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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Occlusion (1984); Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

The physician tried to cross a long chronic total occlusion and went subintimal in the distal sfa.The physician was not able to cross the distal sfa.As a result, he crossed with spectranetics laser.After crossing, he successfully deployed several overlapping zilver ptx stents.A few months later, the pt came back with pseudo-aneurysms.The physician had to realign the zilver ptx stents with a covered stent.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.This report addresses the first device reported.An add'l separate report will be submitted in relation to the second device reported- report reference number: 3001845648-2015-00071.

Manufacturer Narrative

The zilver ptx stent involved in this complaint remains implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out three still images of an angiography monitor were provided to support the complaint investigation.Images were analysed by the independent reviewer: the image demonstrates a mid and inferior sfa segment and pseudoaneurysms are present at the superior and inferior ends of the shifted stent segment the pseudoaneurysms developed at the most inferior stent superior end and the most inferior 60mm stent superior end.Although it is possible that the drug coating injured a very thin remnant of vessel wall initially containing the contrast column, the pseudoaneurysms are much more likely related to an extravascular or near extravascular recanalization than the drug coating.First, the drug should have diffusely involved the sfa rather than occurring in just two locations.Rupture in this location demonstrates the vessel was very fragile.The pseudoaneurysms developed at the ends of a rightward shift in the stent's course.The shift corresponds to intramural spiraling with intraluminal exit and reentry at each end.It is at the beginning and end of an intramural recanalization that the vessel is often weakened most severely- first by probing and then by the acute course change of the stents.The more inferior pseudoaneurysm did involve the distal sfa; the segment acknowledged at risk of being extravascular as it required laser recanalization.Upon review of the only prior known post zilver ptx sfa pseudoaneurysm case, review of coronary artery aneurysm formation post stenting, and review of non-human drug coated stent studies, the most likely cause of aneurysm formation is a near or extravascular stent location rather than the zilver ptx anti-proliferative properties.The ptx was clearly extravascular in the only preceding sfa pseudoaneurysm complaint.The zilver ptx lacks polymer associated with a vigorous inflammatory potential.Failed past attempts to exclude aneurysms with uncovered stents demonstrate that neointimal hyperplasia could not prevent pseudoaneurysm development drug coated coronary stents are no more prone to coronary aneurysm formation than bare metal coronary stents.In this case, the recanalization channel was extra or near extravascular and steered back into the lumen by chance or laser re-entry.Consequently, the pseudoaneurysms would have likely developed whether the zilver was coated or not.Based on the images provided, the customer complaint can be confirmed as pseudoaneurysms were demonstrated at the superior and inferior ends of the shifted stent segment.According to the independent reviewer, the most likely cause of aneurysm formation is a near extravascular or extravascular stent location rather than the zilver ptx anti-proliferative properties.Pseudoaneurysms would have likely developed whether the zilver stent was coated or not based on the above it can be stated that it is unlikely that this event could have occurred due to zilver ptx stent malfunction.As per instruction for use, pseudoaneurysm formation is listed as a 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 could not be conducted as no lot number was provided.The patient did not experience any adverse effects due to this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr ra specialist ; 61334440
• MDR Report Key: 4687286
• MDR Text Key: 21245346
• Report Number: 3001845648-2015-00072
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention
• Patient Age: 85 YR