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 Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	02/28/2019
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 one resolute onyx rx coronary drug eluting stent to treat a severely tortuous and calcified lesion in the ostium of the left anterior descending (lad) artery.There were abnormalities reported in relation to the patient anatomy, that there was a sharp 90 degree takeoff.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated several times with a semi compliant balloon.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that the several attempts were made cross the lesion using the resolute onyx stent without success.During removal of the device, the stent dislodged off the balloon in the ostial lad.The stent was retrieved and located in the catheter.It is indicated that the event was due to the complexity of the anatomy and the device was not at fault.The patient is reported as alive with no injury.
Additional Manufacturer Narrative
The resolute onyx was the second stent attempted to pass to an area of dissection after balloon inflation.The device would not pass through a previously deployed stent.The lesion was pre-dilated several times with a non-medtronic semi compliant balloon.During removal of the device, the stent dislodged off the balloon in the ostial lad, and was left behind in the cx.The undeployed stent was removed back into the guide catheter.All devices were removed from the patient without further complications.Patient was admitted to critical care to be observed.Ref: mw5084603.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: an angiographic image was provided which appears to show a dislodged stent in a guide catheter.Image review: an image of the packaging pouch and hoop were provided showing the stent size, batch and length as reported by the account.Two images were provided showing what appears to be the complaint device dislodged stent on a gauze.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: 8386353
• Report Number: 9612164-2019-00755
• Device Sequence Number: 2326988
• Product Code: NIQ
• UDI-Device Identifier: 00643169556621
• UDI-Public: 00643169556621
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2019

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: 04/15/2020
• Device Catalogue Number: RONYX20008UX
• Device Lot Number: 0009086236
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 03/20/2019; 06/07/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 04/19/2019; 06/13/2019
• 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