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

Catalog Number	RONYX27515UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
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
During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a lesion in the mid left anterior descending artery (lad).It was reported that stent deformation occurred after multiple failed attempts to cross the lesion.The procedure was completed using another resolute onyx stent.No patient injury was reported.
Additional Manufacturer Narrative
There was 100% occlusion mid-lad between two stents.Thrombus was present.A 2.5x12mm balloon was used for pre-dilation.The stent would not pass the lesion.A 3x15mm balloon was then used.The stent was still unable to pass the lesion.A 3.5x12mm nc balloon was then used.The procedure was completed using another same sized resolute onyx stent.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: 8623036
• Report Number: 9612164-2019-01816
• Device Sequence Number: 2005378
• Product Code: NIQ
• UDI-Device Identifier: 00643169556898
• UDI-Public: 00643169556898
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/23/2019

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: 04/24/2020
• Device Catalogue Number: RONYX27515UX
• Device Lot Number: 0009106308
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 70