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

Catalog Number	RONYX22526UX
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/28/2019
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 rx coronary, drug eluting stent was used to treat a moderately tortuous, severely calcified ostium proximal diagonal branch.The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre dilated.The device did pass through a previously deployed stent.Excessive resistance was encountered when advancing the stent.Excessive force was used during delivery.It was reported that the stent could not cross the lesion.When the device was pulled back, the stent dislodged from the delivery system in the patient's radial artery just above the sheath.A snare was used to remove the stent.Patient is alive with no injury.
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: 8960163
• Report Number: 9612164-2019-03746
• Device Sequence Number: 2860124
• Product Code: NIQ
• UDI-Device Identifier: 00643169556744
• UDI-Public: 00643169556744
• 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): 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/11/2021
• Device Catalogue Number: RONYX22526UX
• Device Lot Number: 0009691869
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 09/04/2019
• 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
• Patient Weight: 82