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

Catalog Number	RONYX40015UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/04/2019
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 4.00x15mm drug eluting stent was intended to be used during a procedure to treat a lesion in the mid rca, exhibiting mild tortuosity and severe calcification.No damage was noted to the packaging.No issues removing the device from the hoop.Device was inspected with no issues.Negative prep was performed with no issues.Device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It is reported that stent dislodged during delivery to the lesion.The device was not kinked or re-straightened during use.Multiple non-medtronic balloons were used to push the stent against the wall.The dislodged stent was then successfully covered with a resolute onyx 4.00x22mm.Post timi flow was 3, and lesion was 0% stenosis at the end of the procedure.No issues is reported for the second stent.

• 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: 8309612
• Report Number: 9612164-2019-00426
• Device Sequence Number: 11197579
• Product Code: NIQ
• UDI-Device Identifier: 00643169557161
• UDI-Public: 00643169557161
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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: 02/22/2020
• Device Catalogue Number: RONYX40015UX
• Device Lot Number: 0009006917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/06/2019
• 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 Weight: 106