Catalog Number UNKNOWN |
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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(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, 3001845648-2018-00515, 3001845648-2018-00516, 3001845648-2018-00518.
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Manufacturer Narrative
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510 (k) number: p100022/s014.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).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 (b)(4) (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).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.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).Reporting based on surgical intervention (re-intervention and additional stent placement) carried out due to the occurrence of restenosis after unknown stent (assumed zisv6-ptx) implantation.This mdr is related to mdr reports: 3001845648-2018-00044, 3001845648-2018-00045, 3001845648-2018-00519, 3001845648-2018-00514, 3001845648-2018-00515, 3001845648-2018-00516, and 3001845648-2018-00518.
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Manufacturer Narrative
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510 (k) number: p100022/s014.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).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)(4), cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington , indiana 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation: the unknown 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.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.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 -(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.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).Reporting based on surgical intervention (re-intervention and additional stent placement) carried out due to the occurrence of restenosis after unknown stent (assumed zisv6-ptx) implantation.This mdr is related to mdr reports; 3001845648-2018-00044, 3001845648-2018-00045, 3001845648-2018-00519, 3001845648-2018-00514, 3001845648-2018-00515, 3001845648-2018-00516, 3001845648-2018-00518.
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Manufacturer Narrative
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510 (k) number: p100022/s014.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).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)(4), cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington , indiana 47402-4195.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 - (b)(6) 2018, these were both treated with a stent placement and an angioplasty.This was considered probably related to the device.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).Reporting based on surgical intervention (re-intervention and additional stent placement) carried out due to the occurrence of restenosis after unknown stent (assumed zisv6-ptx) implantation.This mdr is related to mdr reports; 3001845648-2018-00044, 3001845648-2018-00045, 3001845648-2018-00519, 3001845648-2018-00514, 3001845648-2018-00515, 3001845648-2018-00516, 3001845648-2018-00518.
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Search Alerts/Recalls
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