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

Catalog Number	RONYX22518UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/21/2019
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 severely tortuosity, severely calcified lesion exhibiting 85% stenosis in the proximal circumflex (cx) artery.The device was inspected with no issues noted.The lesion was not pre dilated.The device did not pass through a previously deployed stent, resistance was encountered when advancing the device.Excessive force was not used during delivery.It is reported that the stent dislodge during delivery to the lesion.A snare had to be used to remove the stent.The patient is reported to be alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Negative prep was not performed.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: 8649202
• Report Number: 9612164-2019-02064
• Device Sequence Number: 16899177
• Product Code: NIQ
• UDI-Device Identifier: 00643169556720
• UDI-Public: 00643169556720
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2019

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: 10/09/2020
• Device Catalogue Number: RONYX22518UX
• Device Lot Number: 0009371177
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 06/05/2019; 08/01/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/01/2019; 08/06/2019
• 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 Age: 77 YR
• Patient Weight: 93