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

Catalog Number	RONYX20018UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
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 an attempt was made to use one resolute onyx des to treat a lesion in the ostial rca.It was reported that the stent failed to cross the lesion and fell off balloon before deployment.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: patient presented with heavily diseased ostial and distal rca.  this included mild to moderate disease in the mid rca.  all three rca lesions had csi atherectomy performed without complication.The ostial rca was stented first with an ronyx35012, and post dilated with and nceup4008x, with no complication.  the mid rca lesion was not ballooned or stented.The reported resolute onyx was inspected before use.No issues were noted when removing the protective sheath.The stent was inspected post sheath removal with no issues noted.The lesion was pre-dilated before use.During attempted delivery, the stent passed through the previously deployed ostial resolute onyx without difficulty.Resistance was noted when advancing the device to the lesion.Upon several attempts to stent and cross the distal rca, with the 2.0 onyx, the stent would not cross.Upon removal of the 2.0 onyx, a stent strut caught the distal edge of the previously placed ronyx35012ux, and came off the balloon.  subsequently the 2.0 onyx was ballooned/crushed against the wall of the proximal rca distal to the previously placed ostial ronyx35012ux.At the point where it came off the stent balloon.No patient injury was reported.The patient went home as originally planned and no complications to date.Medical history: patient is obese patient gender information updated.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: 8854142
• Report Number: 9612164-2019-03192
• Device Sequence Number: 1903782
• Product Code: NIQ
• UDI-Device Identifier: 00643169556652
• UDI-Public: 00643169556652
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2020
• Device Catalogue Number: RONYX20018UX
• Device Lot Number: 0009163769
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 09/16/2019
• 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