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

Catalog Number	RONYX27526UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/29/2018
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
A resolute onyx drug eluting stent was intended to be used to treat a heavily calcified lesion in the rca.Tortuosity was moderate.Proximal and distal previous stents were present.The distal stent had in-stent restenosis (isr).Negative prep was not performed.The lesion was not pre-dilated.An attempt was made to directly stent the lesion with the resolute onyx.The device was passed through the previously-deployed stent.Resistance was encountered when advancing the device.The device could not cross the distal in-stent lesion.The attempt was a little forceful, but excessive force was not used.The stent catheter was removed and it was noted that the stent had dislodged and was in the vessel.The stent could not be snared.Another stent was used to intentionally trap the resolute onyx stent against the previous stent.The patient was unharmed.Patient status is alive with no injury.
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: 7356717
• Report Number: 9612164-2018-00531
• Device Sequence Number: 19338838
• Product Code: NIQ
• UDI-Device Identifier: 00643169556928
• UDI-Public: 00643169556928
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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: 09/06/2019
• Device Catalogue Number: RONYX27526UX
• Device Lot Number: 0008784744
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 06/28/2018
• 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: 66 YR