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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT
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COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT Back to Search Results
Catalog Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Thrombosis (2100)
Event Date 11/22/2020
Event Type  Injury  
Manufacturer Narrative
Niu stent, superficial femoral artery, drug-eluting.(b)(4).
 
Event Description
Mu¨ller-hu¨lsbeck 2020 ¿two-year efficacy and safety results from the imperial randomized study of the eluvia polymer-coated drug-eluting stent and the zilver ptx polymer-free drug-coated stent¿ to report additional endpoints, including 2-year primary patency, patient outcomes, and safety results, as well as the initial assessment of hypoechogenic halo from the imperial randomized controlled trial (rct).Imperial rct is a prospective, randomized (2:1), multicenter study of patients with symptomatic femoropopliteal artery lesions (length 30¿140 mm, rutherford category 2¿4) treated with the eluvia paclitaxel eluting nitinol stent or the zilver ptx paclitaxel-coated stent.Two-year follow-up included patency, safety, and mortality assessments and core laboratory- reviewed b-mode ultrasound imaging to screen for hypoechogenic halo in the stented segment, and assess blood flow.This complaint captures stent thrombosis - 4.1% (as per table 2 -6/145).
 
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Brand Name
ZILVER PTX 35 DRUG-ELUTING STENT
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key11111808
MDR Text Key225050790
Report Number3005580113-2021-00002
Device Sequence Number1
Product Code NIU
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 12/30/2020,01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date12/21/2020
Event Location Hospital
Date Report to Manufacturer12/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
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