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

Model Number G24894

Device Problem Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of(b)(4).The investigation into this event is still being carried out.A follow up report will be submitted within the next 30 days with the investigation conclusions.

Event Description

(b)(6) ¿ occlusion/restenosis probably related to study product.On (b)(6) 2014, the patient received one 7 mm x 60 mm zilver ptx study stent in the right proximal sfa.On (b)(6) 2014, the patient underwent pre-dilatation of study lesion with one inflation of a 6.0 mm x 40 mm balloon and a 6.0 mm x 20 mm balloon (inflation duration and atm information is not available).One 7.0 mm x 60 mm (lot # c1000612) was placed in the right 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 one inflation of a 6.0 mm x 40 mm dilatation balloon (inflation duration and atm information is not available).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 rvds were 6.0 mm.The post-procedural abi was not performed for the study leg.On the same day, the patient was discharged from the hospital taking plavix.On (b)(6) 2016 (785 days post-procedure), the patient experienced an occlusion/restenosis of the study lesion requiring intervention.The patient continued to take plavix.On (b)(6)2016 (786 days post-procedure), a secondary intervention was performed and treatment included a balloon angioplasty.The physician determined that the occlusion/restenosis of the study lesion was probably related to the study product and the patient¿s pre-existing peripheral vascular disease caused or contributed to this event.The device did not malfunction or deteriorate in characteristics or performance.No other device related adverse events have been reported.

Manufacturer Narrative

(b)(4).Importer site establishment registration number: (b)(4).This follow up report is being submitted to cancel the initial report sent in relation to this event.Initial reporting was based on the surgical intervention carried out as a result of the occurrence of occlusion/restenosis within the lesion where a zilver ptx stent was indwelling.The mdr reporting decision has been re-assessed as no longer meeting the fda mdr reporting requirements as the image review confirmed that the surgical intervention carried out was not as a result of the restenosis within the lesion where a zilver ptx stent was indwelling but was in the pre-existing non-study stent.No restenosis was observed in the study device in the image review.Investigation details: the (b)(4) stent of lot number c1000612 was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.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: finding: implantation angiography, one year follow up x-rays and ultrasound, and two year follow up ultrasound is provided along with the complaint report.No additional information was provided with the additional complaint except that the secondary intervention was performed one day after the 9/21/16 ultrasound rather than on the same day.The target lesion was a focal, heavily calcified 70% (1.1mm minimum lumen diameter/4.1mm distal rvd(reference vessel diameter)) mid right sfa (superficial femoral artery) stenosis, superimposed on diffused, heavily calcified plaque causing mild to moderate stenosis.Inflow was limited by a distal right external iliac artery (eia) stenosis and mild to moderate proximal sfa stenosis.The right eia stenosis was either an in-stent stenosis or wall calcification which simulated the appearance of a stent.The outflow was limited by multiple above knee popliteal artery (pa) heavily calcified stenosis.Because they were imaged partially enface, they were likely more severe than suggested on the anterior/posterior projection.The severity was likely between 50-75%.Outflow was also limited by a remotely implanted distal sfa self-expanding stent.This stent contained neointimal hyperplasia causing 50% stenosis in the mid and distal stent.Runoff was single vessel to the foot via the anterior tibial artery.The posterior tibial and peroneal arteries occluded soon after the tibial peroneal trunk.The target lesion was treated with angioplasty and stenting.The implanted stent length based on the calibration tape was 45mm and the stent diameter 4mm.The calibration tape was on the table.This causes magnification artifact ranging from 10-20%.Consequently, the actual implanted stent length was 50 to 54mm and stent diameter 4.5-5mm.The stent was mildly constrained, less than 25%, at its distal end by heavily calcified plaque.The eia stenosis was relieved with stent implantation.The neointimal hyperplasia involving the pre-existing stent was not treated.The one year follow up ultrasound demonstrated a moderate stenosis of the proximal right common femoral artery (cfa) based on a doubling of psv (peak systolic velocity) without a color flow jet.This correlated with a mild to moderate untreated proximal right cfa stenosis on angiography at implantation; otherwise, no other stenosis was imaged.The study stent was normal on explicitly labeled images.Imaging of the more distal non-study stent was not included.One year follow up x-rays consisted of fluoroscopic clips.This limited resolution but suggested that the stents were imaged with and without knee flexion.Although the knee was not included on the imaging, two of the four clips demonstrated at least mild knee flexion during a steeply oblique projection.Sfa tortuosity mildly increased but no stent kinking or external compression was observed.The zilver stent length changed between images; however, this was likely secondary to foreshortening artifact rather than vessel stretching.At two years, ultrasound demonstrates a severe stenosis based on a 4.5 times increase in proximal versus distal psv, involving stent labeled as in the distal sfa.Additional complaint number (b)(4) with same complaint "occlusion/restenosis probably relate to study product.Impression: although a distal sfa in-stent severe stenosis at two years is confirmed, the labeling states that the stenosis occurred in a distal sfa stent.Because of the pre-existing distal sfa non-study stent neointimal hyperplasia at implantation and the clearly labeled normal study stent at one year, the imaged stenosis was more likely in the non-study stent.The additional complaint adds no significant information to challenge the observation that the stenosis just prior to the secondary intervention was in the pre-existing non-study stent and not the study stent.The study stent was implanted in 6-10mm of compression.The study stent was implanted on a background of extensive diffuse disease.Although the moderate inflow limitation was addressed, the outflow limitations were not.Significant findings relative to the patient's anatomy were observed.A pre-existing non study stent in the distal sfa was narrowed 50% in two locations by neo-intimal hyperplasia.Runoff was single vessel to the foot via the anterior tibial artery.Significant findings relative to the disease state were observed.The inflow and outflow were diffusely affected by heavily calcified plaque.Significant findings relative to the use of the device were observed.Although a significant inflow limiting, right eia stenosis was relieved, outflow limitation in the pre-existing stent and the above knee pa were not.The stent was implanted in mild compression.Significant findings relative to the design or performance of the device were not observed.Cause of adverse events was not observed.A complaint file has been opened for the stent compression.Refer to report ref#3001845648-2016-00335 for details of that investigation.Additional comments were received from the clinical reviewer: "based on how the provided imaging was labeled, the stenosis was not in the study stent but in the nonstudy stent.Implanting a stent in compression was most likely secondary to the operator putting forward pressure on the system during deployment.Sometimes the stent can extract itself but the shortening in those situations is usually much greater." it may be noted that the patient had the following pre-existing conditions at the time of the procedure: this (b)(6) year-old male presented at the time of enrollment with a history of coronary artery disease, myocardial infarction, hypertension, carotid disease, type ii diabetes mellitus, and smoking (past).The lesion morphology revealed a tasc (trans-atlantic inter-society classification) i type b lesion and a tasc ii type a lesion with severe calcification and no thrombus.There was no previous intervention in the study lesion.There was inflow tract stenosis greater than 50% successfully treated before the placement procedure.There was one patent runoff vessel.Baseline angiographic lesion measurements revealed a proximal and distal reference vessel diameter (rvd) of 6.0 mm and 80% diameter stenosis.The lesion length was 40.0 mm.The customer complaint is not confirmed, as no restenosis was observed in the study device in the image review.Restenosis is a common adverse event of endovascular procedures and can be caused by injury to the vessel (e.G.During pta and/or stenting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.It may be noted that surface of the zilver ptx stent is coated with the drug (paclitaxel) to help prevent subsequent restenosis of the artery.It can be therefore stated that it is very unlikely that the reported restenosis could have occurred due to zilver ptx malfunction; however as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause of this event cannot be determined.It may be noted that as per the instructions for use, restenosis of the stented artery is a known potential adverse event 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.No other device related adverse events have been reported.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

This follow up report is being submitted to cancel the initial report sent in relation to this event.Initial reporting was based on the surgical intervention carried out as a result of the occurrence of occlusion/restenosis within the lesion where a zilver ptx stent was indwelling.On receipt of the image review for this complaint on 19-jul-2017 it was confirmed that no restenosis was observed in the study device."the additional complaint adds no significant to challenge the observation that the stenosis just prior to the secondary intervention was in the pre-existing non-study stent and not the study stent.¿ clarification in relation to this statement was requested from the reviewer and the following comment was provided: "based on how the provided imaging was labeled, the stenosis was not in the study stent but in the non-study stent" the mdr reporting decision has been re-assessed as no longer meeting the fda mdr reporting requirements as the image review confirmed that the surgical intervention carried out was not as a result of the restenosis within the lesion where a zilver ptx stent was indwelling but was in the pre-existing non-study stent.No restenosis was observed in the study device in the image review.Initial report details: (b)(6) - occlusion/restenosis probably related to study product.On (b)(6) 2014, the patient received one 7 mm x 60 mm zilver ptx study stent in the right proximal sfa.On (b)(6) 2014, the patient underwent pre-dilatation of study lesion with one inflation of a 6.0 mm x 40 mm balloon and a 6.0 mm x 20 mm balloon (inflation duration and atm information is not available).One 7.0 mm x 60 mm (lot # c1000612) was placed in the right 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 one inflation of a 6.0 mm x 40 mm dilatation balloon (inflation duration and atm information is not available).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 rvds were 6.0 mm.The post-procedural abi was not performed for the study leg.On the same day, the patient was discharged from the hospital taking plavix.On (b)(6) 2016 (785 days post-procedure), the patient experienced an occlusion/restenosis of the study lesion requiring intervention.The patient continued to take plavix.On (b)(6) 2016 (786 days post-procedure), a secondary intervention was performed and treatment included a balloon angioplasty.The physician determined that the occlusion/restenosis of the study lesion was probably related to the study product and the patient¿s pre-existing peripheral vascular disease caused or contributed to this event.The device did not malfunction or deteriorate in characteristics or performance.No other device related adverse events have been reported.Related to report ref#3001845648-2016-00304.

• 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: 6679987
• MDR Text Key: 78788001
• Report Number: 3001845648-2017-00254
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002248943
• UDI-Public: (01)10827002248943(17)150121(10)C1000612
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G24894
• Device Catalogue Number: ZIV6-35-125-7-60-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/02/2017
• Event Location: Hospital
• Date Manufacturer Received: 06/08/2017
• Date Device Manufactured: 05/13/2014
• 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
• Patient Age: 71 YR