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COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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| Catalog Number ZISV6-35-125-7-120-PTX |
| Device Problems
Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Pain (1994); No Code Available (3191)
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| Event Date 04/27/2018 |
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Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) #p100022/s014.(b)(4).(b)(6).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.
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Event Description
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Initial mdr is being submitted based on the requirement for a surgical intervention.The image review noted that the stent in this (b)(4) was not fractured however it may have caused or contributed to the fracture.As reported to customer relations "the patient had 3 each of g38490 and 1 each of g38488 implanted on (b)(6) 2017.In the radiograph performed on (b)(6) 2018, it appeared that one each of g38490 ((b)(4)) and g38488 ((b)(4)) was damaged and torn in half.The fracture is occurring proximally.The patient is coming back on (b)(6) 2018 for re-intervention and more will be reported at that time.".
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Manufacturer Narrative
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Pma/510(k) #p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Problem statement: as reported to customer relations "the patient had 3 each of g38490 and 1 each of g38488 implanted on (b)(6) 2017.In the radiograph performed on (b)(6) 2018, it appeared that one each of g38490 (pr226125) and g38488 ((b)(4)) was damaged and torn in half.The fracture is occurring proximally.The patient is coming back on (b)(6) 2018 for re-intervention and more will be reported at that time." add'l information provided by dm on 12jun2018: "only the proximal stent is fractured, the distal one is not.(b)(6) covered the 23may2018 case (dm was on vacation), but (b)(6) didn't know much beyond they performed an arteriogram and they will have to do a surgical intervention at a later date, and their plan is to surgically excise half of the broken stent (leaving 1 strut still attached).Physician confirmed that proximal stent tore in half, migrated and occluded the profunda.(b)(6) asked the physician about his thoughts on the product; physician said he'd never seen a stent fracture in this manner.However, the physician will continue to use the device line (reportedly)" additional information provided by dm on 12jun2018: "(b)(6) communicated they plan to intervene surgically on this patient this thursday, (b)(6) 2018." device evaluation: the zisv6-35-125-7-120-ptx device of unknown lot number involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.There are two devices and complaint files related to this occurrence.Refer to file pr 226343 for details of the second device.The customer stated that the patient will undergo surgery to treat the fractured stent, and additional information will be available afterwards.It is known that the patient had pre-existing conditions, including current smoker and pad (peripheral arterial disease).The customer was contacted to confirm if an intervention was conducted, and the patient outcome.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.Is the complaint confirmed? no.Type iv fracture of the zisv6-35-125-7-80-ptx ((b)(4)) is confirmed while fracture of the zisv6-35-125-7-120-ptx ((b)(4)) is not.Observation of device effects, relative to the patient's anatomy: the fracture occurred where hip flexion and sfa redundancy, evident in the angles, repeatedly kinked and stretched the stent until it fractured.The double stent of the overlap focused angulation and kinking at its end rather than gradually dissipating the curvature as was observed at the mid stent overlap.Observation of device effects, relative to the disease state: none.Observation of significant findings relative to the use of the device: none.Observation of additional device findings relative to the clinical perspective: none.Findings: a single, proximal right thigh x-ray is provided along with the complaint report.Two stents in the expected location of the proximal right sfa (superficial femoral artery) are overlapped 31 mm.Although whether a shorter stent was completely inside a longer stent or a shorter stent was projecting superior from a longer stent cannot be determined on the image.The stents noted in the complaint support a zisv6-35-125-7-120-ptx as the more distal stent with zisv6-35-125-7-80-ptx projecting out of its superior end.Assuming the zisv6-35-125-7-80-ptx as the more proximal stent, it was 75mm long and transversely fractured at the superior end of the zisv6-35-125-7 -120-ptx.Where it extended superiorly out of the zisv6-35-125-7-120-ptx, the zisv6-35-125-7 -80-ptx was transversely fractured with one stent element row stretched across the fracture, consistent with a type iv fracture.The 20mm long superior stent fragment, 8.5mm diameter, indicated anterior to posterior compression.The intervening stent row was stretched 7mm across the fracture site where the sfa angled 30 degrees.The mid overlapped stent segment angled 12 degrees opposite the angulation at the fracture.The 30mm, rather than 10-15mm stent overlap at the proximal end of the stented segment, is not uncommon as the available stent size is matched to the remaining artery segment requiring stenting.To provide as much flexibility as possible at the proximal end, the more distal stents are usually only overlapped 10-15mm.Consequently, overall stented length was likely 35-37cm.Such a long segment was bound to experience at least bending as likely twisting and elongation of the sfa with hip and or knee flexion.Surgical clips are consistent with the reported aorto-bifemoral bypass.Impression: type iv fracture of the zisv6-35-125-7 -80-ptx ((b)(4)) is confirmed while fracture of the zisv6-35-125-7-120-ptx ((b)(4)) is not.The fracture occurred where hip flexion and sfa redundancy, evident in the angles, repeatedly kinked and stretched the stent until it fractured.The double stent of the overlap focused angulation and kinking at its end rather than gradually dissipating the curvature as was observed at the mid stent overlap.Complaint is not confirmed as the defect could not be verified in the image(s).The complaint stent was not observed to be fractured in the images.The customer provided additional images of the implanted stent.The investigation will be updated once the images have been reviewed.There is no evidence to suggest the customer did not follow the product instructions for use.Document review: as per internal procedures, for complaints involving positive/ negative feedback, or where it has been determined either through the manufacturer or through clinical opinion that the device functionality did not contribute to the issue, a limited investigation may be completed.Therefore a review of the work order is not required.Summary: complaint is not confirmed as the defect could not be verified in the image(s).The complaint stent was not observed to be fractured in the images.As per internal procedures, complaints which are not confirmed will not be assessed for risk since there is no failure mode to assess.According to the initial reporter, the patient experienced right groin paint 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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This follow up mdr is being submitted to update the investigation results.Initial mdr submitted based on the requirement for a surgical intervention.The image review noted that the stent in this ((b)(4)) was not fractured however it may have caused or contributed to the fracture.As reported to customer relations "the patient had 3 each of g38490 and 1 each of g38488 implanted on (b)(6) 2017.In the radiograph performed on (b)(6) 2018, it appeared that one each of g38490 ((b)(4)) and g38488 ((b)(4)) was damaged and torn in half.The fracture is occurring proximally.The patient is coming back on (b)(6) 2018 for re-intervention and more will be reported at that time.".
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Event Description
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Mdr submitted based on the requirement for a surgical intervention.As reported to customer relations "the patient had 3 each of g38490 and 1 each of g38488 implanted on 14jun2017.In the radiograph performed on (b)(6) 2018, it appeared that one each of g38490 ((b)(4)) and g38488 ((b)(4)) was damaged and torn in half.The fracture is occurring proximally.The patient is coming back on (b)(6) 2018 for re-intervention and more will be reported at that time." add'l information provided by dm on (b)(6) 2018: "only the proximal stent is fractured, the distal one is not.(b)(6) covered the (b)(6) 2018 case (dm was on vacation), but (b)(6) didn't know much beyond they performed an arteriogram and they will have to do a surgical intervention at a later date, and their plan is to surgically excise half of the broken stent (leaving 1 strut still attached).Physician confirmed that proximal stent tore in half, migrated and occluded the profunda.The image review noted that the stent in this pr ((b)(4)) was not fractured however it may have caused or contributed to the fracture.The stent overlap was in excess of 30mm which is beyond the recommended 10-15mm.This file will remain reportable based on the need for surgical intervention.Additional information provided by dm on 12jun2018: "dr.(b)(6) communicated the plan to intervene surgically on this patient this thursday, (b)(6) 2018.He did want to request some information from cook regarding reimbursement/payment for the additional procedures for this patient.
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Manufacturer Narrative
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Pma/510(k) #p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).(b)(4).Importer site establishment registration number: (b)(4).Problem statement as reported to customer relations "the patient had 3 each of g38490 and 1 each of g38488 implanted on (b)(6) 2017.In the radiograph performed on (b)(6) 2018, it appeared that one each of g38490 ((b)(4)) and g38488 ((b)(4)) was damaged and torn in half.The fracture is occurring proximally.The patient is coming back on (b)(6) 2018 for re-intervention and more will be reported at that time." add'l information provided by dm on 12jun2018: "only the proximal stent is fractured, the distal one is not.Marcus carr covered the (b)(6) 2018 case (dm was on vacation), but marcus didn't know much beyond they performed an arteriogram and they will have to do a surgical intervention at a later date, and their plan is to surgically excise half of the broken stent (leaving 1 strut still attached).Physician confirmed that proximal stent tore in half, migrated and occluded the profunda.(b)(6) asked the physician about his thoughts on the product; physician said he'd never seen a stent fracture in this manner.However, the physician will continue to use the device line (reportedly)" additional information provided by dm on 12jun2018: "dr.(b)(6) communicated they plan to intervene surgically on this patient this thursday, (b)(6) 2018." device evaluation: the zisv6-35-125-7-120-ptx device of unknown lot number involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.There are two devices and complaint files related to this occurrence.The customer stated that the patient will undergo surgery to treat the fractured stent, and additional information will be available afterwards.It is known that the patient had pre-existing conditions, including current smoker and pad (peripheral arterial disease).The customer was contacted to confirm if an intervention was conducted, and the patient outcome.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.Type iv fracture of the zisv6-35-125-7 -80-ptx ((b)(4)) is confirmed while fracture of the zisv6-35-125-7-120-ptx ((b)(4)) is not.2.The fracture occurred where hip flexion and sfa redundancy, evident in the angles, repeatedly kinked and stretched the stent until it fractured.The double stent of the overlap focused angulation and kinking at its end rather than gradually dissipating the curvature as was observed at the mid stent overlap.3.Additional imaging from the implantation procedure and subsequent secondary interventions demonstrated fracture fragment displacement 7mm into the cfa and pfa occlusion.Although the fracture fragment was removed, it did not directly impinge on the pfa ostium.Although organized mural thrombus occluding the pfa could have been aggravated by the fragment, this was not stated or implied in the operative notes.Complaint is not confirmed as the defect could not be verified in the image(s).The complaint stent was not observed to be fractured in the images.Additional imaging provided by the customer demonstrated the displacement of the fractured fragment of the zisv6-35-125-7-80-ptx stent.The thrombus that occluded the pfa could have been aggravated by the fragment but this is unlikely as it was not mentioned in the operative notes.There is no evidence to suggest the customer did not follow the product instructions for use (ifu0118-3).As the complaint stent for this complaint file was not returned for evaluation, as the fracture/damage was not observed from the images provided and as circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.Summary: complaint is not confirmed as the defect could not be verified in the image(s).The complaint stent was not observed to be fractured in the images.Complaints which are not confirmed will not be assessed for risk since there is no failure mode to assess.According to the initial reporter, the patient experienced right groin paint due to this occurrence.
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Event Description
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Mdr submitted based on the requirement for a surgical intervention.As reported to customer relations "the patient had 3 each of g38490 and 1 each of g38488 implanted on (b)(6) 2017.In the radiograph performed on 27apr2018, it appeared that one each of g38490 ((b)(4)) and g38488 ((b)(4)) was damaged and torn in half.The fracture is occurring proximally.The patient is coming back on (b)(6) 2018 for re-intervention and more will be reported at that time.".
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Manufacturer Narrative
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Pma/510(k) #p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
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