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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 Problem
Material Deformation (2976)
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| Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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| Event Date 12/03/2019 |
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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.Pma/510(k) # p100022/s026.
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Event Description
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Per complaint email: antegrade stick to the left leg using a 6fr 10cm sheath (company not specified).From distal to proximal the following stents were placed in the sfa: 6x100, 6x140, 7x140, 7x120, 7x60.The three stents in the middle (6x140, 7x140, 7x120) all did not deploy correctly.In the image, the stents looked like they were crunched up and not fully deployed.However both of the stents distal and proximal deployed just fine.There were all deployed in the left sfa.The patient did not have any further complications or any longer of hospital stay, the outcome looked fine except he had to use 5 stents instead of 3.(b)(4) ¿ 7x120 lot c1547234 [(b)(4)].(b)(4) ¿ 6x140 lot c1657393 [(b)(4)].(b)(4) ¿ 7x140 lot c1577799 [(b)(4)].
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Manufacturer Narrative
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Pma/510(k) # p100022/s026.Device evaluation the zisv6-35-125-6-140-ptx device of lot number c1657393 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.A number of attempts were made to obtain additional information regarding this event.However, at the time of the investigation a response had not been received.Should any additional information be made available to cirl the investigation will be updated accordingly.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 09 january 2020.On evaluation of the device no visual defects were observed on the device.The stent was not returned as per the complaint description.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 c1657393 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 c1657393.It should be noted that the instructions for use (ifu0118-5) instructs the user to ensure the distal end of the stability sheath is inside the access sheath.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, the user moving the delivery system during deployment and/or the distal end of the stability sheath being held outside of the access sheath during deployment.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any complications or require an extended hospital stay.However, the patient did receive 02 extra stents as a result of this event.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Per complaint email: antegrade stick to the left leg using a 6fr 10cm sheath (company not specified).From distal to proximal the following stents were placed in the sfa: 6x100, 6x140, 7x140, 7x120, 7x60.The three stents in the middle (6x140, 7x140, 7x120) all did not deploy correctly.In the image, the stents looked like they were crunched up and not fully deployed.However both of the stents distal and proximal deployed just fine.There were all deployed in the left sfa.The patient did not have any further complications or any longer of hospital stay, the outcome looked fine except he had to use 5 stents instead of 3.G38490 ¿ 7x120 lot c1547234 [(b)(4)].G38483 ¿ 6x140 lot c1657393 [(b)(4)].G38491 ¿ 7x140 lot c1577799 [(b)(4)].
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Manufacturer Narrative
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Pma/510(k) # p100022/s026.Device evaluation: it should be noted that this file relates to pr 286445 and pr 286451.Each file investigates the same issue whereby the stent appeared crunched up and not fully deployed.The zisv6-35-125-6-140-ptx device of lot number c1657393 involved in this complaint was returned for evaluation, without the original packaging.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 january 2020.On evaluation of the device no visual defects were observed on the device.The stent was not returned as per the complaint description.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 c1657393 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 c1657393.It should be noted that the instructions for use (b)(4) instructs the user to ensure the distal end of the stability sheath is inside the access sheath.There is evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could be attributed to the user not placing the distal end of the stability sheath inside the access sheath during deployment.Not inserting the distal end of the stability sheath into the access sheath can result in the delivery system not being adequately held in place or supported during deployment.This can lead to the more sudden release of the stent from the delivery system causing it to bunch up on itself.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any complications or require an extended hospital stay.However, the patient did receive 02 extra stents as a result of this event.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Per complaint email: antegrade stick to the left leg using a 6fr 10cm sheath (company not specified).From distal to proximal the following stents were placed in the sfa: 6x100, 6x140, 7x140, 7x120, 7x60.The three stents in the middle (6x140, 7x140, 7x120) all did not deploy correctly.In the image, the stents looked like they were crunched up and not fully deployed.However both of the stents distal and proximal deployed just fine.There were all deployed in the left sfa.The patient did not have any further complications or any longer of hospital stay, the outcome looked fine except he had to use 5 stents instead of 3.G38490 ¿ 7x120 lot c1547234 [(b)(4)].G38483 ¿ 6x140 lot c1657393 [(b)(4)].G38491 ¿ 7x140 lot c1577799 [(b)(4)].1.Are images of the device of procedure available? rep took some photos on phone, will try to get sent if more needed 2.Was the approach ipsilateral or contralateral? contralateral 3.If contralateral, was the bifurcation angle tight? no 4.Was pre-dilation performed ahead of placement of the stent? yes 5.Was post-dilation performed after the placement of the stent? yes 6.Details of the wire guide used (name, diameter, hyrdophyllic)? bentson, 035 7.Details of the access sheath used (name, fr size, length)? 6f, 45cm ansel 8.Was the device flushed before the procedure, as per ifu yes 9.What was the target location for the complaint device? sfa 10.Was the patient's anatomy tortuous or calcified? calcified- moderate 11a.Was resistance encountered when advancing the wire guide to the target location? how did the physician deal with this resistance? no 11b.Was resistance encountered when advancing the delivery system to the target location? how did the physician deal with this resistance? no 12.Did the stent delivery system cross the target location? yes 13.What artery was the stent placed in? sfa 14.Was the stability sheath inside the access sheath during deployment? no 15.Was the retraction sheath being held during deployment? no 16.Was the device held straight during deployment? yes post lab evaluation questions: 1.What does the user mean by "crunched up"? does this mean the compressed longitudinally, does it mean they didn't appose to the vessel wall correctly or does it mean something else? please provide a clear description of this so we can understand what occurred with the device.Device did not deploy to stated length, deployed with somewhat "stacked" appearance.2.Were the stents overlapped with one another? yes.3.Was the delivery system moved during deployment? no.4.Was the delivery system held taut and straight during deployment? yes, held the same as 100's of other deployments which had no issues before or after.
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