Wouldn¿t cross-got stuck on wire-not sure wire used.Patient outcome: the rep has been asked to provide the answers to the following questions.15jun2021 did any unintended section of the device remain inside the patient¿s body? -no if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? -no did the patient require any additional procedures due to this occurrence? -no if yes, please describe.Did the product cause or contribute to the need for additional procedures? -no if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? -no has the complainant reported that the product caused or contributed to the adverse effects? -no please specify adverse effects and provide details.The rep has been asked to provide the answers to the following questions.15jun2021 are images (e.G.Angiography, us etc.) of the device and/or procedure available? n/a, yes, no no was the device flushed before the procedure, as per ifu? n/a, yes, no yes were there any issues with flushing of the device? n/a, yes, no no details of the access sheath used (name, fr size,length)? 6-45 terumo destination details of the wire guide used (name, diameter, hyrdophyllic)? not sure what approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other contra lateral ¿ please specify for other: ¿ if contralateral, was the bifurcation angle steep? n/a, yes, no not sure what was the target location for the stent? heading to sfa what artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other sfa please specify for other: was the wire guide removed from the patient prior to advancing the delivery system? n/a, yes, no not sure if removed, was the wire guide wiped prior to advancement of the delivery system? n/a, yes, no not sure did the stent delivery system cross the target location? n/a,yes,no no didn¿t make it was pre-dilation performed ahead of placement of the stent? n/a,yes,no not sure assume yes was the patient¿s anatomy difficult or altered? not sure previous bypass, tortuous, calcified, altered, other ¿ if other, please specify: was resistance encountered when advancing the wire guide? n/a, yes, no not sure was resistance encountered when advancing the delivery system to the target location? n/a, yes, no yes was resistance encountered when deploying the stent? n/a, yes, no didn¿t get to deploy it wouldn¿t cross how did the physician deal with any resistance encountered? took stent out was the stent fully deployed in the patient before removing the delivery system? n/a, yes, no no after deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other n/a ¿ if other, please specify: was post-dilation performed after the placement of the stent? n/a,yes,no not sure did any portion of the device break off? n/a, yes, no no ¿ if yes, please state what part: when did the device break? n/a, prep, advancement, deployment, withdrawal, after removal thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? n/a, yes, no not sure thumbwheel only ¿ was the retraction sheet being held during deployment.N/a, yes, no n/a did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? n/a, yes, no n/a ¿ if yes, was the stent partially deployed? n/a, yes, no n/a ¿ if yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a, removed, deployed n/a if removed, did any part of the stent fracture during removal of the delivery system? n/a, yes, no n/a was the delivery system kinked or twisted during advancement or deployment? n/a, yes, no n/a please advise if and when any damage was observed on the; wireguide n/a, yes, no not sure ¿ prior to use, during use, post procedure delivery system n/a, yes, no not sure ¿ prior to use, during use, post procedure not sure ¿ if yes, please specify (e.G.Kinked or twisted): not sure what intervention (if any) was required? n/a was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day used eluvia stent instead were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no no ¿ please specify if yes.
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