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

Model Number RONYX27518UX

Device Problems Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Two resolute onyx coronary drug eluting stents were implanted to treat a non-tortuous lesion in the mid right coronary artery (rca). The devices were inspected with no issues noted. The mid-distal rca was pre-dilated with a semi compliant balloon. The devices did not pass through a previously deployed stent. Resistance was not encountered when advancing the devices and excessive force was not used during delivery.   it was reported that the first stent was deployed and then migrated to the proximal rca. The migrated stent was then post-dilated and secured using an nc balloon. The second stent was deployed in the original lesion site but this stent also migrated, distally. Both stents were secured after successive nc dilation. A third resolute onyx stent was then placed between the first two stents. No further patient injury reported.

• 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: 13840052
• MDR Text Key: 287539965
• Report Number: 9612164-2022-01089
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: RONYX27518UX
• Device Catalogue Number: RONYX27518UX
• Device Lot Number: 0010601582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/19/2021
• 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: 03/21/2022 Patient Sequence Number: 1