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

Catalog Number	RONYX27526UX
Medical Device Problem Codes	Inflation Problem (1310); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Two resolute onyx rx coronary drug eluting stents were intended to be used in an index procedure to treat a lesion in the mid left anterior descending (lad) artery.It was indicated that two stents were attempted to be used.It was reported that the resolute onyx (27.5 x 26 mm) stent was unable to be deployed and was removed intact.The resolute onyx (2.75 x 34 mm) stent was deployed at 9atm for 15 seconds.The procedure was completed using another resolute onyx stent of a bigger size (rony x 5.0 x 15u x).The patient is alive with no injury.
Additional Manufacturer Narrative
The site indicated that the stent size was not appropriate for the lesion and therefore was removed intact.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
It was reported that the stent would not inflate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8844843
• Report Number: 9612164-2019-03129
• Device Sequence Number: 14010734
• Product Code: NIQ
• UDI-Device Identifier: 00643169556928
• UDI-Public: 00643169556928
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2019

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: 08/20/2019
• Device Catalogue Number: RONYX27526UX
• Device Lot Number: 0008761260
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/05/2019; 11/01/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/12/2019; 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 86