• 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 CORONARY DRUG-ELUTING STENT

  • 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 CORONARY DRUG-ELUTING STENT Back to Search Results
Catalog Number RONYX30030UX
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Aneurysm (1708); Rupture (2208)
Event Date 04/20/2021
Event Type  Injury  
Manufacturer Narrative
Title: a giant pseudoaneurysm due to coronary rupture caused by stent separation following percutaneous coronary intervention year: 2021. Reference: doi: 10. 1016/j. Jcin. 2021. 04. 040. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A literature article titled; a giant pseudoaneurysm due to coronary rupture caused by stent separation following percutaneous coronary intervention was submitted for review. A patient with was hospitalized for congestive heart failure with severe stenosis and calcification in the mid right coronary artery. High-pressure expansion using a noncompliant balloon was repeatedly performed for the severely calcified lesion. After balloon dilatation, two resolute onyx drug eluting stents were deployed overlapping. The overlapping stent struts were located at the site of hinge motion. Finally, percutaneous intervention was completed, establishing grade 3 flow. Three weeks after intervention the patient became unstable. Coronary angiography revealed a giant coronary artery aneurysm at the stent overlap site in the right coronary artery, and stent separation. Computed tomography coronary angiography confirmed the findings; the coronary artery aneurysm diameter was 25 x 25 mm. Urgent coronary artery bypass grafting and aneurysmal repair were performed. The operative findings showed a complete coronary rupture and pseudoaneurysm with migration of part of the stents into the pseudoaneurysm. There was no evidence of stent fracture at the observation site. The proposed mechanism of pseudoaneurysm formation was that the overlapping stents moved, separating because of the motion of the vessel with oscillation and vertical association with the cardiac cycle at the hinge site. Finally, the edges of the separated stents induced vessel wall injury and coronary rupture, leading to a pseudoaneurysm. In the present case, coronary artery aneurysm was caused by stent separation, a rarer mechanism than stent fracture. From this rare case, it was conclude that when overlapping stents are deployed, risk reduction is possible by avoiding an overlap at the hinge site and extending the stent overlap part.
 
Manufacturer Narrative
Title: a giant pseudoaneurysm due to coronary rupture caused by stent separation following percutaneous coronary intervention year: 2021. Reference: doi: 10. 1016/j. Jcin. 2021. 04. 040. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A literature article titled; a giant pseudoaneurysm due to coronary rupture caused by stent separation following percutaneous coronary intervention was submitted for review. A patient with was hospitalized for congestive heart failure with severe stenosis and calcification in the mid right coronary artery. High-pressure expansion using a noncompliant balloon was repeatedly performed for the severely calcified lesion. After balloon dilatation, two resolute onyx drug eluting stents were deployed overlapping. The overlapping stent struts were located at the site of hinge motion. Finally, percutaneous intervention was completed, establishing grade 3 flow. Three weeks after intervention the patient became unstable. Coronary angiography revealed a giant coronary artery aneurysm at the stent overlap site in the right coronary artery, and stent separation. Computed tomography coronary angiography confirmed the findings; the coronary artery aneurysm diameter was 25 x 25 mm. Urgent coronary artery bypass grafting and aneurysmal repair were performed. The operative findings showed a complete coronary rupture and pseudoaneurysm with migration of part of the stents into the pseudoaneurysm. There was no evidence of stent fracture at the observation site. The proposed mechanism of pseudoaneurysm formation was that the overlapping stents moved, separating because of the motion of the vessel with oscillation and vertical association with the cardiac cycle at the hinge site. Finally, the edges of the separated stents induced vessel wall injury and coronary rupture, leading to a pseudoaneurysm. In the present case, coronary artery aneurysm was caused by stent separation, a rarer mechanism than stent fracture. From this rare case, it was conclude that when overlapping stents are deployed, risk reduction is possible by avoiding an overlap at the hinge site and extending the stent overlap part.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESOLUTE ONYX RX
Type of DeviceCORONARY DRUG-ELUTING STENT
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 Key13003221
MDR Text Key286115214
Report Number9612164-2021-04844
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRONYX30030UX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2022
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: 12/14/2021 Patient Sequence Number: 1
-
-