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

Catalog Number ZIV6-35-125-8.0-60-PTX

Device Problems Kinked (1339); Activation, Positioning or Separation Problem (2906)

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

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k): p100022 and s001.This event is currently still under investigation.A follow up report will be submitted within 30 days with the investigation conclusions.

Event Description

The zilver ptx stent foreshortened and kinked on delivery.The device was implanted in the patient as planned.Post stent placement angioplasty was performed.This event is currently still under investigation.A follow up report will be submitted within 30 days with the investigation conclusions.

Manufacturer Narrative

Pma/510(k): p100022 and s001.The ziv6-35-125-8.0-60-ptx stent of lot number c1042812 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 and the following comments were provided by the independent reviewer: ¿findings: still images from post deployment angiography and angioplasty are provided along with the complaint report.The imaging only includes the right common iliac artery (civ), the distal aorta and the proximal right external iliac artery (eia) the 8x60mm zilver ptx stent was deployed in a moderately tortuous right cia stenosed on each end but dilated to 10x12mm in the mid segment.The external iliac artery through which the deployment sheath was advanced was at least moderately if not severely tortuous.The right cia and imaged portion of the eia were moderately to severely calcified.The first 10mm of the stent deployed normally within the proximal stenosis.The remaining stent deployed in a folded z shaped configuration and failed to reach the distal cia stenosis.The folded stent measured only 50mm on centerline reflecting at least 10mm shortening from stent spiraling and compression.The 8x40mm zilver stent (cancelled report 3001845648-2016-00010) was implanted in the folded stent distal end to span the distal right cia stenosis.This stent deployed normally.With an angioplasty balloon inflated through the stents, stent spiraling through the folded segment was evident.Impression: the stent deployed in a partially folded but also spiraled within a dilated and tortuous right cia segment.Inadvertent delivery system twist after fixation of the stent¿s first 10mm would have shortened the mid-stent and pulled it out of the delivery sheath because the mid-stent was floating in the dilated segment.Delivery system twist could have either been stored in the sheath as it traversed the calcified tortuous iliac arteries or occurred at the handle.Significant findings relative to the patient¿s anatomy were observed.The iliac arteries were tortuous and moderately to severely calcified.The mid right cia was dilated beyond the implanted stent diameter.Significant findings relative to the disease state were not observed.Significant findings relative to the use of the device were observed.The stent was deployed in a folded and spiral configuration.Significant findings relative to the design or performance of the device were not observed.¿ the customer complaint can be confirmed as the stent deployed in a partially folded and spiraled configuration.According to the imaging review, the stent was advanced through moderately, if not severely, calcified tortuous anatomy.The first 10mm of the stent deployed normally but the remaining stent deployed in a folded z shape configuration.The stent was shortened by at least 10mm due to spiraling and compression.The spiraling of the stent could have occurred in the sheath as it was advanced though the tortuous anatomy, or occurred at the handle.Significant findings relative to the patient¿s anatomy were observed.The iliac arteries were tortuous and severely calcified.No findings relative to the design or performance of the device were observed.Significant findings relative to the use of the device were also observed.The stent was deployed in a folded and spiraled configuration.It can be noted that as per instructions for use, it states ¿do not rotate any part of the system during deployment¿.From additional information received, it is known that the device was flushed through both flushing ports and a 0.035¿¿ wire guide was used during the procedure.Advancement of the delivery system was described as reasonably easy.The stent was deployed smoothly and without difficulty, however, according to the rep, ¿it just created the bend during deployment without any indication it was going to do this¿.The physician stated that the stent was shorter in length (foreshortened) rather than compressed and confirmed that difficulty was only encountered with the proximal stent.Based on the above, it is unlikely that this event occurred due to zilver ptx malfunction.The most likely cause of this occurrence was the patient¿s tortuous anatomy or the use of the 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 did not reveal any discrepancies that could have contributed to this issue.According to information provided, post stent placement angioplasty was performed.No adverse effects to the patient were reported due to 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 and due to the conclusion on the investigation into this event.Initial event description: 'stent foreshortened and kinked on delivery'.

Manufacturer Narrative

Pma/510(k): p100022 and s001.This event is currently still under investigation and images are currently pending review by an independent reviewer.A follow up report will be submitted within 30 days with the investigation conclusions.

Event Description

This event is currently still under investigation and images are currently pending review by an independent reviewer.A follow up report will be submitted within 30 days with the investigation conclusions.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL 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: 5353333
• MDR Text Key: 35355610
• Report Number: 3001845648-2016-00008
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-8.0-60-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: 10/08/2015
• Event Location: Hospital
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 80