• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC IRELAND RESOLUTE ONYX RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Catalog Number UNK-CV-GWY-ENDRESX
Device Problems Activation, Positioning or SeparationProblem (2906); Migration (4003)
Patient Problems Injury (2348); Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Please note that this device (endeavor resolute) is not marketed in the united states; however, it is similar to the united states marketed product (resolute integrity). This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the endeavor resolute rx coronary drug-eluting stent. Survey results from an interventional cardiologist in practice 19 years. In the past 12 months, the physician has used the endeavor resolute stent 50 times. 5 of the smallest (2. 25 x 8 mm), 35 intermediate (2. 25 x 12 mm to 4. 00 x 34 mm) and 10 of the largest sizes (4. 00 x 38 mm) of these stents were used. The following complications adverse events/effects were encountered with use of the endeavor resolute product over the last 12 months: one coronary artery perforation related to the procedure but not directly to the device itself. Two pericarditis events related to the procedure but not directly to the device itself. The following device complaints were encountered when using the endeavor resolute product over the last 12 months: four incomplete stent apposition events, all related to the procedure but not directly to the device itself stent migration occurred in one case with clinical/patient impact where medical or surgical intervention was required. It was stated that the stent had to be captured from abdominal aorta which led to prolongation of the procedure. Incomplete stent expansion occurred in 3 cases, 2 of which had no impact on the procedure but the remaining 1 did have clinical/patient impact. It was stated that the resulting impact on the patient was the occurrence of acute thrombosis and further medical or surgical intervention was also required. It was reported that the device did not perform as expected in terms of reaching the target lesion in one case due to curvature and not related to the stent. It was also reported that the device did not perform as expected in terms of dilation of the target lesion in 2 events. It was stated that this was due to the vessel being heavily calcified and was not related to the stent.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESOLUTE ONYX 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 Key10545075
MDR Text Key207311529
Report Number9612164-2020-03483
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK-CV-GWY-ENDRESX
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 Received11/30/2020
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

Patient Treatment Data
Date Received: 09/17/2020 Patient Sequence Number: 1
-
-