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

Catalog Number RONYX30026UX

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Aneurysm (1708); Rupture (2208)

Event Date 04/20/2021

Event Type  Injury  

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. (b)(6) 2021 b3: date of publication. If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: CORONARY 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 Key: 13003208
• MDR Text Key: 285676673
• Report Number: 9612164-2021-04843
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature

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 Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: RONYX30026UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• 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