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

Catalog Number RONYX30022X

Device Problems Difficult To Position (1467); Material Deformation (2976)

Patient Problems Intimal Dissection (1333); No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The physician intended to use three resolute onyx drug eluting stents to treat a lesion located in the ostium of the left anterior descending (lad) artery.The lesion was reported to be severely tortuous, severely calcified with 80% stenosis.It was reported that for ronyx27515x no issues were noted removing the device from the hoop/tray.For ronyx30015x and ronyx30022x no damage was noted to packaging.For the ronyx27515x, stent deformation occurred.For ronyx30015x and ronyx30022x, stent deformation occurred during positioning/advancement.No patient injury reported.

Manufacturer Narrative

Additional information: patient medical history: ex-smoker, previous ami in 2008, very deteriorated lvef, underwent myocardial revascularization surgery with 3 grafts: ita-lad, svg-om, svg-rca, occasionally presents with angina at rest.A stress test resulted positive for ischemia, and he was sent from his regional general hospital for cardiac catheterization.Coronary angiography: left coronary artery: diffuse disease from ostium, distal segment with 80% lesion due to eccentric plaque.Left anterior descending artery: chronic total occlusion from ostium, timi 0 distal flow.Circumflex artery: non dominant, large-caliber vessel, with 60% proximal lesion which extends to the proximal segment of om1, distal segment of the small-caliber, short circumflex, timi 3 distal flow.Large-caliber, long om1, 60% lesion in proximal segment.Timi 3 antegrade flow.Contrast medium visible moving to a small position in the venous graft which is occluded.Right coronary artery: dominant, large-caliber vessel, with significant diffuse disease from proximal segment; chronic total occlusion with timi 0 flow at the start of mid segment.Vessel distality visible via collateral circulation from the rca and other arteries (rentrop grade 2).Venous grafts: occluded from the proximal segment.Mammary graft: no significant angiographic lesions, with anastomosis in the distal mid segment of the lad.3.0 x 15 mm resolute onyx stent is moved from the lca into the proximal circumflex, and is deployed at 16 atm.An unsuccessful attempt to insert a 3.0 x 22 mm resolute onyx stent was made.Another shorter stent was then tried: the 2.75 x 15 mm resolute onyx , which became dislodged and stuck in the coronary artery, and has to be recovered with the guidewire crossing technique.The guide catheter is successfully retrieved, but it pulls out the previously implanted 3.0 x 15mm stent.Control angiography shows dissection at the level of the coronary artery to the circumflex, which extends to the distal om, with loss of flow and hemodynamic instability.Non-mdt 0.014" guidewires were inserted to the distal om, enabling a 2.5 x 15 mm resolute onyx stent to be inserted to the distal om, and deployed at 20 atm.Then another resolute onyx 2.75 x 30 mm was inserted and connected to the former, and deployed at 20 atm.Next, a resolute onyx 3.0 x 34 mm stent was inserted and connected to the previous one, and deployed at 20 atm, restoring timi 3 antegrade flow.Finally, a resolute onyx 3.5 x 12 mm stent was connected to the previous one, covering the entire length to the ostium of the coronary artery, and was deployed at 22 atm with angiographic success.Post-dilatations performed at all connecting points.Final result: timi 3 flow to distal om, with no dissection data.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Event summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 6-8th distal stent wraps with struts raised and bunched.Deformation was evident to the distal tip, with tip appearing torn.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, 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 Key: 6773048
• MDR Text Key: 82038508
• Report Number: 9612164-2017-01008
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2018
• Device Catalogue Number: RONYX30022X
• Device Lot Number: 0008394959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/08/2017
• Supplement Dates Manufacturer Received: 07/11/2017; 01/11/2018
• Supplement Dates FDA Received: 12/13/2017; 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2016
• 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: 54 YR
• Patient Weight: 75