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

Model Number	RONYX27530UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: a kink was evident on the hypotube.The stent was not present on the balloon and did not return for analysis.The balloon folds were expanded; the balloon had been inflated.The inner member appeared kinked.Crimp impressions were visible on the exposed balloon surface.The inner lumen patency was verified with a 0.015 inch mandrel.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a lesion.It was reported that there was a kink on the distal shaft and the hypotube.It was also reported that there was no stent on the balloon.No patient injury was reported.Upon analysis it was noted that the balloon had been inflated and this may have occurred in vivo.It was indicated that the stent dislodged off the balloon in vivo.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 9971517
• Report Number: 9612164-2020-01600
• Device Sequence Number: 18999356
• Product Code: NIQ
• UDI-Device Identifier: 00643169556935
• UDI-Public: 00643169556935
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2019
• Device Model Number: RONYX27530UX
• Device Catalogue Number: RONYX27530UX
• Device Lot Number: 0008822107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1