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

Model Number	RONYX35018UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Nausea (1970); Occlusion (1984); No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	12/06/2019
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 located in the proximal lad.It was reported that stent deformation occurred in-vivo.It was informed that the broken mesh was noted after stent insertion upon removal of the device from the patient.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
During a procedure, an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a moderately calcified lesion exhibiting 95% stenosis in the proximal lad.The lesion was pre-dilated with 2 balloon inflation.Patient status is alive with hypertension, shortness of breath, nausea, coronary pressure 8/10, abrupt vessel closure of the distal rca, and stemi.Revascularization was performed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: pma number.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: 9580183
• Report Number: 9612164-2020-00192
• Device Sequence Number: 11574341
• Product Code: NIQ
• UDI-Device Identifier: 00643169557086
• UDI-Public: 00643169557086
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 03/18/2020

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: 09/05/2021
• Device Model Number: RONYX35018UX
• Device Catalogue Number: RONYX35018UX
• Device Lot Number: 0009903620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019; 01/17/2020; 03/16/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 01/13/2020; 02/12/2020; 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 101