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

Model Number	RONYX45030UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2018
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
An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion exhibiting 90% stenosis located on the rca.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that when the stent exited the guide catheter it was unable to cross the lesion and became hung up on the calcium, the stent was removed from the patient, upon removal it was observed that stent deformation occurred with a strut of the stent becoming lifted.The procedure was completed using a shorter stent.The patient is reported to be alive with no injury in relation to the resolute onyx stent.
Additional Manufacturer Narrative
Product analysis: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 4th distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.Slight bends are evident on the shaft of the device which are consistent with coiling of the device for return.No other damage evident to the remainder of the device.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: 8221330
• Report Number: 9612164-2019-00068
• Device Sequence Number: 13522146
• Product Code: NIQ
• UDI-Device Identifier: 00643169557284
• UDI-Public: 00643169557284
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 01/18/2019

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: 04/30/2020
• Device Model Number: RONYX45030UX
• Device Catalogue Number: RONYX45030UX
• Device Lot Number: 0009119052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 86