MAUDE Adverse Event Report: MEDTRONIC RESOLUTE ONXY-ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Model Number REF # RONYX27522UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Calcium Deposits/Calcification (1758); Embolism (1829)

Event Date 01/11/2018

Event Type  Injury  

Event Description

Patient undergoing cardiac catheterization which was complicated by stent dislodgement off heavily calcified ostial rca lesion.Stent embolized to distal small branch of left renal artery where it remains.

• Brand Name: RESOLUTE ONXY-ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
• Type of Device: RESOLUTE ONXY-ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 7247472
• MDR Text Key: 99347847
• Report Number: MW5075102
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2019
• Device Model Number: REF # RONYX27522UX
• Device Catalogue Number: REF # RONYX27522UX
• Device Lot Number: 0008487474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Weight: 98