MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number G24935

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Claudication (2550)

Event Date 06/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s001.The ziv6-35-125-6-100-ptx device of lot number c1096737 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.Images of the implanted device were provided.The investigation will be updated once the images have undergone a clinical review.From customer testimony, it is known that the patient had a history of coronary artery disease, hypertension, and hypercholesterolemia.The lesion morphology revealed a tasc (transatlantic inter-society consensus) i type b lesion and a tasc ii type a lesion with mild calcification and no thrombus.There was no previous intervention in the study lesion.There was no inflow tract stenosis greater than 50% and two patent runoff vessels.Baseline angiographic lesion measurements revealed a proximal reference vessel diameter (rvd) of 5.0 mm, a distal rvd of 6.0 mm, and 90% diameter stenosis.The lesion length was 40.0 mm.There is no evidence to suggest this event did not occur.Therefore, the customer complaint is confirmed based on customer testimony.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.From the information provided, it is known that the patient had risk factors for restenosis, including coronary artery disease, hypertension, and hypercholesterolemia.The patient exhibited a re-emergence of claudication, which could suggest a progression of the peripheral arterial disease in the proximal superficial femoral artery (sfa).However, as images of the device have not yet been evaluated, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.As per the product instruction for use, restenosis of the stented artery is listed under potential adverse effects.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.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1096737.According to the initial reporter, the patient experienced worsened claudication and rest pain in the study leg.A left common femoral artery to left below the knee popliteal bypass procedure was performed as a result of this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

(b)(6) ¿ worsened claudication/rest pain definitely related to the study product.On (b)(6) 2015, the patient received one 6 mm x 100 mm zilver ptx study stent in the left proximal sfa.On (b)(6) 2015, the patient underwent pre-dilatation of study lesion with one inflation of a 5.0 mm x 40 mm balloon at 10 seconds.One 6.0 mm x 100 mm (lot # c1096737) was placed in the left proximal sfa via contralateral access.The implanting physician noted that ease of device deployment was easy.No non-study stents were used to treat the study lesion.Post-stent dilatation was performed with two inflations of a 6.0 mm x 100 mm dilatation balloon for 52 seconds at 8 atm and one inflation for 30 seconds at 16 atm.At the conclusion of the case, no thrombus or dissection was noted by the site, and the entire length of the study stent was apposed to the vessel wall.There was no residual stenosis remaining in the study lesion and the proximal and distal rvd was 5.0 mm and 6.0 mm, respectively.The post-procedural abi was not performed for the study leg.On the same day, the patient was discharged from the hospital taking plavix and aspirin.Between (b)(6) 2017 (633 days post-procedure) and (b)(6) 2017 (796 days post-procedure), the patient experienced worsened claudication and rest pain in the study leg.On (b)(6) 2017 (796 days post-procedure), a left common femoral artery to left below the knee popliteal bypass procedure was performed.The physician determined that the event was definitely related to the study product and procedure (site queried).The patient¿s pre-existing peripheral vascular disease caused or contributed to this event.The investigator also determined that the device did malfunction or deteriorate in characteristics or performance, and this event could have led to death or serious deterioration in health had suitable intervention not occurred (site queried).

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Mfr site: (b)(4).Importer site establishment registration number: 3005580113.Pma/510(k) # p100022/s001.The ziv6-35-125-6-100-ptx device of lot number c1096737 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.From customer testimony, it is known that the patient had a history of coronary artery disease, hypertension, and hypercholesterolemia.The lesion morphology revealed a tasc (transatlantic inter-society consensus) i type b lesion and a tasc ii type a lesion with mild calcification and no thrombus.There was no previous intervention in the study lesion.There was no inflow tract stenosis greater than 50% and two patent runoff vessels.Baseline angiographic lesion measurements revealed a proximal reference vessel diameter (rvd) of 5.0 mm, a distal rvd of 6.0 mm, and 90% diameter stenosis.The lesion length was 40.0 mm.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: findings: implantation angiography is provided.A four month post implantation ultrasound and subsequent secondary intervention angiography are provided.Six and 24 month follow up ultrasounds and 12 month x-rays are provided along with the complaint report.The study lesion was a left sfa stenosis proximal to a pre-existing mid distal sfa (superficial femoral artery) stent.This stent had four markers on each end.It may have been a zilver stent although it also could represent another manufacture's stent with four markers such as an lnnova, complete se, or misago stent.A mild to moderate distal sfa stenosis at the inferior margin of the pre-existing stent, mild popliteal stenosis, and mild pre-existing in-stent stenosis were not treated.The study stent overlapped the pre-existing stent by one centimeter.Three vessel runoff to the ankle and posterior tibial artery runoff into the foot were demonstrated.Four months after study stent implantation, the study and non-study stents occluded from the mid proximal study stent, through the non-study stent, into the proximal popliteal artery (pa).Orbital atherectomy with a csi catheter was performed in the non-study stent.Afterward, irregular residual stenosis in the non-study stent and the proximal popliteal artery indicated, at the least, moderate neointimal hyperplasia had been initially present.This was also confirmed by balloon deformation during subsequent angioplasty of both the study and non-study stents.No deformation occurred in the study stent while neointimal hyperplasia prevented the balloon from completely expanding when it was inflated in the non-study stent.Viabahn covered stents were then implanted from within 1.5cm of the study stent proximal end, through the non-study stent, and through the proximal popliteal artery residual stenosis.The stents were patent two months later on the six month ultrasound.A 12 month x-ray was normal.The 24 month ultrasound demonstrated occlusion of the stented segment.Impression: study stent occlusion prior to four months was thrombotic and secondary to downstream stenosis of the pre-existing non-study stent and the proximal pa (peripheral artery).Because the viabahn stents effectively removed the study stent from the circulation, the second occlusion at 24 months was secondary to viabahn stent occlusion.Significant findings relative to the patient's anatomy were observed.Runoff into the foot was single vessel.Significant findings relative to the disease state were observed.Study stent occlusion was thrombotic and secondary to stenosis of the downstream non-study stent and popliteal artery.The second occlusive event was secondary to viabahn stent occlusion.Significant findings relative to the use of the device were observed.The study stent was placed inside and proximal to a stenosis at the proximal margin of a pre-existing non-study stent.Significant findings relative to the design or performance of the device were not observed.Cause of adverse events was not observed.The customer complaint is confirmed based on in the findings of the image review.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.The image review confirmed that the study stent was thrombotic prior to four months after implantation.Possible root causes for this occurrence could include the patient's anatomy and pre-existing conditions.It is known that the patient had a history of coronary artery disease, hypertension, and hypercholesterolemia.The image review also noted that patient had only one run off vessel to the foot.The image review found that the patient disease state and anatomy, the use of the device and the other implanted stents could have caused or contributed to this occurrence.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.As per the product instruction for use, thrombosis of the stented artery is listed under potential adverse effects.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.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1096737.According to the initial reporter, the patient experienced worsened claudication and rest pain in the study leg.A left common femoral artery to left below the knee popliteal bypass procedure was performed as a result of this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up mdr is being submitted due to the receipt and review of images relating to this event.Initial report details: (b)(6) ¿ worsened claudication/rest pain definitely related to the study product.On (b)(6) 2015, the patient received one 6 mm x 100 mm zilver ptx study stent in the left proximal sfa.On (b)(6) 2015, the patient underwent pre-dilatation of study lesion with one inflation of a 5.0 mm x 40 mm balloon at 10 seconds.One 6.0 mm x 100 mm (lot # c1096737) was placed in the left proximal sfa via contralateral access.The implanting physician noted that ease of device deployment was easy.No non-study stents were used to treat the study lesion.Post-stent dilatation was performed with two inflations of a 6.0 mm x 100 mm dilatation balloon for 52 seconds at 8 atm and one inflation for 30 seconds at 16 atm.At the conclusion of the case, no thrombus or dissection was noted by the site, and the entire length of the study stent was apposed to the vessel wall.There was no residual stenosis remaining in the study lesion and the proximal and distal rvd was 5.0 mm and 6.0 mm, respectively.The post-procedural abi was not performed for the study leg.On the same day, the patient was discharged from the hospital taking plavix and aspirin.Between (b)(6) 2017 (633 days post-procedure) and (b)(6) 2017 (796 days post-procedure), the patient experienced worsened claudication and rest pain in the study leg.On (b)(6) 2017 (796 days post-procedure), a left common femoral artery to left below the knee popliteal bypass procedure was performed.The physician determined that the event was definitely related to the study product and procedure (site queried).The patient¿s pre-existing peripheral vascular disease caused or contributed to this event.The investigator also determined that the device did malfunction or deteriorate in characteristics or performance, and this event could have led to death or serious deterioration in health had suitable intervention not occurred (site queried).

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6787609
• MDR Text Key: 82476869
• Report Number: 3001845648-2017-00322
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002249353
• UDI-Public: (01)10827002249353(17)160217(10)C1096737
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: G24935
• Device Catalogue Number: ZIV6-35-125-6-100-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 08/11/2017
• Supplement Dates FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• 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: 59 YR