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

Catalog Number ZIV6-35-125-7.0-120-PTX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Thrombosis (2100); Surgical procedure, additional (2564)

Event Date 12/05/2013

Event Type  Injury  

Event Description

On (b)(6) 2012 two ziv6-35-125-7.0-120-ptx devices were placed in a long cto lesion in the sfa of a male patient with cli.On (b)(6) 2013 restenosis due to the thrombosis was confirmed.Worsen rutherford, tissue loss, rest pain, ulcer and coldness were observed with the patient.Thrombosis extended in both of the placed stents.Poba and aspiration of blood clots were conducted against it on the same day and the blood flow improved.Since the patient has cli, he visits the hospital every week.The condition of the patient after the intervention performed on (b)(6) 2013 is good.No further adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

(b)(4).P100022 and s001.(b)(4).The zilver ptx device involved in this complaint was implanted in the patient therefore is not available for evaluation.With the information provided, a document based investigation was carried out.The below list indicates potential risk factors that can generally contribute to the thrombosis event: patient factors: history of coagulopathy/prior thrombosis (e.G., dvt), diabetes, especially if poorly controlled, cancer/chemotherapy, advanced age, obesity, hyperlipidemia, hypertension, smoking.Lesion factors: long lesion, small vessel diameter, severe calcification, lesion totally occluded prior to stent placement, placement for in stent restenosis.Procedure factors: residual inflow, outflow, or in-segment stenosis or dissection, poor run off (i.E., beyond trifurcation).Medication factors: inadequate procedural heparinization, inadequate loading dose of antiplatelet (ticlopidine or clopidogrel), inadequate dapt prescribed, non-responder to the apt, or non-compliant with prescribe regimen.Images relating to this event were received and reviewed as follows: findings: 83 angiographic runs from the secondary intervention 1215/2013 are provided; 29 demonstrate left sfa intervention while the remaining 54 demonstrate efforts to restore blood flow to the distal left anterior and posterior arteries and pedal arch after embolic occlusion.The initial angiography was performed through a left common femoral antegrade sheath.The sheath was placed in a severely diseased left cfa artery above a left sfa 40mm zilver stent, likely a bms, since it was excluded as a complaint device.The proximal zilver stent remained patent from outflow provided by a small sfa muscular branch.Later angiography would demonstrate diffuse severe left sfa inflow limitation.The distal left external iliac artery was narrowed to 3.6mm, the mid cfa to 3.5mm, the distal cfa to 3.8mm, and the proximal sfa zilver stent to 3.3mm.Severe multiple atherosclerotic stenoses involving the left profunda femoral artery demonstrate that the patient's atherosclerotic process was aggressive.Typically the profunda is relatively spared even in the presence of severe disease elsewhere.The zilver ptx stents had been placed in the mid through distal sfa.There was no fracture or compression.Overlap was adequate.An unstented sfa segment was between the zilver ptx stents and the sfa origin stent.Aspiration embolectomy and angioplasty followed an injection that demonstrated mainly thrombotic occlusion of the zilver ptx stents and an unstented sfa.A residual 50% stenosis mainly representing recoiled neointimal hyperplasia was present in the mid proximal zilver ptx stent elsewhere,the zilver ptx stents were lined with neointimal hyperplasia causing mild stenosis.A combination of dissection and residual thrombus in unstented sfa segment prompted stenting with a smart stent.This extended through the proximal sfa stent across the unstented segment and into the proximal zilver stent.This eliminated the residual thrombus and dissection related stenosis.No imaging prior to sfa embolectomy of the calf runoff of was performed.However the posterior tibial artery was likely patent into the foot while the anterior tibial artery was at least severely stenotic in the mid-calf.Extensive interventions through both arteries overlapping in the pedal arch consisted of at least long segment angioplasty and mechanical clot disruption.Whether thrombolytics were injected cannot be determined.The final imaging showed restored left posterior tibial artery patency to the distal foot and anterior tibial patency to the distal calf.Impression: primarily thrombotic sfa occlusion beginning in the unstented proximal sfa segment just superior the zilver ptx stents was likely caused by a combination of unstented segment stenosis, very poor inflow, poor outflow, and aggressive atherosclerotic disease.The zilver ptx stent neointimal hyperplasia contributed but was mild other than a focal area of moderate stenosis in the proximal zilver ptx stent.Given these challenges, the 16 month primary patency is remarkable considering historical sfa stent patency rates.According to thrombosis questionnaire completed for this complaint the patient had known potential risk factors for thrombosis such as uncontrol!ed diabetes and hemodialysis.In addition, the patient was (b)(6), the lesion was long and 90% occluded prior to stent placement, the vessel diameter was 6mm and severely calcified and the patient had cu.These are all factors that could have contributed to this event.The questionnaire also revealed that it was unknown if the patient was heparinised, however antiplatelet therapy was administrated before and after the procedure.The complaint is confirmed based on customer testimony.As per the above feedback it can be stated that it is unlikely that thrombosis occurred due to zilver ptx malfunction.According to the independent image review, primarily thrombotic sfa occlusion beginning in the unstented proximal sfa segment just superior the zilver ptx stents was likely caused by a combination of unstented segment stenosis, very poor inflow, poor outflow and aggressive atherosclerotic disease.However, a definitive root cause of this thrombosis cannot be determined.A review of the manufacturing records revealed no discrepancies related to this complaint issue.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Arterial thrombosis is a known potential adverse event associated with the placement of this device.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr. specialist ; 61334440
• MDR Report Key: 4346515
• MDR Text Key: 5201873
• Report Number: 3001845648-2014-00327
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P100022/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2014
• Device Catalogue Number: ZIV6-35-125-7.0-120-PTX
• Device Lot Number: C777750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2013
• Event Location: Hospital
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR