Catalog Number ZISV6-35-125-5.0-120-PTX |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
Occlusion (1984)
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Event Date 05/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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510 (k) number: n/a.(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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On (b)(6) 2018, the patient was hospitalized where an occlusion was discovered in the study lesion and in the non-study leg.On (b)(6) 2018, these were both treated with a stent placement and an angioplasty.This was considered probably related to the device.This mdr is related to mdr reports; 3001845648-2018-00044; 3001845648-2018-00045; 3001845648-2018-00519; 3001845648-2018-00514; 3001845648-2018-00516; 3001845648-2018-00517; 3001845648-2018-00518.
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Manufacturer Narrative
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510 (k) number: p100022/s014.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 510(k) number provided is of the device considered "similar".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).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: (b)(4).Device evaluation: there are four files related to this complaint.For details of the other investigations please refer to complaint files: (b)(4).The zisv6-35-125-5.0-120-ptx device of lot number: c1287834 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.Document review: prior to distribution zisv6-35-125-5.0-120-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 zisv6-35-125-5.0-80-ptx of lot number: c1287834 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 the stent of lot number: c1287834 had been implanted in the patient prior to this event.This was a new event within the same patient and as a result of a number of stents being previously implanted in the patient; it could not be confirmed as to which stent the occlusion occurred within and so each stent implanted in the patient at the time could have been the occluded stent.Each stent will be investigated individually.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number: c1287834.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: a number of attempts have been made to obtain imaging for review.However, at the time of the investigation, this was not available.The investigation will be updated when the images are received by cook ireland.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause for restenosis could be attributed to the patient¿s pre-existing conditions.From the information provided, it is known that the patient has a history of hypertension, hypercholesterolemia and is a current smoker.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.According to the initial reporter, an additional stent was placed as a result of 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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On (b)(6) 2018, the patient was hospitalized where an occlusion was discovered in the study lesion and in the non-study leg.On (b)(6) 2018, these were both treated with a stent placement and an angioplasty.This was considered probably related to the device.
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Manufacturer Narrative
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510 (k) number: p100022/s014.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 510(k) number provided is of the device considered "similar".Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (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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On (b)(6) 2018 - (b)(6) 2018, the patient was hospitalized where an occlusion was discovered in the study lesion and in the non-study leg.On (b)(6) 2018, these were both treated with a stent placement and an angioplasty.This was considered probably related to the device.This mdr is related to mdr reports; 3001845648-2018-00044, 3001845648-2018-00045, 3001845648-2018-00519, 3001845648-2018-00514, 3001845648-2018-00516, 3001845648-2018-00517, 3001845648-2018-00518.
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Event Description
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On (b)(6) 2018 - (b)(6) 2018, the patient was hospitalized where an occlusion was discovered in the study lesion and in the non-study leg.On (b)(6) 2018 - (b)(6) 2018, these were both treated with a stent placement and an angioplasty.This was considered probably related to the device.
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Manufacturer Narrative
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510 (k) number: p100022/s014 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 510(k) number provided is of the device considered "similar" 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).Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
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Search Alerts/Recalls
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