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

Catalog Number ZIV6-35-125-7.0-120-PTX

Device Problem Insufficient Information (3190)

Patient Problems Reocclusion (1985); Surgical procedure, additional (2564)

Event Date 09/24/2014

Event Type  Injury  

Event Description

On (b)(6) 2012 three zilver ptx stents were placed in the right sfa of the patient.On (b)(6) 2014 restenosis (50~90 percent) in the lesion where the stent was implanted was confirmed.Observed worsened ruthford classification.Another stent was placed.On (b)(6) 2014 the condition of the patient had recovered.No further adverse effects to the patient have been reported as occurring the restenotic lesions were not specified therefore a separate report will be submitted foe each suspect device.This report relates to a ziv6-35-125-7.0-120-ptx of lot number c777749.Reference also related mdr reports 3001845648-2014-00313 and 3001845648-2014-00314.

Manufacturer Narrative

(b)(4).The device involved in this complaint is as follows: ziv6-335-125-7.0-120-ptx of lot number c777749 containing the zilver ptx drug eluting stent.Reference also related mdr reports 3001845648-2014-00313 and 3001845648-2014-00314.The stent in question remains implanted in the patient and is therefore not available for evaluation.With the information provided, a document based investigation was carried out.Images relating to this event are not available to support this complaint investigation at this time.It may be noted that 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.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 for zilver ptx devices revealed no discrepancies which could have contributed to this complaint issue.Due to the lack of images for review and as the conditions of use cannot be replicated in a laboratory setting it is not possible to conclusively determine the root cause for this complaint at this time.The complainant is confirmed based on customer testimony.As per the information provided, the patient's condition recovered.The risk associated with this complaint has been assessed by quality engineering and determined to be low.Quality engineering will continue to monitor complaints of this nature for emerging trends.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, specialist ; 61334440
• MDR Report Key: 4337004
• MDR Text Key: 5140373
• Report Number: 3001845648-2014-00315
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2014
• Device Catalogue Number: ZIV6-35-125-7.0-120-PTX
• Device Lot Number: C777749
• Other Device ID Number: UDI#: 0110827002513539(17)1404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2012
• 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: 78 YR