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

Catalog Number	RONYX22522UX
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	08/09/2019
Type of Reportable Event	Malfunction
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 lesion.The device was inspected with no issues noted.Negative prep was performed with no issues.It was reported that the stent dislodged during delivery.The lesion was pre dilated again with a 2.0 x 20mm balloon and then was re stented.The dislodged stent was removed.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the device was used to treat a non-tortuous, non-calcified lesion with 75% stenosis in the mid circumflex.The lesion was not pre-dilated initially.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device but excessive force was not used.The stent failed to cross the lesion and after multiple attempts it was decided to remove the stent in order to pre-dilate the lesion.It was reported that when removing the stent through the 6f sheath the stent dislodged.The dislodged stent was removed.The lesion was pre-dilated using a 2.0x20 mm balloon and another stent of the same size was deployed successfully.No further patient injury reported.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: 8892064
• Report Number: 9612164-2019-03383
• Device Sequence Number: 11153458
• Product Code: NIQ
• UDI-Device Identifier: 00643169556737
• UDI-Public: 00643169556737
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2019

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: 05/08/2020
• Device Catalogue Number: RONYX22522UX
• Device Lot Number: 0009135074
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/15/2019; 10/04/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/11/2019; 10/09/2019
• 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: 76 YR
• Patient Weight: 102