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

Catalog Number	RONYX50015UX
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/16/2019
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 a resolute onyx rx coronary, drug eluting stent was used to treat a moderately tortuous, mildly calcified lesion in the first obtuse marginal artery.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was not pre dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The left circumflex came off at a 90 degree angle from a short left main.It was reported that while attempting to advance the stent, the proximal stent was moving in and out of the 6f guide catheter and the stent dislodged.The stent was not removed.It was deployed in the proximal left circumflex with a 3.5 x 15 balloon, then post dilated with a 4.0 and 5.0 balloon.The patient is alive with no other injury.
Additional Manufacturer Narrative
Image review: an image shows a dislodged stent on a guidewire.An image shows a balloon is delivered inside the body of the stent.An image shows the balloon is inflated and the stent is deployed.An image shows a contrast shot after the stent has been deployed.An image shows post dilation of the stent performed.An image shows a balloon is delivered distal to the previous deployed stent.An image shows a stent being delivered.An image shows the stent being deployed.An contrast image shows poor flow to the lcx following stent deployment.An image shows predilation to the proximal lad.An image shows a stent delivered to the proximal lad.An image shows a stent deployed in the proximal lad.A contrast image shows the treated lad.If information is provided in the future, a supplemental report will be issued.
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: 8905347
• Report Number: 9612164-2019-03457
• Device Sequence Number: 2716897
• Product Code: NIQ
• UDI-Device Identifier: 00643169557307
• UDI-Public: 00643169557307
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 12/04/2019

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: 04/03/2021
• Device Catalogue Number: RONYX50015UX
• Device Lot Number: 0009680361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/21/2019; 12/03/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 11/18/2019; 12/04/2019
• 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: 63 YR
• Patient Weight: 156