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

Catalog Number ZIV6-35-125-6-80-PTX

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.The information received relating to this event is currently being investigated.A follow up mdr report will be submitted with the investigation conclusions.

Event Description

Protocol 12-004, pt.(b)(6), study stent fracture at 12 months.On (b)(6) 2015, the patient underwent pre-dilatation of the study lesion before one 6 mm x 80 mm zilver ptx v study stent (lot # c1001232) was placed via contralateral access.The implanting physician noted that ease of positioning and confirming device placement to be very easy, but ease of deployment was rated to be neither easy nor difficult.No non-study stents were used to treat the study lesion and post-stent dilatation was performed.At the conclusion of the case, no thrombus or dissection was noted by the site, the entire length of the study stent was apposed to the vessel wall, and there was no residual stenosis remaining in the study lesion.The proximal and distal rvd was 5.0 mm.The core lab interpretation of the final angiography measurements of the procedure angiography reveal a proximal rvd of 5.11 mm, a distal rvd of 4.48 mm, an mld of 3.3 mm, and the percent diameter residual stenosis in the study lesion was 35.42%.On (b)(6) 2014 (36 days post-procedure), the post-procedural clinical assessment was performed and revealed the right and left abi was 0.67 and 1.03, respectively.On (b)(6) 2015 (368 days post-procedure), the 12-month clinical follow-up and ultrasound were completed.The right and left abis each measured 0.55 and 0.97, respectively.The right rutherford classification was three and the leg left was zero (site queried regarding healing of left foot wound).Patency of the study lesion was assessed by ultrasound examination and revealed that it was 50-99% stenosed within.On (b)(6) 2015 (375 days post-procedure), the 12-month follow-up x-ray was performed.It revealed a type iii stent fracture occurring in the mid-portion of the study stent.Core lab analysis of the 12 month ultrasound and x-ray is not available at this time.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001.Ziv6-35-125-6-80-ptx of lot number c1001232 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 cook research inc.(cri) and the following comments were provided by the independent reviewer: ¿findings: 1.Implantation angiography and one year follow up ultrasound and abis are provided along with the complaint report.2.The lesion was a severe distal left superficial femoral artery (sfa) stenosis that improved to moderate with angioplasty and was further improved with a single zilver ptx stent implanted in the sfa¿s distal third but terminating above the adductor canal.The lesion was severely calcified.30% residual stenosis (3.7/5.25mm) was present in the distal stent where the lesion was most calcified.A 70% spiral left external iliac artery (eia) stenosis was not relieved.The left common femoral artery (cfa) was narrowed 40%.This was also not relieved.The left posterior tibial artery (pta) was patent into the foot.The left anterior tibial artery (ata) was occluded and reconstituted at the ankle by the peroneal artery.¿¿.4.No stent fracture was evident on ultrasound.5.The x-rays demonstrate slight medial shift of the stent 25mm from the proximal end.The shift was caused in part by a large densely calcified lateral sfa plaque and was present on implantation.Both the implantation imaging and the year follow up x-rays are of insufficient quality to resolved individual stent struts.Impression: 1.The increased distal stent psv suggests moderate, 50-80%, distal stent stenosis.Given the minor abi decrease and the triphasic waveforms the stenosis severity is more likely 50 than 80%.2.Significant inflow limitation at the left eia origin was not addressed.3.The stent shift may represent a fracture however it was in part the result of a large densely calcified lateral wall sfa plaque and was present at implantation.Image quality is insufficient to confirm a fracture much less grade one.Since the area in question is within the proximal stent, it is likely unrelated to the moderate distal in-stent stenosis.¿ information provided stated that the patient had pre-existing conditions including coronary artery disease, cardiac arrhythmia, congestive heart failure nyha class 1, hypertension, hypercholesterolemia and was a previous smoker.The patient enrolled in the study to treat the left distal superficial femoral artery.From the imaging review, no stent fracture was present on the ultrasound.The x-rays demonstrated a medial shift of the stent partially caused by a dense calcification of the lateral sfa.The stent shift may represent stent fracture.However, the image quality is too poor to confirm stent fracture, therefore the complaint is confirmed based on customer testimony.It may be noted that according to instruction for use, stent strut fracture 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 adverse effects were experienced by the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up report is being submitted due to the receipt and review of images relating to this event.Initial complaint description submitted as follows: protocol 12-004, pt.(b)(6), study stent fracture at 12 months.On (b)(6) 2015, the patient underwent pre-dilatation of the study lesion before one 6 mm x 80 mm zilverptx v study stent (lot # c1001232) was placed via contralateral access.The implanting physician noted that ease of positioning and confirming device placement to be very easy, but ease of deployment was rated to be neither easy nor difficult.No non-study stents were used to treat the study lesion and post-stent dilatation was performed.At the conclusion of the case, no thrombus or dissection was noted by the site, the entire length of the study stent was apposed to the vessel wall, and there was no residual stenosis remaining in the study lesion.The proximal and distal rvd was 5.0 mm.The core lab interpretation of the final angiography measurements of the procedure angiography reveal a proximal rvd of 5.11 mm, a distal rvd of 4.48 mm, an mld of 3.3 mm, and the percent diameter residual stenosis in the study lesion was 35.42%.On (b)(6) 2014 (36 days post-procedure), the post-procedural clinical assessment was performed and revealed the right and left abi was 0.67 and 1.03, respectively.On (b)(6) 2015 (368 days post-procedure), the 12-month clinical follow-up and ultrasound were completed.The right and left abis each measured 0.55 and 0.97, respectively.The right rutherford classification was three and the leg left was zero (site queried regarding healing of left foot wound).Patency of the study lesion was assessed by ultrasound examination and revealed that it was 50-99% stenosed within.On (b)(6) 2015 (375 days post-procedure), the 12-month follow-up x-ray was performed.It revealed a type iii stent fracture occurring in the mid-portion of the study stent.Core lab analysis of the 12 month ultrasound and x-ray is not available at this time.

Manufacturer Narrative

Pma/510(k)#: p100022 and s001 ziv6-35-125-6-80-ptx of lot number c1001232 was implanted in the patient and is therefore not available for evaluation.With the information provided a document based investigation was carried out.Information provided stated that the patient had pre-existing conditions including coronary artery disease, cardiac arrhythmia, congestive heart failure nyha class 1, hypertension, hypercholesterolemia and was a previous smoker.Patient enrolled in study to treat the left distal superficial femoral artery.The complaint is confirmed based on customer testimony.It may be noted that according to instruction for use, stent strut fracture 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 adverse effects were experienced by the patient.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

Follow up report being submitted with investigation conclusions.Initial complaint description submitted as follows: protocol 12-004, pt.(b)(6), study stent fracture at 12 months.On (b)(6) 2015, the patient underwent pre-dilatation of the study lesion before one 6 mm x 80 mm zilver ptx v study stent (lot # c1001232) was placed via contralateral access.The implanting physician noted that ease of positioning and confirming device placement to be very easy, but ease of deployment was rated to be neither easy nor difficult.No non-study stents were used to treat the study lesion and post-stent dilatation was performed.At the conclusion of the case, no thrombus or dissection was noted by the site, the entire length of the study stent was apposed to the vessel wall, and there was no residual stenosis remaining in the study lesion.The proximal and distal rvd was 5.0 mm.The core lab interpretation of the final angiography measurements of the procedure angiography reveal a proximal rvd of 5.11 mm, a distal rvd of 4.48 mm, an mld of 3.3 mm, and the percent diameter residual stenosis in the study lesion was 35.42%.On (b)(6) 2014 (36 days post-procedure), the post-procedural clinical assessment was performed and revealed the right and left abi was 0.67 and 1.03, respectively.On (b)(6) 2015 (368 days post-procedure), the 12-month clinical follow-up and ultrasound were completed.The right and left abis each measured 0.55 and 0.97, respectively.The right rutherford classification was three and the leg left was zero (site queried regarding healing of left foot wound).Patency of the study lesion was assessed by ultrasound examination and revealed that it was 50-99% stenosed within.On (b)(6) 2015 (375 days post-procedure), the 12-month follow-up x-ray was performed.It revealed a type iii stent fracture occurring in the mid-portion of the study stent.Core lab analysis of the 12 month ultrasound and x-ray is not available at this time.

• 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: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5076812
• MDR Text Key: 25775502
• Report Number: 3001845648-2015-00176
• Device Sequence Number: 1
• Product Code: NIU
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-6-80-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: 08/14/2015
• Event Location: Hospital
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 57 YR