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

Catalog Number	RONYX20008UX
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2018
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
The patient presented with a stemi.An attempt was made to use three resolute onyx rx coronary drug eluting stents to treat a significantly tortuous, mildly calcified lesion exhibiting 100% stenosis located in the 1st diagonal branch.The devices were inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.It is indicated that after pre-dilation there was 50% stenosis remaining.The devices did not pass through previously deployed stents.It is stated that a significant amount of force was used during attempt to deliver.It is stated that a supportive guidewire and also a guideliner were used in the attempt to cross the lesion.It was reported that all three stents were attempted to be used but all failed to cross the lesion.Upon removal of the 2.0x22mm and 2.0x12mm stents, stent deformation was observed.It was reported that while attempting to remove the 2.0x8mm stent following failed delivery that it dislodged inside the guide liner catheter.It is indicated that the stent was never lost in the patient, it was off of the stent delivery system after withdrawal from the body.No adverse effects to the patient reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the dislodged stent returned for analysis.Deformation was evident to the dislodged stent.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage was evident to the remainder of the delivery system.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: 8251913
• Report Number: 9612164-2019-00199
• Device Sequence Number: 2189721
• Product Code: NIQ
• UDI-Device Identifier: 00643169556621
• UDI-Public: 00643169556621
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/17/2019

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: 04/11/2020
• Device Catalogue Number: RONYX20008UX
• Device Lot Number: 0009080949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Initial Date Received by Manufacturer: 12/31/2018
• Supplement Date Received by Manufacturer: 03/26/2019; 04/12/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 04/12/2019; 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR