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

Catalog Number	RONYX27522UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/25/2018
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 the procedure, an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous and severely calcified lesion located in the proximal left anterior descending artery (lad).There was 95% stenosis.There were no abnormalities in relation to the anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated and pre-treated with rotablator.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device but excessive force was not used during the procedure.It was reported that during removal of the device following a failed delivery the stent dislodged just distal to the non-medtronic guide catheter.The lesion was described as being a "tough" calcified lesion.The dislodged stent was compressed against the guide catheter, when withdrawing the delivery system after the device did not cross lesion.The dislodged stent was then removed from the patient using a snare.The procedure was completed using 2.5x15mm, 2.75x26mm, 3.0x18mm and 3.0x8mm resolute onyx stents.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: the delivery system was not present and did not return for analysis.The dislodged stent returned for analysis.A snare loaded into a guide catheter was received.The dislodged stent returned stretched and bunched.Procedural images:the images capture a lesion site in the lad with 95% stenosis as reported by the account.The delivery and successful deployment of multiple devices are captured.The next set of images captures what appears to be the dislodged resolute onyx stent in the lad distal to the tip of the guide catheter.The stent then appears to be compressed/crushed by an unidentified balloon the next set of images captures the dislodged stent appearing to be protruding into the aorta, from the ostium of the left main.Numerous stents were then used to treat the vessel.The images then capture the treated vessel, with no evidence of the dislodged stent.There were no images capturing the removal of the dislodged stent with the snare.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: 7536518
• Report Number: 9612164-2018-01202
• Device Sequence Number: 2413304
• Product Code: NIQ
• UDI-Device Identifier: 00643169556911
• UDI-Public: 00643169556911
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/12/2018

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: 10/04/2019
• Device Catalogue Number: RONYX27522UX
• Device Lot Number: 0008821768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 09/12/2018
• 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: 79 YR
• Patient Weight: 74