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

Catalog Number	RONYX25008UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
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 lesion.There was no damage noted to the packaging.The device was inspected with no issues noted.Negative prep was performed with no issues.It was reported that the stent was unable to cross the lesion, the delivery system was removed and the physician realized that the stent was not on the balloon delivery system.It was reported that the stent was located in the guide catheter and a snare was used to removed it.The patient is alive with no injury.
Additional Manufacturer Narrative
Additional information: the stent was not present on the balloon and did not return for analysis.The balloon folds were expanded.Crimp impressions were visible on the exposed balloon surface.The inner lumen patency was verified with a 0.015 inch mandrel.Deformation was evident to the distal tip.There was no other damage evident to the remainder of the delivery system.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: 8854511
• Report Number: 9612164-2019-03200
• Device Sequence Number: 19308797
• Product Code: NIQ
• UDI-Device Identifier: 00643169556782
• UDI-Public: 00643169556782
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/16/2019

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: 12/11/2020
• Device Catalogue Number: RONYX25008UX
• Device Lot Number: 0009489484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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