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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; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

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COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Catalog Number ZIV6-35-125-6.0-120-PTX
Device Problem Occlusion Within Device (1423)
Patient Problems Occlusion (1984); Claudication (2550); Surgical procedure, additional (2564)
Event Date 10/27/2014
Event Type  Injury  
Event Description
On (b)(6) 2012 ziv6-35-125-6.0-120-ptx (lot #c778923) was placed at right popa (above the knee).On (b)(6) 2014 patient had shown worsening claudication.Angiography confirmed the occlusion at the lesion where the ptx was placed.The physician suspected thrombosis in the ptx and applied suctioning to the thrombosis, however, it was impossible.Then based on this, the physician though it was not thrombosis, and placed the smart stent (6cm x 15cm) inside of the ptx.On (b)(6) 2014 there have been no further adverse effects to the patient reported as occurring as a result of this incident.
 
Manufacturer Narrative
Pma/510(k)#: p100022 and s001.(b)(4).Incident requires fda mdr report based on the surgical intervention carried out as a result of the suspected occlusion of the zilver ptx stent.Although it cannot be confirmed if thrombosis was the cause of the worsened claudication following the additional procedure, the surgical intervention was still carried out under the suspicion of acute thrombosis.The zilver ptx device involved in this complaint was implanted in the patient therefore is not available for evaluation.With the information provided, a document based investigation was carried out.Although requested images relating to this event have not been received.It may be noted that re-stenosis 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 (or amplifies) to the restenosis process.Restenosis of the stented artery is a known potential adverse event associated with the placement of the device.The complaint is confirmed based on customer testimony.A review of the manufacturing records revealed no discrepancies related to this complaint issue.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Due to the lack of images no other comments can be provided at this time.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.Quality engineering assessed the complaint and the risk has been determined to be low.
 
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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, senior specialist
61334440
MDR Report Key4314842
MDR Text Key5246045
Report Number3001845648-2014-00268
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
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 10/29/2014
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 Date04/26/2014
Device Catalogue NumberZIV6-35-125-6.0-120-PTX
Device Lot NumberC778923
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/27/2014
Event Location Hospital
Initial Date Manufacturer Received 10/30/2014
Initial Date FDA Received11/25/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age86 YR
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