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	12/21/2017
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
The physician intended to use a resolute onyx rx drug eluting stent to treat a severely calcified and non-tortuous lesion located at the mid circumflex artery exhibiting 99% stenosis.The anatomy was described as difficult.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device inspected with no issues noted.There were no difficulties noted when removing the protective sheath.The stent was not inspected post removal of the protective sheath.Negative prep was performed with no issues noted.The lesion was pre-dilated.The inflation device remained on neutral pressure during delivery of the device.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device and excessive force was used during delivery.It was reported that stent dislodgement occurred during delivery to/at lesion.The stent was removed using a snare.Patient status post procedure is alive with no further injuries.
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: 7203386
• Report Number: 9612164-2018-00097
• Device Sequence Number: 11020183
• Product Code: NIQ
• UDI-Device Identifier: 00643169557208
• UDI-Public: 00643169557208
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 02/08/2018

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?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/08/2018
• 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: 55 YR
• Patient Weight: 105