Catalog Number UNKNOWN |
Device Problem
Obstruction of Flow (2423)
|
Patient Problem
Occlusion (1984)
|
Event Date 01/22/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Pma/510(k) #: unknown.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
|
|
Event Description
|
4 total prs related to this occlusion adverse event, opened to address all 4 stent in place at the time of the occlusion: 3001845648-2018-00522 = zisv6-35-125-5.0-80-ptx; 3001845648-2018-00520 = zisv6-35-125-5.0-120-ptx; unknown stent (assumed zisv6-ptx); 3001845648-2018-00522 = unknown stent (assumed zisv6-ptx).On (b)(6) 2018, the patient was hospitalized where an occlusion in the study lesion was discovered via an angiography.No treatment was done.This occlusion was considered probably related to the study device.On (b)(6) 2018, the patient was hospitalized due to the occlusion in the study lesion.A stent was placed in the study lesion and in the primitive iliac artery.
|
|
Manufacturer Narrative
|
Pma/510(k) # = unknown.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).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
|
|
Event Description
|
4 total prs related to this occlusion adverse event, opened to address all 4 stent in place at the time of the occlusion: 3001845648-2018-00522 = zisv6-35-125-5.0-80-ptx; 3001845648-2018-00520 = zisv6-35-125-5.0-120-ptx; 3001845648-2018-00521 = unknown stent (assumed zisv6-ptx); and 3001845648-2018-00522 = unknown stent (assumed zisv6-ptx).On(b)(6) 2018, the patient was hospitalized where an occlusion in the study lesion was discovered via an angiography.No treatment was done.This occlusion was considered probably related to the study device.On (b)(6) 2018, the patient was hospitalized due to the occlusion in the study lesion.A stent was placed in the study lesion and in the primitive iliac artery.
|
|
Manufacturer Narrative
|
Pma/510(k) # = unknown.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.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 of restenosis cause 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.
|
|
Event Description
|
4 total prs related to this occlusion adverse event, opened to address all 4 stent in place at the time of the occlusion: 3001845648-2018-00522 = zisv6-35-125-5.0-80-ptx.3001845648-2018-00520 = zisv6-35-125-5.0-120-ptx.3001845648-2018-00521 = unknown stent (assumed zisv6-ptx).3001845648-2018-00522 = unknown stent (assumed zisv6-ptx).On (b)(6) 2018 - (b)(6) 2018, the patient was hospitalized where an occlusion in the study lesion was discovered via an angiography.No treatment was done.This occlusion was considered probably related to the study device.On (b)(6) 2018 - (b)(6) 2018, the patient was hospitalized due to the occlusion in the study lesion.A stent was placed in the study lesion and in the primitive iliac artery.
|
|
Manufacturer Narrative
|
Pma/510(k)#: unknown.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).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
|
|
Event Description
|
4 total prs related to this occlusion adverse event, opened to address all 4 stent in place at the time of the occlusion: 3001845648-2018-00522; zisv6-35-125-5.0-80-ptx; 3001845648-2018-00520; zisv6-35-125-5.0-120-ptx; unknown stent; (assumed zisv6-ptx); 3001845648-2018-00522; unknown stent (assumed zisv6-ptx).On (b)(6) 2018, the patient was hospitalized where an occlusion in the study lesion was discovered via an angiography.No treatment was done.This occlusion was considered probably related to the study device.On (b)(6) 2018, the patient was hospitalized due to the occlusion in the study lesion.A stent was placed in the study lesion and in the primitive iliac artery.
|
|
Search Alerts/Recalls
|