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

Catalog Number ZIV6-35-125-7.0-100-PTX

Device Problems Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problems Thrombosis (2100); Surgical procedure, additional (2564)

Event Date 05/13/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 three zilver ptx stents (ziv6-35-125-6.0-100-ptx/c963737 x 1, ziv6-35-125-7.0-100-ptx/c985991 x 1 and ziv6-35-125-7.0-100-ptx/c985944 x 1) were placed in the right sfa to treat cto by contralateral approach.The user was used to the ptx placement, so the procedure was completed with no problem.On (b)(6) 2015 thrombosis was confirmed.Then, thrombolysis as an emergent evt was performed.The pt recovered.On (b)(6) 2015 follow-up angiography confirmed that there was no problem.Urokinase was effective.As per the above description of event received, three devices are involved in this incident.This report addresses the investigation of the ziv6-35-125-7.0-100-ptx device of lot #c985944.Two additional reports will be submitted in relation to the other devices reported-report reference numbers: 3001845648-2015-00125 and 3001845648-2015-00126.

Manufacturer Narrative

(b)(4).The xziv6-35-125-7.0-100-ptx stent of lot number c985944 was implanted in the pt therefore is not available for evaluation.With the info provided a document based investigation was carried out.Procedural images were requested to support the complaint investigation.It has been confirmed that images are available and will be provided later.Once received, image review will be conducted and investigation will be updated accordingly.Additional info has been provided to support the complaint investigation.From the pt pre-existing conditions, it is known that the pt had known potential risk factors for thrombosis such as hypertension, uncontrolled diabetes, hyperlipidemia and smoking.In addition, lesion factors, such as total occlusion prior to stent placement (cto) and long target vessel length, were identified and these could have also contributed to the reported event.The following comments were provided by the physician: "the risk of thrombosis was low due to good run-off.I used the devices as usual.The stents expanded well and there was no calcification observed in the patient.Intima has abnormally been grown in the proximal side of the occluded site and the lesion was very hard." based on the additional info and physician's comments, pt's pre-existing conditions and progressing peripheral artery disease most likely caused/contributed to the reported event.It can be therefore concluded that it is unlikely that thrombosis occurred due to zilver ptx malfunction and was associated with the stent placement.However, since no imaging was available at the time of complaint investigation, a definitive root cause of this event cannot be determined and no other comments can be made.As no imaging wa available, the complaint is confirmed based on customer testimony.It may be noted that arterial thrombosis, stent thrombosis are known potential adverse events associated with the placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.According to info provided, thrombolysis was performed and the pt recovered.Quality engineering will continue to monitor complaints of this nature for potential emerging tends.

Manufacturer Narrative

Pma/510k#: p100022 and s001.(b)(4).Common name: niu stent, superficial femoral artery, drug-eluting.Product code: niu.The ziv6-35-125-7.0-100-ptx stent of lot number c985944 was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Images were provided to support the complaint investigation.These were reviewed through med institute and the following comments were provided by the independent reviewer: findings: the following were reviewed: video from the implantation procedure on (b)(6) 2015 includes angiography and ivus.Video from re­ intervention (b)(6) 2015 includes angiography, ivus, and optical coherence tomography (oct).Video from thrombolysis follow-up (b)(6) 2015 includes angiography and ivus.A moderate to severe above knee right popliteal artery stenosis was improved to moderate with angioplasty.Runoff to the mid-calf through small posterior tibial and peroneal arteries was demonstrated.The anterior tibial artery occluded soon after its origin.The three zilver stents were placed with appropriate overlap and no significant residual stenosis.Mild stenosis, less than 30%, was present in the proximal most zilver ptx just superior its overlap with the mid zilver ptx stent.One month later the stents thrombosed from just inside the proximal stent to the distal stent edge.On ivus the lumen was filled with generally hyperechoic material with flaps and interstices consistent with thrombus but also areas of complete lumen filling indistinguishable by hyperechoic material that could represent thrombus or intimal hyperplasia.Oct images demonstrated a "cheese grater" appearance consistent with thrombus.Antegrade flow was restored after thrombolysis with residual mild to moderate luminal narrowing from residual hyperechoic material consistent with clot morphologically on both ivus and angiography.Ivus demonstrated one area of mild, less than 30%, external stent compression not evident angiographically.The anterior tibial artery occlusion and patent peroneal and posterior tibial arteries to mid-calf were again demonstrated.No stent fracture or migration was imaged.Post thrombolysis stented segments free of thrombus demonstrated no endothelialization on ivus.Impression: in areas completely free of thrombus, the stented surface demonstrated no endothelialization.This and the very short interval between implantation support thrombotic occlusion as the sole etiology.The outflow was limited by an above knee popliteal artery stenosis and limited outflow.Multiple risk factors for thrombosis including long stented length, tobacco abuse, moderate inflow and outflow limitation, and moderate runoff limitation were present.The occlusion appeared thrombotic on angiography and ivus except possibly on two images where the submitter seems to suggest that fibrous neointimal hyperplasia was present possibly corresponding to the complaint report statement from the operator that the intima grew into the proximal side of the occluded site and was very hard.However thrombus and plaque cannot be reliably distinguished by ivus.Additionally, the ivus appearance did not persist after thrombolysis the stents extended into the distal sfa and were at risk of transient kinking with knee flexion.Based on the images provided, the customer complaint was confirmed as follow up imaging revealed stent thrombosis.Additional information has been provided to support the complaint investigation.From the patient pre-existing conditions, it is known that the patient had known potential risk factors for thrombosis such as hypertension, uncontrolled diabetes, hyperlipidemia and smoking.In addition, lesion factors, such as total occlusion prior to stent placement (cto) and long target vessel length, were identified and these could have also contributed to the reported event.The following comments were provided by the physician: ¿the risk of thrombosis was low due to good run-off.I used the devices as usual.The stents expanded well and there was no calcification observed in the patient.Intima has abnormally been grown in the proximal side of the occluded site and the lesion was very hard.¿ based on the image review, additional information and physician¿s comments, patient¿s pre-existing conditions and progressing peripheral artery disease most likely caused / contributed to the reported event.In addition multiple risk factors for thrombosis were present, from the image review, including long stented length, tobacco abuse, moderate inflow and outflow limitation and moderate runoff limitation.It can be therefore concluded that it is unlikely that thrombosis occurred due to zilver ptx malfunction.It may be noted that arterial thrombosis, stent thrombosis are known potential adverse events associated with the placement of this device.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.According to information provided, thrombolysis was performed and the patient recovered.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

On (b)(6) 2015, three ptx stents, ziv6-35-125-6.0-100-ptx/ c963737 x 1 + ziv6-35-125-7.0-100-ptx/ c985991 x 1 + ziv6-35-125-7.0-100-ptx/ c985944 x 1, were placed in the right sfa to treat cto by contralateral approach.The user was used to the ptx placement, so the procedure was completed with no problem.On (b)(6) 2015, thrombosis was confirmed.Then, thrombolysis as an emergent evt was performed.The patient recovered.On (b)(6) 2015, follow-up angiography confirmed that there was no problem.Urokinase was effective.As per the above description of event received, three devices are involved in this incident.This report addresses the investigation of the ziv6-35-125-7.0-100-ptx device of lot# c985944.Two additional reports will be submitted in relation to the other devices reported- report reference numbers: 3001845648-2015-00125 and 3001845648-2015-00126.

• 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 ; o'halloran road; national technology park; limerick ; EI ; 061334440
• MDR Report Key: 4867696
• MDR Text Key: 6261845
• Report Number: 3001845648-2015-00127
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2015,09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2015
• Device Catalogue Number: ZIV6-35-125-7.0-100-PTX
• Device Lot Number: C985944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2015
• Event Location: Hospital
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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