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

Model Number	RONYX50030UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the procedure an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous and highly calcified lesion within the saphenous vein graft exhibiting 95% stenosis.There were no abnormalities in relation to the anatomy.There was no damage noted to packaging.There were no issues noted when removing device from the hoop.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre dilated.The device did not pass through a previously-deployed stent.Excessive force was not used during delivery.It was reported that the stent was attempted to be delivered to the lesion.It would not cross and upon removal from the artery the stent edge caught on the edge of the guide catheter and sheared off and dislodged.It was noticed immediately and the stent was snared and removed successfully with no patient injury.
Additional Manufacturer Narrative
The inflation device remained on neutral pressure during delivery of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds remained intact.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.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: 7904715
• Report Number: 9612164-2018-02510
• Device Sequence Number: 13873912
• Product Code: NIQ
• UDI-Device Identifier: 00643169557345
• UDI-Public: 00643169557345
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2019
• Device Model Number: RONYX50030UX
• Device Lot Number: 0008788418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 10/10/2018; 11/26/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/15/2018; 12/12/2018
• 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: 65 YR