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

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

Device Problem Occlusion Within Device (1423)

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

Event Date 10/08/2014

Event Type  Injury  

Event Description

Date: (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 pt.Date: (b)(6) 2014: restenosis was confirmed.Reference previously submitted mdr reports 3001845648-2014-00302, 3001845648-2014-00303 and 3001845648-2014-00304.Date: (b)(6) 2014 occlusion was confirmed.Date: (b)(6) 2014: pta was performed, and the pt had a favourable outcome.As the occluded stent cannot be confirmed a separate report will be submitted for each suspect device.Reference also related mdr reports 3001845648-2014-00305 and 3001845648-2014-00306.

Manufacturer Narrative

(b)(4).This investigation addresses 1x ziv6-35-125-6.0-120-ptx of lot c777750.Reference also related mdr reports 3001845648-2014-00305 and 3001845648-2014-00306.Ziv6-35-125-7.0-120-ptx stent of lot number c777750 was implanted in the pt therefore is not available for eval.With the info provided a document based investigation was carried out.Additional info has been requested in order to determine whether the reported event relates to an occlusion due to thrombosis or occlusion due to restenosis.However, no other info has been received to date.From the available info it is known that the pt had a previous history of restenosis where pta was performed.Pta is a procedure for dilating blood vessels in the treatment of peripheral artery disease and it is likely that the reported occlusion was also related to restenosis.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.It is very unlikely that occlusion due to a restenosis could have occurred due to zilver ptx malfunction; however a definitive root cause of this event cannot be determined.Although requested no imaging or other info 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 mfg records revealed no discrepancies that could have contributed to this complaint.According to info provided, pta was performed and the pt had a favorable outcome.Qual 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: sinead quaid, sr specialist ; 61334440
• MDR Report Key: 4332208
• MDR Text Key: 5218365
• Report Number: 3001845648-2014-00307
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• 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: 12/03/2014
• 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: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C777750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/08/2014
• Event Location: Hospital
• Date Manufacturer Received: 11/06/2014
• 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: 66 YR