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

Device Problem Activation, Positioning or SeparationProblem (2906)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2020

Event Type  Injury  

Event Description

An article was submitted for review titled: percutaneous coronary intervention for delayed coronary obstruction due to endothelialization of self-expandable transcatheter heart valve: a case report. The case report is of a patient who underwent transcatheter aortic valve implantation with a self-expandable valve, without any complications. The patient was admitted to hospital eight months later with effort angina. Electrocardiography showed new st-segment depression in v5¿6 leads. The tte showed hypokinesis in the anterior segment and eoa of 1. 56 cm2. Laboratory test results were within normal value, except for high-sensitivity troponin i levels. Adenosine stress myocardial perfusion scintigraphy performed to identify ischaemic area showed myocardial ischaemia in the anterior region. Computed tomography revealed that the thv frame was covered with a low-density mass between the leaflet and stj, which occluded the left coronary sinus (lcs). The transoesophageal echocardiogram (toe) showed a doppler signal flowing from the ncs to the lcs was detected through a gap between aortic wall and the thv. The roundabout route was also confirmed using the corresponding ct image. A coronary guidewire was inserted through the roundabout route from the ncs into the lcs. Using a dual-lumen microcatheter, another coronary guidewire was advanced into the distal left anterior descending artery. Following balloon angioplasty, a 4. 00 mm x 15 mm resolute onyx drug eluting stent was deployed into the roundabout route. The intravascular ultrasound (ivus) showed under-expansion of the stent, despite post-dilatation with a 4. 0-mm non-compliant balloon. Another 4. 00 mm x 15 mm resolute onyx drug eluting stent was implanted into the first stent, which improved stent expansion. Final coronary angiography showed a roundabout route and improved flow to the left coronary artery. After the procedure, the patient¿s symptom improved. At the 4-month follow-up, the patient had remained asymptomatic.

Manufacturer Narrative

Journal article: percutaneous coronary intervention for delayed coronary obstruction due to endothelialization of self-expandable transcatheter heart valve: a case report. Year: 2020 ref: doi:10. 1093/ehjcr/ytaa288 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13511908
• MDR Text Key: 289184845
• Report Number: 9612164-2022-00571
• 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,Study,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• 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: 02/11/2022 Patient Sequence Number: 1