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

Catalog Number ZIV6-35-80-6.0-120-PTX

Device Problem Restricted Flow rate (1248)

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

Event Date 07/22/2014

Event Type  Injury  

Event Description

This report is being submitted in relation to a zilver ptx device with restricted bloodflow through the stent due to restenosis.Knowledge of this complaint issue arose from an image review related to another complaint under investigation (zilver flex device reported for a stent fracture).No knowledge of this complaint event prior to the receipt of the image review.Image review noted procedural angiogram images showed an occluded right sfa.A zilver ptx device (this report) and a zilver flex device (separate complaint investigation) were placed in the right sfa on the (b)(6) 2012.On (b)(6) 2014 (2 years later), the patient had returned to the angiosuite for a new intervention of the right leg after sub-acute symptoms.The secondary intervention images showed a diminished blood flow within the zilver ptx stent.The zilver ptx stent was ballooned with a wanda balloon and blood flow was restored.No further adverse effects to the patient have been reported as occuring as a result of the restricted blood flow through the zilver ptx stent.

Manufacturer Narrative

The involved zilver ptx stent (zivs-35 80-6.0-120-ptx, lot# unknown) was implanted in the patient therefore is not available for evaluation.With the information provided a document based investigation was carried out.Angiogram images were provided to support the complaint investigation and the following impression from the image review was provided: "native vessels stenosis is consistent with atherosclerotic plaque.Ln-stent stenosis is consistent with intimal hyperplasia although atherosclerotic plaque could be present as well.Thrombus was not present or it would have likely embolized distally upon angioplasty.Diffuse severe stenosis developed over the two years not only in the stented segments but in the popliteal and the profunda femoral arteries.The stent fractures may have contributed locally, causing occlusion rather than stenosis.However it is unlikely, given the severe disease progression in the profunda, that the occlusions were a significant factor elsewhere.If the bare metal zilver stent fractures had never occurred (separate complaint investigation for zilver flex device), the patient would still have presented with severe recurrent disease although perhaps slightly later.The most common reason for this is persistent tobacco abuse.At least moderate inflow and moderate to severe outflow limitation likely aggravated the restenosis to a minor degree.Given the persistent severe popliteal stenosis and the diffuse severe disease process, limited patency is expected." from the image review, the customer complaint can be confirmed as restricted blood flow due to restenosis was observed within the zilver ptx stent.Stenosis was developed over the two years after initial stenting procedure not only in the stented segment but also in popliteal and profunda arteries.Stent fracture of the other zilver flex stent (separate investigation) implanted could have contributed to occlusion, however according to the image review, if the zilver flex fractures had never occurred, the patient would still have presented with a severe recurrent disease.Based on the above it can be stated that it is very unlikely that restenosis could have occurred due to zilver ptx malfunction.Image review indicates that in-stent stenosis is consistent with intimal hyperplasia although atherosclerotic plaque could be present as well.Therefore, recurring disease (related to patient's condition/tobacco abuse) is the most likely cause of the occlusion which resulted in diminished blood flow.However, a definitive cause of this event cannot be determined.As per instruction for use, restenosis of the stented artery is noted as a 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.The manufacturing records for the zilver ptx and zilver ptx drug eluting stent could not be reviewed as the specific lot number was not provided.The zilver ptx stent was ballooned and blood flow was restored, however according to independent reviewer, limited patency is expected due to severe popliteal stenosis and the diffuse severe disease process.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tracy o'sullivan, unk ; 61334440
• MDR Report Key: 4106204
• MDR Text Key: 4714843
• Report Number: 3001845648-2014-00170
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P100022/S001
• 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: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-80-6.0-120-PTX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/22/2014
• Event Location: Hospital
• Date Manufacturer Received: 08/15/2014
• 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): Required Intervention