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

Model Number RONYX30015U

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/15/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, an (b)(6) male patient underwent a cardiac cath with des placement to the rca and pda.During the procedure, a stent was dislodged from the balloon and migrated in to the small hypogastric branch off the right iliac artery.Due to its location, no further intervention was pursued.The patient tolerated the procedure.The patient was discharged on (b)(6) 2018.

• Brand Name: MEDTRONIC RESOLUTE ONYX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55435
• MDR Report Key: 7645667
• MDR Text Key: 112788604
• Report Number: MW5078125
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2020
• Device Model Number: RONYX30015U
• Device Lot Number: 0008997536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 96