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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 G38415 |
| Device Problems
Break (1069); Structural Problem (2506)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/09/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Pma/510(k) #: p100022/s001
(b)(4)
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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As initially reported to customer relations via phone conversation with district manager:
a patient of undisclosed age and gender underwent a femoral popliteal stenting procedure in which the zilver ptx 35 drug-eluting stent, g38415, was used.The physician went to deploy the stent and upon deployment the thumb-wheel broke and had to break the casing to hand deploy.The stent got stuck and only partially deployed.The physician was able to retract the stent into the sheath and remove the device.Another of the same device was used to complete the procedure.Patient outcome:
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.Patient/event info - notes:
1.0 examples of rpn prefixes (but not limited to):
¿ zib5 ¿ zib6 ¿ ziv5
¿ zisv6 ¿ zvt7 ¿ ziv6
general questions for complaint occurring during use, request the following:
where was the access site?
what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.What was the target location for the stent?
was the target location severely calcified or tortuous?
was the device flushed prior to use?
were there any difficulties deploying the stent?
was the stent fully deployed before removing the delivery system from the patient?
what other devices were used in the procedure?
please provide manufacturer, model, brand, and size if possible.Were any additional procedures necessary as a result of this event?
can any photos, images, or reports of the procedure or device be provided?.
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Manufacturer Narrative
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Pma/510(k) #: p100022/s001.Annex g: g04044 - device deployer.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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This is a supplemental report being submitted for the return of device and lab evaluation completed on 19-mar-21.The investigation is still on going.As initially reported to customer relations via phone conversation with district manager: a patient of undisclosed age and gender underwent a femoral popliteal stenting procedure in which the zilver ptx 35 drug-eluting stent, (b)(6), was used.The physician went to deploy the stent and upon deployment the thumb-wheel broke and had to break the casing to hand deploy.The stent got stuck and only partially deployed.The physician was able to retract the stent into the sheath and remove the device.Another of the same device was used to complete the procedure.Patient outcome: 1.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization? no.3.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no.If yes, please specify additional procedures and provide details.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.Please specify adverse effects and provide details.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? 1.3 what was the patient¿s anatomy? i.E.Scarred, tortuous, calcified, etc.1.4 what was the target location for the stent? was the target location severely calcified or tortuous? 1.5 was the device flushed prior to use? 1.6 were there any difficulties deploying the stent? 1.7 was the stent fully deployed before removing the delivery system from the patient? 1.8 what other devices were used in the procedure? please provide manufacturer, model, brand, and size if possible.1.9 were any additional procedures necessary as a result of this event? 1.10 can any photos, images, or reports of the procedure or device be provided?.
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Manufacturer Narrative
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Pma/510(k) #: p100022/s001.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 being submitted due to answers to additional questions being received on 20-apr-2021.As initially reported to customer relations via phone conversation with district manager: a patient of undisclosed age and gender underwent a femoral popliteal stenting procedure in which the zilver ptx 35 drug-eluting stent, g38415, was used.The physician went to deploy the stent and upon deployment the thumb-wheel broke and had to break the casing to hand deploy.The stent got stuck and only partially deployed.The physician was able to retract the stent into the sheath and remove the device.Another of the same device was used to complete the procedure.Patient outcome: 1.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization? no.3.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.4.Did the product cause or contribute to the need for additional procedures? no.If yes, please specify additional procedures and provide details.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.Please specify adverse effects and provide details.Patient/event info - notes: 1.Are images (e.G.Angiography, us etc.) of the device and/or procedure available? no.2.Was the device flushed before the procedure, as per ifu? yes.3.Were there any issues with flushing of the device? no.4.Details of the access sheath used (name, fr size,length)? 6fr x 45 flexor.5.Details of the wire guide used (name, diameter, hyrdophyllic)?.035 glidewire.6.What approach was used to access the target site? contralateral.Please specify for other: 7.If contralateral, was the bifurcation angle steep? no.8.What was the target location for the stent? sfa.9.What artery was the stent placed in? distal sfa.Please specify for other: 10.Was the wire guide removed from the patient prior to advancing the delivery system? no.11.If removed, was the wire guide wiped prior to advancement of the delivery system? n/a, yes, no.12.Did the stent delivery system cross the target location? yes.13.Was pre-dilation performed ahead of placement of the stent? n/a.14.Was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other if other, please specify: 15.Was resistance encountered when advancing the wire guide? n/a.16.Was resistance encountered when advancing the delivery system to the target location? n/a.17.Was resistance encountered when deploying the stent? yes.18.How did the physician deal with any resistance encountered? 19.Was the stent fully deployed in the patient before removing the delivery system? n/a 20.After deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other.If other please specify: 21.Was post-dilation performed after the placement of the stent? n/a.22.Did any portion of the device break off? n/a.If yes please state what part: 23.When did the device break? deployment.24.Thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? n/a, yes, no.25.Thumbwheel only ¿ was the retraction sheet being held during deployment.N/a, yes, no.26.Did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? n/a, yes, no.27.If yes, was the stent partially deployed? n/a, yes, no.28.If yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a, removed, deployed.29.If removed, did any part of the stent fracture during removal of the delivery system? n/a, yes, no.30.Was the delivery system kinked or twisted during advancement or deployment? n/a, yes, no.31.Please advise if and when any damage was observed on the; wireguide n/a, yes, no.Prior to use, during use, post procedure.Delivery system n/a, yes, no.Prior to use, during use, post procedure.If yes, please specify (e.G.Kinked or twisted): 32.Did the patient require any additional procedures as a result of this event? n/a, yes, no.33.What intervention (if any) was required? 34.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.35.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no.36.Please specify if yes.37.Did the observe the kink on the proximal inner prior to returning the device ?.
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Manufacturer Narrative
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Pma/510(k) #: p100022/s001.Device evaluation the zisv6-35-125-5-120-ptx device of lot number c1764403 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 19th march 2021.On evaluation of the device a kink was observed approximately 6.1 cm from the flla hub on the proximal inner.At the distal white tip partial sent deployment of 1.7cm was observed.At the distal end of the access sheath 1.7 cm of fractured stent was observed.Document review: prior to distribution zisv6-35-125-5-120-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 zisv6-35-125-5-120-ptx of lot number c1764403 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has or 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 c1764403.It should be noted that the instructions for use (ifu118-6) 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 when 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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Hold for cm 11/8
final mdr being submitted due to completion of the investigation on 17-nov-2021.
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Manufacturer Narrative
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Pma/510(k) #: p100022/s001.Device evaluation: the zisv6-35-125-5-120-ptx device of lot number c1764403 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 19th march 2021.Refer to attachment¿s (b)(4)._lab attendance and (b)(4)._lab evaluation notes for lab attendance and notes.The returned device lab examination findings and observations can be referred through attached photos.On evaluation of the device a kink was observed approximately 6.1 cm from the flla hub on the proximal inner.At the distal white tip partial sent deployment of 1.7cm was observed.At the distal end of the access sheath 1.7 cm of fractured stent was observed.Document review: prior to distribution zisv6-35-125-5-120-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 zisv6-35-125-5-120-ptx of lot number c1764403 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has or 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 c1764403.It should be noted that the instructions for use (ifu118-6) 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 when 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 correction mdr is being submitted due to below changes: medical device problem code (annex a) changed from "a0511 - structural problem" to "a0401 - break".
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