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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 G38482 |
| Device Problems
Break (1069); Fracture (1260); Structural Problem (2506)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/23/2021 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Pma/510(k) #: p100022/s027.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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Complaint received from dm via e-mail on (b)(6) 2021.As reported to customer relations: "stenting the sfa.Was able to roll the wheel back a little bit then heard a "snapping" noise.About 10mm of the 120mm stent was exposed at this point.Opened up the handle to try and bypass the wheel and manually pull the internal metal wire that runs inside the length of the zptx deployment system.This was not successful.They then tried to pull the whole system up into the sheath.So here they are pulling on the deployment system and pushing the sheath in.This caused the stent to fracture and the exposed 10mm (approximately) to be left behind in the sfa.While the remainder of the stent and deployment system, was then removed from the sheath." additional information provided by dm on 02mar2021: "i¿d also like to get a zero dollar replacement sent out to replace this stent.Below is the info i have on the stent in question.Product description: zilver ptx stent 6mm x 120 mm 6fr g38482, lot#c1656615, expiration:3-11-21".Additional information provided by dm on 02mar2021: "how was the procedure completed? yes.Additional information provided by dm on 09mar2021: "how was the procedure completed? they completed the procedure by placing a zptx stent over the fractured zptx stent.They then used a angioplasty ballon to post dilate both stents." patient outcome: did any section of the device remain inside the patient¿s body? yes.If yes, please describe."the partial stent was then stented over with another zptx stent.This whole area was then ballooned, the ballooning went fine, the balloon did not pop." was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.If yes, please describe.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.Patient/event info notes: did any section of the device remain inside the patient¿s body? yes.If yes, please describe."the partial stent was then stented over with another zptx stent.This whole area was then ballooned, the ballooning went fine, the balloon did not pop." was the patient hospitalized or was there prolonged hospitalization due to this occurrence? no.If yes, please describe.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.
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Event Description
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Supplemental report being submitted due to additional information being added to the description of event on 22-apr-2021, the complaint device was also evaluated in the lab at cirl on 23-apr-2021 complaint received from dm via e-mail on 24feb2021--did 24feb2021.As reported to customer relations: "stenting the sfa.Was able to roll the wheel back a little bit then heard a "snapping" noise.About 10mm of the 120mm stent was exposed at this point.Opened up the handle to try and bypass the wheel and manually pull the internal metal wire that runs inside the length of the zptx deployment system.This was not successful.They then tried to pull the whole system up into the sheath.So here they are pulling on the deployment system and pushing the sheath in.This caused the stent to fracture and the exposed 10mm (approximately) to be left behind in the sfa.While the remainder of the stent and deployment system, was then removed from the sheath." additional information provided by dm on (b)(6) 2021: "i¿d also like to get a zero dollar replacement sent out to replace this stent.Below is the info i have on the stent in question: product description: zilver ptx stent 6mm x 120 mm 6fr, (b)(6), lot#c1656615, expiration:3-11-21".Additional information provided by dm on 02mar2021: "¿ how was the procedure completed? ¿ yes.Additional information provided by dm on 09mar2021: " ¿ how was the procedure completed? they completed the procedure by placing a zptx stent over the fractured zptx stent.They then used a angioplasty balloon to post dilate both stents." additional information provided by dm on 22apr2021: "¿ it is indicated that ¿upon initial deployment, note is made of a crack, which indicates that the stent has been released from the mechanism¿¿ is it believed that this crack is the ¿¿snapping¿¿ noise mentioned in the event description? correct.During wheel deployment, after about a single wheel turn, note was made of a loud snapping/cracking noise.Since one wheel turn the stent was partially deployed, but no longer would deploy with the turning of the wheel thereafter.Details of the wire guide used (name, diameter, hyrdophyllic)? 0.035 wire.Either amplatz/glidewire advantage (non hydrophilic).¿ was the wire guide removed from the patient prior to advancing the delivery system? no.Not sure how this is even possible, you have to track the stent over a wire.¿ was resistance encountered when advancing the wire guide? not really.The sheath itself had a lot of stress on it due to tortous iliacs, and was very difficult to advance (the sheath), but the stent went relatively straightforward into the area of concern.¿ did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? unclear what this means.Again the tension was removed from the stent deployment but retracting it after i positioned it distal to the lesion.I then started the wheel, everything going well but after 1 wheel turn, the click noise was heard, and the wheel no longer was unsheathing the stent as the metal wire inside the catheter had broken (which i later found out).¿ was the delivery system itself kink or twist during advancement or deployment? its possible the delivery system was twisted due to the tortuosity of the sheath, but unlikely to be kinked.I did take the tension out by retracting it prior to delivery though.This would not necessarily have taken out the torque however." patient outcome: 1.Did any section of the device remain inside the patient¿s body? yes if yes, please describe."the partial stent was then stented over with another zptx stent.This whole area was then ballooned, the ballooning went fine, the balloon did not pop." 2.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? ¿ no.3.Did the patient require any additional procedures due to this occurrence? no.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: 1.0 examples of rpn prefixes (but not limited to): zib5, zib6, ziv5, zisv6, zvt7, ziv6.1.1 general questions for complaint occurring during use, request the following: 1.2 where was the access site? ¿ left cfa.1.3 what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.¿ calcified.1.4 what was the target location for the stent? ¿ sfa.Was the target location severely calcified or tortuous? ¿ yes.1.5 was the device flushed prior to use? ¿ yes.1.6 were there any difficulties deploying the stent? ¿ yes - upon initial deployment, note is made of a crack, which indicates that the stent has been released from the mechanism, however this was premature as only 2 cm of the stent was deployed in the distal sfa.The representative was contacted who advised attempting to manually pulled a string after opening the device, however after opening the device, the string was detached and broken.1.7 was the stent fully deployed before removing the delivery system from the patient? ¿ no.1.8 what other devices were used in the procedure? please provide manufacturer, model, brand, and size if possible.¿ cook 6fr 45cm sheath, ¿ 6french pioneer plus reentry catheter, ¿ 6 mm spider filter, ¿ turbo laser atherectomy spectranetics.¿ multiple cook balloons.
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Manufacturer Narrative
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Pma/510(k) #: p100022/s027.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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Supplemental report is being submitted due to the completion of the investigation.
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Manufacturer Narrative
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Device evaluation the zisv6-35-125-6-120-ptx device of lot number c1656615 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 (b)(6) 2021.(b)(4).The returned device lab examination findings and observations can be referred through attached photos (ref att.(b)(4)).On evaluation of the device approximately 2.9cm of stent deployed and fractured at the distal end of the stent.The retraction wire was separated from the stent retraction sheath.The wire guide from the procedure was returned in the dismantles device.The device was unable to be flushed or wire guide pass through the device during evaluation.The device was returned dismantled as expected.The retraction wire separated from the stent retraction sheath (srs) per event description.Stent partially deployed on return.As per additional information approximately 2.9 cm of stent fractured in patient.Document review prior to distribution zisv6-35-125-6-120-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 zisv6-35-125-6-120-ptx of lot number c1656615 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 or there is no evidence to suggest that there are any manufacturing issues associated with lot number c1656615.It should be noted that the instructions for use (ifu118-5) states the following: do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.There is no evidence to suggest the user did not follow the ifu.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 difficult patient anatomy.It is possible that difficult patient anatomy contributed to resistance during attempted deployment.The resistance likely caused the retraction wire to separate resulting in the user attempting to manually deploy the stent.When the user could not deploy the stent and removed the device the partially deployed stent fractured.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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Manufacturer Narrative
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Device evaluation: the zisv6-35-125-6-120-ptx device of lot number c1656615 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 (b)(6)2021.On evaluation of the device approximately 2.9cm of stent deployed and fractured at the distal end of the stent.The retraction wire was separated from the stent retraction sheath.The wire guide from the procedure was returned in the dismantles device.The device was unable to be flushed or wire guide pass through the device during evaluation.The device was returned dismantled as expected.The retraction wire separated from the stent retraction sheath (srs) per event description.Stent partially deployed on return.As per additional information approximately 2.9 cm of stent fractured in patient.Document review: prior to distribution zisv6-35-125-6-120-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 zisv6-35-125-6-120-ptx of lot number c1656615 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 or there is no evidence to suggest that there are any manufacturing issues associated with lot number c1656615.It should be noted that the instructions for use (ifu118-5) states the following: do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.There is no evidence to suggest the user did not follow the ifu.Image review n/a : 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 difficult patient anatomy.It is possible that difficult patient anatomy contributed to resistance during attempted deployment.The resistance likely caused the retraction wire to separate resulting in the user attempting to manually deploy the stent.When the user could not deploy the stent and removed the device the partially deployed stent fractured.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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Event Description
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Supplemental report is being submitted due to the completion of the investigation on 24-aug-2023.
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