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

Catalog Number	RONYX25015W
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/14/2019
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
During a procedure an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a mildly tortuous, moderately calcified lesion located in the mid circumflex (cx) artery.The device was inspected with no issues.Negative prep was performed without issue.Resistance was encountered when advancing the device.It was reported that the stent dislodged during delivery to the lesion while attempting to pass a previously deployed stent.The dislodged stent was crushed in the vessel using another stent.The patient was reported to be alive with no further injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8900555
• Report Number: 9612164-2019-03440
• Device Sequence Number: 13947665
• Product Code: NIQ
• UDI-Device Identifier: 00643169602328
• UDI-Public: 00643169602328
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/22/2019

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: 11/29/2020
• Device Catalogue Number: RONYX25015W
• Device Lot Number: 0009462833
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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