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

Catalog Number	RONYX27522UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a resolute onyx drug eluting stent to treat a severely calcified lesion in the right posterior descending (r-pda) artery within the right coronary artery (rca).There was no damage noted to the device packaging and no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was used during delivery.It was reported that stent dislodgement occurred during delivery to the lesion.The dislodged stent was not removed and remains in the patient.No injury was reported.
Additional Manufacturer Narrative
Additional information: the dislodged stent remains in a small branch of the left renal artery.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: the returned procedural images capture the patient lesion condition as reported by the account.The image captures the pre-dilation of the rca.Attempted delivery of the complaint device is visible in the returned images, the next image captures the dislodged stent immediately distal to the guide catheter tip.Additional pre-dilation was carried out followed by successful stent implantation of an unknown stent.An image captures the dislodged stent which had moved from the original dislodged location.No intervention was captured to remove the dislodged stent.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: 7285462
• Report Number: 9612164-2018-00385
• Device Sequence Number: 19089803
• Product Code: NIQ
• UDI-Device Identifier: 00643169556911
• UDI-Public: 00643169556911
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2018

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: 02/07/2019
• Device Catalogue Number: RONYX27522UX
• Device Lot Number: 0008487474
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 03/12/2018; 05/22/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/04/2018; 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 96