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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Catalog Number ZIV6-35-125-6.0-120-PTX
Device Problem Insufficient Information (3190)
Patient Problems Occlusion (1984); Surgical procedure, additional (2564)
Event Date 10/21/2013
Event Type  Injury  
Event Description
On (b)(6) 2012 a ziv6-35-125-6.0-120-ptx device was placed in the left sfa of the pt.On (b)(6) 2013: restenosis was confirmed.On (b)(6) 2013: pta was performed, and the pt had a favourable outcome.Note re-stenosis occurred at a later date with this pt and device.(b)(4).
 
Manufacturer Narrative
Pma/510(k)#: p100022 and s001.(b)(4).The ziv6-35-125-6.0-120-ptx stent of lot number c776874 was implanted in the pt therefore is not available for eval.With the info 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 (eg during pta and/or stenting).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.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 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 also another stent was additionally placed.The pt had a favourable outcome.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
 
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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. regulatory aff
61334440
MDR Report Key4309127
MDR Text Key5208568
Report Number3001845648-2014-00289
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
P100022
Number of Events Reported1
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 Received11/28/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/04/2014
Device Catalogue NumberZIV6-35-125-6.0-120-PTX
Device Lot NumberC776874
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/21/2013
Event Location Hospital
Date Manufacturer Received11/05/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age80 YR
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