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Already had a stent on the other side that was placed by a different physician at a different lab (medtronic abre stent).Patient outcome: the following information has been received via email on 19jun2023.Sg 19jun2023.1.Did any unintended section of the device remain inside the patient¿s body? no.2.Was the patient hospitalized or was there prolonged hospitalization? no.3.Did the patient require any additional procedures due to this occurrence? an additional stent was used inside the elongated stent.4.Did the product cause or contribute to the need for additional procedures? no.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no.6.Has the complainant reported that the product caused or contributed to the adverse effects? no.Patient/event info - notes: the following information has been requested via email on 15jun2023 / 19jun2023.Sg 19jun2023.3.91 are images of the device or procedure available? n/a, yes, no.3.92 did the patient have pre-existing conditions? n/a, yes, no.If yes, please specify: 3.93 please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.¿ if other, please specify: 3.94 was a stent previously placed during previous procedures? n/a, yes, no.3.95 was the device used percutaneously? n/a, yes, no.3.96 where on the patient was the percutaneous access site? 3.97 was the access site jugular or femoral? n/a, jugular, femoral other.If other, please specify: 3.98 what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? if other, please specify.3.99 was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral.3.100 was pre-dilation performed ahead of placement of the stent? n/a, yes, no.3.101 what was the target location for the stent? 3.102 details of access sheath used (name, fr size, length)? 3.103 was the device flushed through both flushing ports before the procedure, as per ifu? n/a, yes, no.3.104 details of the wire guide used (name, diameter, hyrdophyllic)? 3.105 was resistance encountered when advancing the wire guide to the target location? n/a, yes, no.3.106 was resistance encountered when advancing the delivery system to the target location? n/a, yes, no.3.107 if resistance was met, how did the physician address this? 3.108 did the tip of the delivery system cross the target location? n/a, yes, no.3.109 did the user pull the handle towards the hub during deployment, per ifu? n/a, yes, no.3.110 did the user push the hub during deployment? n/a, yes, no.3.111 did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no.3.112 was the stent deployed smoothly / without resistance? n/a, yes, no.3.113 was the stent fully deployed in the patient? n/a, yes, no.3.114 was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no.3.115 was post dilation performed after the placement of the stent? n/a, yes, no.3.116 was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no.3.117 what intervention (if any) was required? 3.118 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 3.119 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no.Please specify if yes.Please provide the originator a list of any additional manufacturer questions required for investigation.Sg 15jun2023.The following information has been received via email on 19jun2023.Sg 19jun2023.10.How was the procedure able to be completed? another stent was used to realign the elongated stent.11.Are images of the device or procedure available? yes but tough to see anything.12.Did the patient have pre-existing conditions? yes ¿ previous venous and arterial work done on her legs.Multiple venograms and angiograms done.Prior stents placed in other sides/areas of the body.13.Please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) chronic clot.14.Was a stent previously placed during previous procedures? not on the side we were working.15.Was the device used percutaneously? yes.16.Where on the patient was the percutaneous access site? popliteal vein.17.Was the access site jugular or femoral? n/a popliteal vein.18.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? chronic clot.19.Was the lesion approached via contralateral or ipsilateral? ipsilateral.20.Was pre-dilation performed ahead of placement of the stent? yes.21.What was the target location for the stent? common iliac vein.22.Details of access sheath used (name, fr size, length)? 8fr terumo pinnacle 10cm.23.Was the device flushed through both flushing ports before the procedure, as per ifu? yes.24.Details of the wire guide used (name, diameter, hyrdophyllic)? amplatz wire.035 260cm.25.Was resistance encountered when advancing the wire guide to the target location? no.26.Was resistance encountered when advancing the delivery system to the target location? no.27.Did the tip of the delivery system cross the target location? yes.28.Did the user pull the handle towards the hub during deployment, per ifu? yes.29.Did the user push the hub during deployment? no.30.Did the user remove slack in the delivery system before deployment, per ifu? yes.31.Was the stent deployed smoothly / without resistance? yes.32.Was the stent fully deployed in the patient? yes.33.Was the stent fully deployed before removing the delivery system from the patient? yes.34.Was post dilation performed after the placement of the stent? yes.35.Was the delivery system damaged/kinked/twisted during deployment? no.36.What intervention (if any) was required? an additional stent was used to realign the elongated stent.37.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same time.38.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? no.Per rep: i personally believe this was user error.The physician was quick to deploy the stent and initially deployed higher than we wanted.The stent had good wall opposition.I was watching the cranial marker not realizing the physician was pulling on the deployment system to try and bring the stent down ultimately stretching it out.He also deployed it very quick, and we were placing the distal end inside of a 12mm stent (we were deploying a 16mm stent).Ultimately, this was probably 50 50 on the stent and the physician.
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Pma/510(k) # p200023.Evice evaluation.This complaint is related to (b)(4) / mdr ref#3001845648-2023-00549 and (b)(4) / mdr#3001845648-2023-00643 and was raised to capture stent elongation on deployment.The zvt7-35-120-16-140 device of lot number c1855548 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.The device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records.Prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data.The review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/or label.It should be noted that the instructions for use (ifu0091) states the following: ¿repositioning of the device once deployment has begun (ie, the stent markers begin to flower) is not possible because the outer sheath cannot be re-advanced over the stent¿.¿stent deployment must be performed under fluoroscopic control¿.¿pull back on the stent delivery system under fluoroscopy until the radiopaque markers on the stent are at the desired position¿.¿allow several seconds for the stent to stabilize and to verify the intended deployment location¿.There is evidence to suggest that the customer did not follow the instructions for use image review.An image was not returned for evaluation.Root cause analysis.A definitive root cause of the use error was determined.From the information available, the physician was quick to deploy the stent and the stent deployed in a higher location that intended and the initial reporter said that the stent had good wall opposition.The user then pulled down on the delivery system in an attempt to try and bring the stent down to the intended location which resulted in the stent stretching.As previously mentions, the ifu contains steps which give instructions on verifying that the stent is at the intended deployment area before deploying and that repositioning the stent once deployment has begun is not possible.The user has not complied with the requirements of the ifu.User/use related complaints are considered foreseen misuse.It is unknown how the device will perform outside of instructions for use.Confirmation of complaint.Complaint is confirmed based on customer and/or rep testimony.Summary of investigation.According to the additional information received, when they went to deploy the stent it elongated, put another stent inside the other stent to complete the procedure.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the patient did not experience any adverse effects as a result of this occurrence.An additional stent was used to complete the procedure.The primary intended use of this additional stent was queried as if it was solely used for the purpose of aligning the elongated stent, it would be considered off label.The user confirmed that the primary purpose was to improve luminal diameter in the iliofemoral veins to treat residual symptomatic iliofemoral venous outflow obstruction.However, by doing this, the second stent also fixated to the elongated stent.Therefore, it is considered on label use.Investigation findings conclude a definitive root cause of use error was established.The user has not complied with the requirements of the ifu.Complaints of this nature will continue to be monitored for potential emerging trends.
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