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

Catalog Number	RONYX20008UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/06/2019
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 moderately tortuous, moderately calcified lesion exhibiting 90% stenosis located in the proximal obtuse marginal (om).The device was inspected with no issues noted.Negative prep was not performed.The lesion was not pre-dilated.The device passed through a previously deployed stent.Excessive force was used during delivery.It was reported that stent dislodgement occurred during delivery to the lesion.The stent was unable to be removed and a balloon was inserted in an attempt to crush the stent against the vessel wall.The dislodged stent remains in the patient.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.
Additional Manufacturer Narrative
Additional information: there were no issues noted when removing the protective sheath.Resistance was encountered advancing the device to the lesion.The inflation device remained on neutral pressure during delivery of the device.The attempt to crush the stent against the vessel wall was unsuccessful.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: 9308991
• Report Number: 9612164-2019-04712
• Device Sequence Number: 10860367
• Product Code: NIQ
• UDI-Device Identifier: 00643169556621
• UDI-Public: 00643169556621
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2020

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: 04/27/2021
• Device Catalogue Number: RONYX20008UX
• Device Lot Number: 0009712686
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 12/13/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/06/2019; 01/10/2020
• 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: 76 YR