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

Catalog Number	RONYX22508UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The target lesion was located in the 1st om and exhibited 80% stenosis prior to pre-dilation (in-stent restenosis of a drug eluting stent).The lesion was pre-dilated.During delivery of the resolute onyx stent that was planned for the 1st om, it dislodged from the balloon within a previously deployed stent in the proximal circumflex.The stent got caught on the guideliner and had to be prematurely deployed in the proximal lcx.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the target lesion had moderate calcium and tortuosity.No difficulties were noted when removing the protective sheath.The device was inspected before use, post-sheath removal, with no issues noted.The lesion was pre-dilated.The inflation device remained on neutral pressure during delivery of the device.The device passed through both a previously deployed stent and cell of a stent.Resistance was noted when advancing the device to the lesions and moderate force was then used.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: patient information 5a & patient race.The stent dislodged in the bifurcation area of the proximal circ and om 1.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: 6886705
• Report Number: 9612164-2017-01306
• Device Sequence Number: 10886513
• Product Code: NIQ
• UDI-Device Identifier: 00643169556690
• UDI-Public: 00643169556690
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 05/23/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2019
• Device Catalogue Number: RONYX22508UX
• Device Lot Number: 0008540218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 11/10/2017; 04/24/2018
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 12/07/2017; 05/23/2018
• 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: 69 YR
• Patient Weight: 129