MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZISV6-35-125-5.0-120-PTX

Device Problem Obstruction of Flow (2423)

Patient Problems Occlusion (1984); No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # = p100022/s014.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Restenosis and intervention in (b)(6) 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 ¿ (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.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.The patient required angioplasty following restenosis.This complaint report does not meet the requirements of an adverse reaction/device defect report as per 21 cfr part 814.82 (a)(9).

Manufacturer Narrative

Pma/510(k) # = p100022/s014.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 zisv6-35-125-5.0-120-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.This file was opened on receipt of the imaging review: ¿diagnostic angiography 5/29/2018 demonstrated recurrent stenosis at the zisv6-35-125-5.0-120-ptx's distal end.However, rather than moderate, this time the stenosis was severe.Severe left cfa stenosis had also recurred.These recurrent stenoses were angioplastied (b)(4)2018.¿.Lab evaluation ¿ n/a.Document review: prior to distribution zisv6-35-125-5.0-120-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 zisv6-35-125-5.0-120-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 restenosis of the stented artery is listed as a known potential adverse event within the instructions for use 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 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: 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 possible that the patient¿s pre-existing conditions caused and/or contributed to this event.From the information provided it is known that the site indicated that multiple previous hospitalisations for the lower limbs may have caused and/or contributed to this event.It is known from the information provided that the stent did not malfunction or deteriorate in characteristic or performance.Summary: the complaint is confirmed as the failure was verified in the image(s).According to the initial reporter, the patient underwent angioplasty as a result of this event.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This report is being submitted based on related to zisv6-35-125-5.0-120-ptx.Diagnostic angiography (b)(6) 2018 demonstrated recurrent stenosis at the zisv6-35-125-5.0-120-ptx's distal end.However, rather than moderate, this time the stenosis was severe.Severe left cfa stenosis had also recurred.These recurrent stenoses were angioplastied (b)(6) 2018.¿.Patient history: 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.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8707805
• MDR Text Key: 148297497
• Report Number: 3001845648-2019-00265
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352770
• UDI-Public: (01)10827002352770(17)181003(10)C1287834
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2018
• Device Catalogue Number: ZISV6-35-125-5.0-120-PTX
• Device Lot Number: C1287834
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 66