MAUDE Adverse Event Report: MEDTRONIC INC, - SWINNEA MEDTRONIC 2.0 MM BY 15MM RESOLUTE ONYX STENT; CORONARY DRUG-ELUTING STENT

Model Number REF # RONYX20015UX,

Device Problems Failure to Deliver (2338); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 03/28/2021

Event Type  Injury  

Event Description

Coronary intervention, a 2.0mm by 15mm resolute onyx stent was attempted to be deployed.The stent was not able to be delivered to the desired location, upon attempting to remove the stent undeployed the stent came off the stent balloon delivery system.The stent remained in the coronary artery undeployed and off of its delivery system.Staff attempted to resolve issue but later determined to send to operating room to have emergent open heart surgery.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC 2.0 MM BY 15MM RESOLUTE ONYX STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC INC, - SWINNEA
• MDR Report Key: 11608106
• MDR Text Key: 243827139
• Report Number: MW5100519
• Device Sequence Number: 1
• Product Code: NIQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: REF # RONYX20015UX,
• Device Lot Number: OF 0010436193 REF # RONYX
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 56 YR
• Patient Weight: 109