior to deploying the stents.This is conducted as part of the lot qualification performance testing.The likelihood that a stent was not crimped or properly crimped is extremely low.Without the device in question the crimped stent diameter cannot be verified.A full review of the catheter lot history records for the devices in question was performed.The records indicate that this lot of catheters passed atriums final lot qualification testing.This inspection requires that the catheter lot must pass the following: ability of the stent and delivery system to be passed through the labeled introducer sheath.Ability to deploy the stent at nominal pressure (8atm).Ability to withdraw the deflated balloon catheter back through the labeled introducer sheath.Ability of the delivery system to withstand 5 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the lot of stent delivery systems in question.The instructions for use specify the following: "special care must be taken not to handle or in any way disrupt the placement of the icast covered stent on the balloon.This is most important during catheter removal from the packaging, placement over the wire guide and advancement through the bronchoscope or endotracheal tube." clinical evaluation: there are several possibilities that can cause stent dislodgement including but not limited to manipulation of the stent prior to use, overuse of the sheath causing failure of the hemostatic valve and a hemostatic valve that is too tight.If personnel at the table were unfamiliar with the device and attempted to hand crimp or manipulate the product in any way prior to use it could interrupt the integrity of the stent.If other devices were passed through the sheath prior to the stent it is possible that the valve lost integrity and failed for that reason.If the sheath was inserted without the use of the enclosed obturator the hemostatic valve was potentially too tight for a first pass with the stent.This event may be associated with a delay in treatment.
|