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

Model Number RONYX35018UX

Device Problem Material Deformation (2976)

Patient Problems High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Nausea (1970); Occlusion (1984); No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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.

Manufacturer Narrative

Correction: pma number.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9580183
• MDR Text Key: 174921554
• Report Number: 9612164-2020-00192
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557086
• UDI-Public: 00643169557086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2020
• Date Device Manufactured: 09/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 101