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

Model Number	RONYX22512UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/30/2019
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
The patient presented with a stemi.An attempt was made to use a resolute onyx rx coronary drug eluting stent (2.25 x 12) to treat a lesion at the ostium of the left anterior descending (lad) artery/diagonal branch.The lesion exhibited mild tortuosity and severe calcification with 100% stenosis.The device was inspected, and negative prep was carried out prior to use with no issues noted.A launcher guide catheter was used to engage the vessel.Pre-dilation of the lad/diagonal and ramus was carried out.Resistance was encountered when advancing the device however excessive force was not used.Following pre-dilation an attempt was made to deliver the resolute onyx stent to the lad/diagonal.During delivery to the lesion the stent dislodged.An attempt was made to advance a euphora balloon (1.5 x 12) to the dislodged stent however the euphora could not be delivered.Following advancement of a third guidewire and non-medtronic balloon the stent was crushed in the lad/diagonal a resolute onyx rx (3.0 x 26) coronary drug eluting stent was then advanced to the ramus.The device was inspected, and negative prep was carried out prior to use with no issues noted.Resistance was encountered when advancing the device however excessive force was not used.The device was unable to cross the lesion.Following removal it was observed that the stent was deformed.An nc euphora balloon was advanced and inflated and another non-medtronic stent was implanted in the ramus no patient injury reported.
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: 9271770
• Report Number: 9612164-2019-04620
• Device Sequence Number: 18872905
• Product Code: NIQ
• UDI-Device Identifier: 00643169556706
• UDI-Public: 00643169556706
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/28/2020

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: 12/08/2019
• Device Model Number: RONYX22512UX
• Device Catalogue Number: RONYX22512UX
• Device Lot Number: 0008914279
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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: 82 YR
• Patient Weight: 86