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

Catalog Number ZIV6-35-125-6.0-120-PTX

Device Problem Occlusion Within Device (1423)

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

Event Date 04/07/2014

Event Type  Injury  

Event Description

(b)(6) 2012 two ziv6-35-125-6.0-120-ptx devices and a ziv6-35-125-7.0-120-ptx device were placed in the right sfa of the patient.(b)(6) 2014: restenosis was confirmed.(b)(6) 2014: pta was performed, and the patient had a favourable outcome.As the restenosed stent cannot be confirmed a separate report will be submitted for each zilver ptx device.Reference related reports 3001845648-2014-00302 and 3001845648-2014-00304.Note occlusion of the above zilver ptx stents occurred again at a separate and later date of event.Reference reports 3001845648-2014-00305, 3001845648-2014-00306 and 3001845648-2014-00307.The patient had a favourable outcome.

Manufacturer Narrative

(b)(4).This investigation addresses 1x ziv6-35-125-6.0-120-ptx of lot c778920.Reference related reports 3001845648-2014-00302 and 3001845648-2014-00304.The ziv6-35-125-7.0-120-ptx stent of lot number c778920 was implanted in the patient, therefore is not available for evaluation.With the information provided a document based investigation was carried out.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 setting).Vessel injury provokes an inflammatory response that leads to (or amplifies) the restenosis process.It is very unlikely that restenosis could have occurred due to zilver ptx malfunction; however, a definitive root cause of this stent restenosis cannot be determined.Although requested no imaging or other information was available to support the complaint investigation, therefore no other comments can be made.As no imaging was available, the complaint is confirmed based on customer testimony.It may be noted that 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 revealed no discrepancies that could have contributed to this complaint.According to information provided, pta was performed and the patient had a favourable outcome.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: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING.
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid ; 61334440
• MDR Report Key: 4317523
• MDR Text Key: 5206601
• Report Number: 3001845648-2014-00303
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C778920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2014
• Event Location: Hospital
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2012
• 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