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COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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| Model Number G38483 |
| Device Problems
Difficult to Remove (1528); Difficult to Advance (2920)
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| Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 07/28/2020 |
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Event Type
malfunction
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Manufacturer Narrative
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Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Reported by the dm on behalf of the customer via complaint.Fully deployed the stent.Tried to remove the delivery system and "the system got caught on the wire" and they weren't able to pull the system off the wire.The wire was a rosen.Additional information provided by the dm on 31jul2020: "just picked up the delivery system from the customer.We have a few more cases, but i¿ll try and get it mailed out today or monday at the latest.They are not able to make a cd of the case, so i had them print out a few images.I have one of the bifurcation and 4 images of the stented area both pre and post stent.Just some additional info i picked up while i was here.They pulled back so hard on the delivery system that the rosen wire somehow came unwrapped.They verified with fluoroscopy that no part of the wire went downstream and was left in the patient.Once they pulled the wire and delivery system out they cut parts of the delivery system off until they reach the wire tip.They did this for additional verification that no part of the wire was left behind in the patient.So i¿ll be sending back the delivery system, the cut off parts of the delivery system, and the rosen wire." the following has been answered by the dm on 29jul2020: did any unintended section of the device remain inside the patient¿s body? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? no.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.The following has been answered on (b)(6) 2020: what is the lot # of the device? lot#c1739937.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? the patient was not hospitalized.Is the patient confirmed covid-19 positive? or has the device made contact with anyone confirmed to be covid-19 positive? the patient has not been confirmed covid19 positive.The device did not make contact with anyone that has been confirmed covid19 positive.Where was the access site? the access site was left femoral artery what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.? there was nothing abnormal regarding the patient anatomy.What was the target location for the stent? right superficial femoral artery was the target location severely calcified or tortuous? a chronic total occlusion with some calcium.Was the device flushed prior to use? the device was flushed prior to use.Were there any difficulties deploying the stent? no difficulties deploying the stent.Was the stent fully deployed before removing the delivery system from the patient? the stent was fully deployed.What other devices were used in the procedure? a 5 x 140 cook advance balloon was used to pre dilate and a 6 x 100 sterling from boston scientific was used to post dilate.Philips volcano ivus was used throughout the procedure.Were any additional procedures necessary as a result of this event? no.Can any photos, images, or reports of the procedure or device be provided? yes we can provide some pre and post images.Was the stent eventually deployed? the stent was deployed successfully.Was pre-dilatation conducted before stent deployment? the lesion was pre dilated with a 5 x 140 advance balloon.Was the handle pulled toward the hub while the delivery system remained stationary during deployment? the handle was pulled toward the hub while deployment.Was the wire guide hydrophilic or non-hydrophilic? the wire was a non- hydrophilic 0.035 rosen.How long was the procedure 0from advancing delivery system to the moment when the user attempted to remove the device? the stent was deployed within 2 minutes of insertion.Was the wire guide new or was the wire guide used previously before advancing the zilver delivery system? the same rosen wire was used to deploy the previous (2) 6 x 140 zilver ptx stents.If used, was the wire guide wiped between uses? the lesion was a cto of the sfa.A total of (3) 6 x 140 zilver ptx stents were used to treat the entire sfa.With the exception of the third delivery system getting stuck on the wire after deployment the case went well and the patient received a great outcome.The following has been requested on 12aug2020: could the available imaging please be forwarded to us for review.? images were printed off and returned with product, included images were the area treated, both pre and post stent.Along with an image of the bifurcation.Was the approach ipsilateral or contralateral? the approach was contralateral.If contralateral, was the bifurcation angle tight? the aortic bifurcation was not steep and the sheath advanced across nicely.Details of the access sheath used (name, fr size, length)? we used a flexor 6 x 55 sheath.Was the device flushed before the procedure, as per ifu the device was flushed prior to insertion.Was resistance encountered when advancing the wire guide to the target location? the was no resistance when advancing the device to the target lesion.How did the physician deal with this resistance?.
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Event Description
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Supplemental follow-up report is being submitted to document receipt of image review.
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Manufacturer Narrative
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Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Manufacturer Narrative
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Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Lab evaluation received 09oct-2020: "inner catheter at distal end of device-cut.Distal tip of device-cut off.Wireguide at handle/along inside of device-stuck in delivery system".Previously reported: reported by the dm on behalf of the customer via complaint comm.Form - fully deployed the stent.Tried to remove the delivery system and "the system got caught on the wire" and they weren't able to pull the system off the wire.The wire was a rosen.Additional information provided by the dm on 31jul2020- just picked up the delivery system from the customer.We have a few more cases, but i¿ll try and get it mailed out today or monday at the latest.They are not able to make a cd of the case, so i had them print out a few images.I have one of the bifurcation and 4 images of the stented area both pre and post stent.Just some additional info i picked up while i was here.They pulled back so hard on the delivery system that the rosen wire somehow came unwrapped.They verified with fluoroscopy that no part of the wire went downstream and was left in the patient.Once they pulled the wire and delivery system out they cut parts of the delivery system off until they reach the wire tip.They did this for additional verification that no part of the wire was left behind in the patient.So i¿ll be sending back the delivery system, the cut off parts of the delivery system, and the rosen wire.The following has been answered- (b)(6) 29jul2020: did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? no.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.The following has been answered- (b)(6) 31jul2020: 1.What is the lot # of the device? 1.Lot#c1739937.2.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? the patient was not hospitalized.3.Is the patient confirmed covid-19 positive? or has the device made contact with anyone confirmed to be covid-19 positive? the patient has not been confirmed covid19 positive.The device did not make contact with anyone that has been confirmed covid19 positive.4.Where was the access site? the access site was left femoral artery.5.What was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.There was nothing abnormal regarding the patient anatomy.6.What was the target location for the stent? right superficial femoral artery.7.Was the target location severely calcified or tortuous? a chronic total occlusion with some calcium.8.Was the device flushed prior to use? the device was flushed prior to use.9.Were there any difficulties deploying the stent? no difficulties deploying the stent.10.Was the stent fully deployed before removing the delivery system from the patient? the stent was fully deployed.11.What other devices were used in the procedure? a 5 x 140 cook advance balloon was used to pre dilate and a 6 x 100 sterling from boston scientific was used to post dilate.Philips volcano ivus was used throughout the procedure.A.Please provide manufacturer, model, brand, and size if possible.12.Were any additional procedures necessary as a result of this event? no additional procedures were necessary.13.Can any photos, images, or reports of the procedure or device be provided? yes we can provide some pre and post images.14.Was the stent eventually deployed? the stent was deployed successfully 15.Was pre-dilatation conducted before stent deployment? the lesion was pre dilated with a 5 x 140 advance balloon.16.Was the handle pulled toward the hub while the delivery system remained stationary during deployment? the handle was pulled toward the hub while deployment.17.Was the wire guide hydrophilic or non-hydrophilic? the wire was a non- hydrophilic 0.035 rosen.18.How long was the procedure 0from advancing delivery system to the moment when the user attempted to remove the device? the stent was deployed within 2 minutes of insertion.19.Was the wire guide new or was the wire guide used previously before advancing the zilver delivery system? the same rosen wire was used to deploy the previous (2) 6 x 140 zilver ptx stents.A.If used, was the wire guide wiped between uses?.The lesion was a cto of the sfa.A total of (3) 6 x 140 zilver ptx stents were used to treat the entire sfa.With the exception of the third delivery system getting stuck on the wire after deployment the case went well and the patient received a great outcome.The following has been requested- 12aug2020.1.Could the available imaging please be forwarded to us for review.Images were printed off and returned with product *included images were the area treated, both pre and post stent.Along with an image of the bifurcation.2.Was the approach ipsilateral or contralateral? the approach was contralateral.3.If contralateral, was the bifurcation angle tight? the aortic bifurcation was not steep and the sheath advanced across nicely.4.Details of the access sheath used (name, fr size, length)? we used a flexor 6 x 55 sheath.5.Was the device flushed before the procedure, as per ifu the device was flushed prior to insertion.6.Was resistance encountered when advancing the wire guide to the target location? the was no resistance when advancing the device to the target lesion.7.How did the physician deal with this resistance?.
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Event Description
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Supplemental report being submitted due to the investigation being completed on the 09-feb-2021.
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Manufacturer Narrative
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Pma/510(k) #: p100022/s027.Annex g: g04044 - device deployer.Device evaluation: the zisv6-35-125-6-140-ptx device of lot number c1739937 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 09 october 2020.On evaluation of the device the distal tip of the device and the inner catheter at the distal end of the device were observed to be cut off as per the complaint description.A 0.035¿ wire guide was returned inside the delivery system as expected.The wire guide was stuck and could not be removed during the lab evaluation.As the wire guide remained inside the device and could not be removed, the device could not be flushed during the evaluation.Document review: prior to distribution zisv6-35-125-6-140-ptx devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for zisv6-35-125-6-140-ptx of lot number c1739937 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number ¿c1739937.It should be noted that the instructions for use (ifu0118-6) states the following: ¿following stent deployment, if resistance is met during the withdrawal of the delivery system, carefully remove the delivery system and wire guide as a unit.If resistance is still encountered during removal of the delivery system and wire guide as a unit, remove the wire guide, delivery system and introducer sheath together as a unit.¿ there is no evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression: 1.The imaging does not confirm inability to remove the delivery device over the wire.The imaging does not depict the wire.2.A wire along the mid stents could represent a piece of the rosen wire outer coil.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to congealed blood in the delivery system.It is possible that congealed blood entered the delivery system during the procedure and as the procedure progressed, the congealed blood bound the outer sheath and the wire guide together.It is possible that the congealed blood bound together resulting in the user being unable to remove the delivery system independently of the wire guide.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
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