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

Catalog Number	RONYX40030UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician used a resolute onyx rx coronary drug eluting stent to treat a severely tortuous and calcified lesion located between the left main artery and the obtuse marginal ostium, exhibiting 100% stenosis (cto).There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.It was reported that stent dislodgement occurred during removal following failed delivery.It was described that the physician couldn't cross the lesion, so pulled back on the stent, and described that there were no difficulties apparent during removal.However the physician then saw that only the balloon came out.The stent was left in the left main, un-deployed.The dislodged stent was not removed.It was stated that the physician carried out intervention by passing a non-medtronic balloon through the stent.Four inflations were made to expand the stent in the left main and marginal, starting distally and coming back proximally.The physician completed the procedure and used more stents that were required in the procedure.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
Evaluation 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 patency was verified.No deformation to the distal tip.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7116327
• Report Number: 9612164-2017-01930
• Device Sequence Number: 1119911
• Product Code: NIQ
• UDI-Device Identifier: 00643169557208
• UDI-Public: 00643169557208
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2018

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: 08/25/2019
• Device Catalogue Number: RONYX40030UX
• Device Lot Number: 0008768988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 01/12/2018; 03/05/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/05/2018; 03/29/2018
• 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