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

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.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 13003221
• MDR Text Key: 286115214
• Report Number: 9612164-2021-04844
• 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,Consumer
• Reporter Occupation: Physician
• 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: Health Professional
• Device Catalogue Number: RONYX30030UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female