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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; Migration or Expulsion of Device
Event Date 06/01/2008
Event Type  Injury  
Manufacturer Narrative

A completely fractured zotarolimus-eluting stent in an aortocoronary saphenous vein bypass graft. Doi 10. 1002/ccd. 24312. Still procedural images show- svg-d-om bypass graft after deployment of a endeavor zotarolimus-eluting stent for in-stent restenosis. Images also show evidence of a highly mobile svg-d-om bypass with a complete fracture of a zotarolimus-eluting stent at the ostium and svg-d-om bypass with restored timi 3 flow after percutaneous intervention that included removal of the proximal section of the fractured stent from the bypass. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Patient had 3 non medtronic stents implanted to the ostium of the svg-d-om bypass (b)(6) 2004. On (b)(6) 2007 the patient returned with unstable angina that required deployment of a non medtronic stent to treat the ostium of the svg-d-om bypass for the first episode of in-stent restenosis. On (b)(6) 2008 the patient was admitted with unstable angina and diagnosed with a second episode of ostial svg-d-om bypass graft in-stent restenosis. During revasc procedure, an endeavor zes was implanted to treat restenosis. The stent was deployed at 16atm for 25 seconds and post-dilated at 21 atm for 30 seconds with 0% post-procedure stenosis. 85 days later ((b)(6) 2018) post implant of endeavor rx drug eluting stent, the patient was re-admitted with chest pain and a non stemi. Total occlusion was noted of the previously treated svg-d-om bypass with total occlusion and evidence of proximal fracture in a highly dynamic portion of the vessel. 2 sprinter balloons were used to dilate the area of instent restenosis distal to the stent fracture and the proximal stent fracture area itself. The guidewire, balloon and guide catheter were removed together restoring of thrombolysis in myocardial infarction (timi flow 3) in the bypass graft. The proximal section of the fractured stent was reported to have dislodged at the femoral artery sheath level. Vascular surgery evaluation located the dislodged fragment in a branch of the right femoral profundis artery. It was decided to leave the stent fragment in the femoral profundis branch. The patient recovered without any issue and discharged from hospital 2 days later.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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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 Key8586288
Report Number9612164-2019-01602
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2019
Is This An Adverse Event Report? Yes
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 Received04/10/2019
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: 05/07/2019 Patient Sequence Number: 1
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