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

Catalog Number	RONYX40026UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The physician intended using a resolute onyx drug eluting stent to treat a lesion in the mid rca.The lesion had heavy calcium, 90% stenosis, and moderate tortuosity.The device was inspected prior to use with no issues noted.No difficulties were noted when removing the protective sheath.The stent was inspected post removal of the protective sheath 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 or cell of a stent.It is reported that the physician had difficulty crossing the lesion, and attempted to pull the device back.It then dislodged from the delivery system.Excessive force was not used.The physician ballooned and crushed the stent in position, then placed a non-mdt stent.
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: 7208903
• Report Number: 9612164-2018-00120
• Device Sequence Number: 1023134
• Product Code: NIQ
• UDI-Device Identifier: 00643169557192
• UDI-Public: 00643169557192
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/29/2018

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: 07/17/2019
• Device Catalogue Number: RONYX40026UX
• Device Lot Number: 0008711935
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2017
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 01/22/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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