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

Catalog Number	RONYX35012UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
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 a resolute onyx rx coronary drug eluting stent to treat a lesion in the ostium in the right coronary artery (rca).It was reported that during insertion to the right ostia lesion the stent dislodged off the balloon.Another balloon was used to inflate the stent.The patient is alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The rca had 99% mid vessel stenosis with heavy calcification.The device was inspected.Negative prep was not performed.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.The stent did not cross the lesion.The lesion had been pre-dilated but the area where the stent dislodged was not pre-dilated.The target lesion was distal, the stent dislodged in the proximal area.When the stent delivery system was withdrawn through the sheath, it was noted that the stent was not on the balloon.The stent remained in proximal rca.Another balloon was used to inflate the stent in the prox rca.Patient left the lab in stable condition.The mid rca was treated with pta resulting in reduction of stenosis from 99 to 60%.The patient returned to the lab approx one week later for stenting of mid rca with a non-medtronic stent via femoral approach and 6 french guide.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: 8763667
• Report Number: 9612164-2019-02705
• Device Sequence Number: 16516415
• Product Code: NIQ
• UDI-Device Identifier: 00643169557062
• UDI-Public: 00643169557062
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2019

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: 12/05/2019
• Device Catalogue Number: RONYX35012UX
• Device Lot Number: 0008908501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/09/2019; 09/03/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 08/07/2019; 09/09/2019
• 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: 79 YR
• Patient Weight: 67