|
COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
|
Back to Search Results |
|
| Catalog Number ZISV6-35-125-5.0-80-PTX |
| Device Problems
Occlusion Within Device (1423); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
|
| Patient Problems
Reocclusion (1985); No Consequences Or Impact To Patient (2199)
|
| Event Date 10/30/2017 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
(b)(4).(b)(6).(b)(4).The investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.
|
| |
|
Event Description
|
|
Brief description ¿ occlusion/stenosis in the study leg.On (b)(6) 2017 during the index procedure the patient received two zilver© ptx© stents.The study lesion was in the left proximal and distal sfa.The lesion status was de novo and there was no calcification or thrombus observed pre-procedure.The inflow tract was patent and there was one runoff vessel.The lesion length was 200 mm and the proximal rvd was 5.10 mm and distal rvd was 5 mm.The percentage diameter stenosis in study lesion was (b)(4)%.The post-procedure imaging showed (b)(4)% diameter stenosis left in the study lesion.This has been queried.On (b)(6) 2017 (80 days post-procedure), the patient was hospitalized for an occlusion of the right (non-study leg) femoral artery.A ilio-femoral bypass was performed.This was not related to device or procedure.On (b)(6) 2017 (184 days post-procedure), a stenosis of the right femoral artery and femoropopliteal bypass was revealed.This was treated with placement of a stent.On (b)(6) 2017 (194 days post-procedure), a follow-up visit revealed a study leg rutherford classification of 3.The study lesion was occluded.On (b)(6) 2017 (298 days post-procedure), an occlusion of the left sfa was revealed.Angiography revealed (b)(4)% stenosis.This was treated with an endovascular procedure where a stent was placed.No device malfunction was noted but the event was thought to be definitely related to the device.The relationship to the procedure was unknown.No pre-existing condition caused this.On (b)(6) 2018 (368 days post-procedure), a follow-up visit revealed a study leg rutherford classification of 0.The study lesion was patent.As two devices are involved in this event a separate report has been submitted for each device.Refer also to report # 3001845648-2018-00044.
|
| |
|
Event Description
|
|
This follow up report is being submitted to update the investigation results update as follows: the customer clarified that on the (b)(6) 2017, the percentage diameter stenosis in study lesion was 100%, not 3% as stated in the event description.The clinical research specialist also stated that this occurrence was likely due to restenosis, not thrombosis, as the customer did not specifically indicate thrombosis, nor did the physician perform a thrombectomy or thrombolysis.As two devices are involved in this event a separate report has been submitted for each device.Refer also to report # 3001845648-2018-00044.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).Exemption number: e2016031.(b)(4).Problem statement brief description: occlusion/stenosis in the study leg.On (b)(6) 2017 during the index procedure the patient received two zilver© ptx© stents.The study lesion was in the left proximal and distal sfa.The lesion status was de novo and there was no calcification or thrombus observed pre-procedure.The inflow tract was patent and there was one runoff vessel.The lesion length was 200 mm and the proximal rvd was 5.10 mm and distal rvd was 5 mm.The percentage diameter stenosis in study lesion was 3 %.The post-procedure imaging showed 80 % diameter stenosis left in the study lesion.This has been queried.On (b)(6) 2017 ¿ (b)(6) 2017 (80 days post-procedure), the patient was hospitalized for an occlusion of the right (non-study leg) femoral artery.A ilio-femoral bypass was performed.This was not related to device or procedure.On (b)(6) 2017 (184 days post-procedure), a stenosis of the right femoral artery and femoropopliteal bypass was revealed.This was treated with placement of a stent.On (b)(6) 2017 (194 days post-procedure), a follow-up visit revealed a study leg rutherford classification of 3.The study lesion was occluded.On (b)(6) 2017 ¿ (b)(6) 2017 (298 days post-procedure), an occlusion of the left sfa was revealed.Angiography revealed 85 % stenosis.This was treated with an endovascular procedure where a stent was placed.No device malfunction was noted but the event was thought to be definitely related to the device.The relationship to the procedure was unknown.No pre-existing condition caused this.On (b)(6) 2018 (368 days post-procedure), a follow-up visit revealed a study leg rutherford classification of 0.The study lesion was patent." device evaluation the zisv6-35-125-5.0-80-ptx of lot number c1243651 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 event.Refer to complaint file (b)(4) for details of the second device (zisv6-35-125-5.0-120-ptx device of lot number c1287834).From customer testimony, it is known that the patient had a history of hypertension, hypercholesterolemia and is a current smoker.The study leg had a rutherford classification of three and the patient was taking aspirin and clopidogrel pre-procedurally.The customer was contacted to request images of the procedure.At the time of the investigation, the images had not been provided.The investigation will be updated once the images have been made available.The customer clarified that on the (b)(6) 2017, the percentage diameter stenosis in study lesion was 100%, not 3% as stated in the event description.The clinical research specialist also stated that this occurrence was likely due to restenosis, not thrombosis, as the customer did not specifically indicate thrombosis, nor did the physician perform a thrombectomy or thrombolysis.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.From the information provided, it is known that the patient had risk factors for restenosis, including smoking and prior history of hypertension and hypercholesterolemia.However, as images of the stent have not been provided, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.As per the product instruction for use, restenosis of the stented artery is listed under potential adverse effects.Document review prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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.Summary there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk was determined to be low (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient received another stent to treat the occluded vessel.Complaints of this nature will continue to be monitored for potential emerging trends.
|
| |
|
Event Description
|
|
This follow up is being submitted to update the investigation following additional information (receipt of images and image review 09-nov-2018).Brief description: reason for trackwise entry ¿ occlusion/stenosis in the study leg.On (b)(6) 2017 during the index procedure the patient received two zilver© ptx© stents.The study lesion was in the left proximal and distal sfa.The lesion status was de novo and there was no calcification or thrombus observed pre-procedure.The inflow tract was patent and there was one runoff vessel.The lesion length was 200 mm and the proximal rvd was 5.10 mm and distal rvd was 5 mm.The percentage diameter stenosis in study lesion was 3 %.The post-procedure imaging showed 80 % diameter stenosis left in the study lesion.This has been queried.On (b)(6) 2017 (80 days post-procedure), the patient was hospitalized for an occlusion of the right (non-study leg) femoral artery.A ilio-femoral bypass was performed.This was not related to device or procedure.On (b)(6) 2017 (184 days post-procedure), a stenosis of the right femoral artery and femoropopliteal bypass was revealed.This was treated with placement of a stent.On (b)(6) 2017 (194 days post-procedure), a follow-up visit revealed a study leg rutherford classification of 3.The study lesion was occluded.On (b)(6) 2017 (298 days post-procedure), an occlusion of the left sfa was revealed.Angiography revealed 85 % stenosis.This was treated with an endovascular procedure where a stent was placed.No device malfunction was noted but the event was thought to be definitely related to the device.The relationship to the procedure was unknown.No pre-existing condition caused this.On (b)(6) 2018 (368 days post-procedure), a follow-up visit revealed a study leg rutherford classification of 0.The study lesion was patent.
|
| |
|
Manufacturer Narrative
|
|
Pma/510(k) # = this specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore mdr reporting criteria applicable to this event.Section h exemption: 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: (b)(4).This follow up is being submitted to update the investigation following additional information (receipt of images and image review 09-nov-2018).Device evaluation: the zisv6-35-125-5.0-80-ptx of lot number c1243651 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 event.Refer to complaint file pr 214526 for details of the second device (zisv6-35-125-5.0-120-ptx device of lot number c1287834).Document review: prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records (b)(4) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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 c1243651.It may be noted that the instructions for use lists restenosis of the stented artery as a known potential adverse effect.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: moderate stenosis from neointimal hyperplasia (nih) in proximal end of the zisv6-35-125-5.0-80-ptx and the distal end of the zisv6-35-125-5.0-120-ptx is confirmed.The hyperplasia was promoted by insufficient overlap with a third stent implanted just superior to the zisv6-35-125-5.0-80-ptx, progressive greater than 50% inflow stenosis of the cfa, and the reported tobacco abuse.Because a third larger diameter stent was implanted flush with the zisv6-35-125-5.0-80-ptx superior end rather than overlapped into the zisv6-35-125-5.0- 80-ptx, the sfa at this location would have been irritated by the differing stent diameters, the ends of the stents, and unsupported bending and twisting.Apart from smooth as opposed to sharp stent ends, the lack of overlap essentially functioned as a stent fracture.This irritation would have provoked nih.A new 65% stenosis of the left cfa, possibly provoked by continued tobacco abuse, increased the probability of nih by significantly limiting inflow.Root cause review: a definitive root cause of neointimal hyperplasia (nih) was identified within the imaging review.The nih was promoted by insufficient overlap of a third stent that was implanted superiorly to the zisv6-35-125-5.0-80-ptx, progressive greater than 50% inflow stenosis of the cfa and the reported tobacco abuse.Summary: complaint is confirmed as the failure was verified in the image(s).Moderate stenosis from neointimal hyperplasia (nih) was confirmed in the proximal end of the zisv6-35-125-5.0-80-ptx stent and in the distal end of the zisv6-35-125-5.0-120-ptx stent.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient received another stent to treat the occluded vessel.Complaints of this nature will continue to be monitored for potential emerging trends.
|
| |
|
Manufacturer Narrative
|
|
This specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore mdr reporting criteria applicable to this event.510(k) number of the device considered 'similar' is p100022/s027.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to mfr site as follows: importer site contact and address: (b)(6).(b)(4).This follow up mdr is being updated as additional images/ image review has been received.The investigation of this additional information is still pending, a follow up mdr will be submitted to include the investigation conclusions.
|
| |
|
Event Description
|
|
This follow up is being submitted to update the investigation following additional information (receipt of images and image review on (b)(6) 2019).Brief description: reason for trackwise entry occlusion/stenosis in the study leg.On (b)(6) 2017 during the index procedure the patient received two zilver© ptx© stents.The study lesion was in the left proximal and distal sfa.The lesion status was de novo and there was no calcification or thrombus observed pre-procedure.The inflow tract was patent and there was one runoff vessel.The lesion length was 200 mm and the proximal rvd was 5.10 mm and distal rvd was 5 mm.The percentage diameter stenosis in study lesion was 3 %.The post-procedure imaging showed 80 % diameter stenosis left in the study lesion.This has been queried.On (b)(6) 2017, (80 days post-procedure), the patient was hospitalized for an occlusion of the right (non-study leg) femoral artery.A ilio-femoral bypass was performed.This was not related to device or procedure.On (b)(6) 2017, (184 days post-procedure), a stenosis of the right femoral artery and femoropopliteal bypass was revealed.This was treated with placement of a stent.On (b)(6) 2017, (194 days post-procedure), a follow-up visit revealed a study leg rutherford classification of 3.The study lesion was occluded.On (b)(6) 2017, (298 days post-procedure), an occlusion of the left sfa was revealed.Angiography revealed 85 % stenosis.This was treated with an endovascular procedure where a stent was placed.No device malfunction was noted but the event was thought to be definitely related to the device.The relationship to the procedure was unknown.No pre-existing condition caused this.On (b)(6) 2018, (368 days post-procedure), a follow-up visit revealed a study leg rutherford classification of 0.The study lesion was patent.
|
| |
|
Manufacturer Narrative
|
|
This specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore mdr reporting criteria applicable to this event.510(k) number of the device considered 'similar' is p100022/s027.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: (b)(4).Device evaluation: the zisv6-35-125-5.0-80-ptx device of lot number c1243651 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.Lab evaluation ¿ n/a.Document review: prior to distribution zisv6-35-125-5.0-80-ptx devices are subjected to 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 zisv6-35-125-5.0-80-ptx of lot number c1243651 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has previously occurred with the current lot number.There is no requirement to take action as restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu) and patient pre-existing conditions can cause and/or contribute to restenosis within the stented artery.In this case the event of restenosis is recurring within the same patient and is most likely the result of the patient¿s pre-existing conditions or medical history.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1243651.There is no evidence to suggest that the customer did not follow the instructions for use.However it should be noted that restenosis of the stented artery is listed as a known potential adverse event within 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 additional imaging combined with the originally provided imaging supports a pattern of sfa occlusion from atherosclerotic lesions proximal the study stents, recurrent significant inflow limitation from cfa stenosis and occlusion, and progressive untreated iliac atherosclerotic stenosis.Although moderate stenosis from nih in proximal end of the zisv6-35-125-5.0-80-ptx and the distal end of the zisv6-35-125-5.0-120-ptx is confirmed, the zisv6-35-125-5.0-80-ptx stenosis formed in response to an additional non-study stent and the zisv6-35-125-5.0-120-ptx stenosis was aggravated by inflow limitation.2.The zisv6-35-125-5.0-80-ptx nih was a secondary response to insufficient overlap with a third stent implanted just superior to the zisv6-35-125-5.0-80-ptx.Because a third larger diameter stent was implanted flush with the zisv6-35-125-5.0-80-ptx superior end rather than overlapped into the zisv6-35-125-5.0-80-ptx, the sfa at this location would have been irritated by the differing stent diameters, the ends of the stents, and unsupported bending and twisting.Apart from smooth as opposed to sharp stent ends, the lack of overlap essentially functioned as a stent fracture.This irritation would have provoked nih.3.The zisv6-35-125-5.0-120-ptx stenosis followed a major unreported upstream sfa event, a new 65% stenosis of the left cfa, and continued tobacco abuse.The additional imaging documents interventions after the complaint event, not before.These events follow at a pattern of occlusion beginning proximal the stents followed by short term, less than six months, angiographic follow-up.When the moderate zisv6-35-125-5.0-120-ptx stenosis from nih that generated the complaint was discovered, it was likely during short term follow up of the undocumented event.Because the second non-study stent was implanted only after failed atherectomy and angioplasty of a new proximal occlusion, the first non-study stent was likely that implanted for a similar lesion.Consequently, the complaint stenosis involving the zisv6-35-125-5.0-120-ptx was likely discovered incidental to a proximal occlusion/severe stenosis requiring stent placement.4.The recurrent zisv6-35-125-5.0-120-ptx stenosis, that is not the subject of a complaint, began one year after implantation, after atherectomy, and was downstream recurrent severe left cfa stenosis.Because the stent was already covered with intima, the stent could not have had a biologic effect on this restenosis.Because it was located at the adductor canal which alone is prone to stenosis, the stent could have contributed to restenosis on a mechanical basis.5.Recurrent right leg atherosclerotic stenosis and occlusion was indicative of severe atherosclerotic disease and consistent with the reported continued tobacco abuse.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing conditions.From the information provided it is known that the patient had a medical history of hypertension, hypercholesterolemia and is a current smoker.It is known from the imaging review that the occlusions formed as a result of recurrent significant inflow limitation from cfa (common femoral artery) stenosis and occlusion, and progressive untreated iliac atherosclerotic stenosis.Summary: complaint is confirmed as the failure was verified in the image(s).According to the initial reporter, an additional stent was placed as a result of this event.Complaints of this nature will continue to be monitored for potential emerging trends.
|
| |
|
Event Description
|
|
This follow up is being submitted to update the investigation following additional information (receipt of images and image review 21-may-19).Previously report was submitted based on the surgical intervention (re-intervention and additional stent placement) carried out due to the occurrence of restenosis after zilver ptx (zisv6-35-125-5.0-80-ptx) implantation.Patient history: the study lesion was in the left proximal and distal sfa.The lesion status was de novo and there was no calcification or thrombus observed pre-procedure.The inflow tract was patent and there was one runoff vessel.The lesion length was 200 mm and the proximal rvd was 5.10 mm and distal rvd was 5 mm.The percentage diameter stenosis in study lesion was 3 %.On (b)(6) 2017 during the index procedure the patient received two zilver© ptx© stents.The post-procedure imaging showed 80 % diameter stenosis left in the study lesion.This has been queried.On (b)(6) 2017 ¿ (b)(6) 2017 (298 days post-procedure), an occlusion of the left sfa was revealed.Angiography revealed 85 % stenosis.This was treated with an endovascular procedure where a stent was placed.No device malfunction was noted but the event was thought to be definitely related to the device.The relationship to the procedure was unknown.No pre-existing condition caused this.
|
| |
|
Search Alerts/Recalls
|
|
|
