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

Model Number RONYX27515UX

Device Problems Deflation Problem (1149); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Event Description

Elderly male to emergency department with active chest pain.During the heart cath, stent did deploy but the balloon did not deflate.No known harm to patient.

• Brand Name: RESOLUTE ONYX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 10332039
• MDR Text Key: 200610391
• Report Number: 10332039
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556898
• UDI-Public: (01)00643169556898(17)220201(10)0010119946
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RONYX27515UX
• Device Lot Number: 0010119946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 66