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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number ENSP40024X
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)
Event Date 08/31/2019
Event Type  Injury  
Manufacturer Narrative
Journal article: right coronary artery pseudoaneurysm after drug-eluting stent: dilemma solved on dual-source computed tomography authors: vineeta ojha, kartik ganga, mumun sinha, and arun sharma journal: ann thorac surg year: 2020 reference: doi. Org/10. 1016/j. Athoracsur. 2019. 07. 038. Date of event: date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted entitled ¿right coronary artery pseudoaneurysm after drug-eluting stent: dilemma solved on dual-source computed tomography" it was reported that a patient had two endeavor sprint rx zotarolimus-eluting stents implanted in the proximal (4 x 24mm) and distal (3. 5 x 1. 5mm) rca artery. Three years later the patient presented with intermittent fever for 2 months. A mass lesion involving the right ventricular outflow tract (rvot) was observed. Angiography revealed a giant peripherally thrombosed pseudoaneurysm arising from the proximal-most rca via a narrow neck. It was causing mass effect over the rvot. The stents were occluded. The distal rca was reformed from the lad. There were multiple nodular lesions in both lungs with tree in bud changes, suggestive of active infection. The study reported that giant coronary artery aneurysms are extremely rare. Causes can include delayed healing of endothelium, medial inflammation, and hypersensitivity reactions owing to antiproliferative agents from drug eluting stents in addition to the procedural trauma. It was indicated that the patient most likely had type iii pseudoaneurysm which is of infectious or mycotic ethology and could have developed because of denudation of the already-inflamed endothelium owing to bacteremia or superimposed infection. Management consists of optimal antibiotic cover and surgical excision of the sac with coronary artery bypass graft.
 
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Brand NameENDEAVOR SPRINT RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key10874834
MDR Text Key217353623
Report Number9612164-2020-04528
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P060033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberENSP40024X
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 Received11/24/2020
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

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