COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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Catalog Number ZIV6-35-125-6.0-120-PTX |
Device Problem
Occlusion Within Device (1423)
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Patient Problems
Occlusion (1984); Stenosis (2263); Claudication (2550)
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Event Date 09/28/2016 |
Event Type
Injury
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Manufacturer Narrative
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Pma/510(k) # p100022/s001.The ziv6-35-125-6.0-120-ptx stent of lot number c776875 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.There is no imaging available to support this investigation.According to the information provided, thrombosis was confirmed at the lesion where the ptx device was placed.Intermittent claudication and worsen rutherford were seen on the patient and a stent was placed against the thrombosis.Available information indicated that the patient had history of tobacco abuse.It can be noted that smoking has been listed as potential risk factor for thrombosis.It is possible that the patient had some additional risk factors identified above and these could have caused or contributed to the reported event.However, no other patient pre-existing conditions were provided.Based on the above it is unlikely that the reported occurrence could have occurred due to zilver ptx malfunction.However, due to limited information and lack of imaging a definitive root cause cannot be determined.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.As per the packaging insert, arterial thrombosis is a known potential adverse event associated with placement of this device.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 the lot number c776875.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number.According to the information provided, a stent was placed against the thrombosis and the patient condition improved.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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Event Description
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(b)(6) 2012: ziv6-35-125-6.0-120-ptx was placed in the patient's right sfa.(b)(6) 2016: thrombosis at the lesion where ptx was placed was confirmed by ultrasound.Intermittent claudication and worsen rutherford were seen on the patient from two weeks ago gradually.(b)(6) 2016: stent was placed against thrombosis.The patient's condition was improved.
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Manufacturer Narrative
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(b)(4).Pma/510(k) # p100022/s001.The ziv6-35-125-6.0-120-ptx stent of lot number c776875 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.There is no imaging available to support this investigation.According to the information provided, restenosis was confirmed at the lesion where the ptx device was placed.Intermittent claudication and worsen rutherford were seen on the patient and a stent was placed against the restenosis.Available information indicated that the patient had history of tobacco abuse.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.It may be noted that surface of the zilver ptx stent is coated with the drug (paclitaxel) to help prevent subsequent restenosis of the artery.In addition worsened claudication was also observed on the patient.It can be noted that this symptom indicates progression of peripheral artery disease and can also be associated with the restenosis process.It can be therefore stated that it is unlikely that the reported restenosis could have occurred due to zilver ptx malfunction.However, due to limited information and lack of imaging a definitive root cause cannot be determined.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.As per the packaging insert, restenosis is a known potential adverse event associated with placement of this device.Worsened claudication is also a known potential adverse event associated with placement of this device.In addition worsened claudication was also observed on the patient.It can be noted that this symptom indicates progression of peripheral artery disease and can also be associated with the restenosis process.Worsened claudication is also a known potential adverse event associated with placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device.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 the lot number c776875.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number.According to the information provided, a stent was placed against restenosis and the patient condition improved.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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Event Description
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This follow up report is being submitted due to the receipt of amended information in relation to this event.The conclusion of this investigation has been updated.Initial report details: on (b)(6) 2012: ziv6-35-125-6.0-120-ptx was placed in the patient's right sfa.On (b)(6) 2016: thrombosis at the lesion where ptx was placed was confirmed by ultrasound.Intermittent claudication and worsen rutherford were seen on the patient from two weeks ago gradually.On (b)(6) 2016: stent was placed against thrombosis.The patient's condition was improved.Updated report details: on (b)(6) 2012: ziv6-35-125-6.0-120-ptx was placed in the patient's right sfa.On (b)(6) 2016: restenosis (100%) at the lesion where ptx was placed was confirmed by ultrasound.Intermittent claudication and worsen rutherford were seen on the patient from two weeks ago gradually.On (b)(6) 2016: stent was placed against restenosis (100%).The patient's condition was improved.
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