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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING

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MEDTRONIC IRELAND ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Lot Number UNKNOWN
Device Problems Fracture; Activation, Positioning or Separation Problem
Event Date 08/30/2018
Event Type  Malfunction  
Manufacturer Narrative

Date of publication optical coherence tomography predictors for recurrent restenosis after paclitaxel-coated balloon angioplasty for drug-eluting stent restenosis. Doi: 10. 1253/circj. Cj-18-0464. If information is provided in the future, a supplemental report will be issued.

 
Event Description

548 drug-eluting stent (des) in-stent restenosis (isr) lesions were exclusively treated with pcb angioplasty for the first time between september 2008 and december 2016. Medtronic zotarolimus and resolute zotarolimus-eluting stents were among the des that exhibited restenosis. Lesions treated included the left main, lad, left circumflex and right. This study investigated the association between oct findings and mid-term angiographic outcomes. The main findings of the study were: the heterogeneous pattern was associated with recurrent restenosis at follow-up; smaller post-procedural mla, caused primarily by persistent stent under expansion, was also a main cause of recurrent restenosis; and previous stent fracture, heterogeneous pattern, and stent under expansion were independent risk factors for recurrent restenosis.

 
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Brand NameENDEAVOR RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway  
091708734
MDR Report Key8225859
Report Number9612164-2019-00104
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/08/2019 Patient Sequence Number: 1
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