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

Catalog Number	RONYX22526UX
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2018
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
A resolute onyx device was attempted to be used to treat a moderately tortuous, severely calcified lesion with 85% stenosis in the ostium of the diagonal branch.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated using a 2.25 x 20 mm non-mdt balloon.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.The pre-dilatation balloon had difficulty crossing the lesion.It is reported that the stent made the turn in the diagonal about 4mm and stopped; the stent could not be advanced.When it was removed from the patient, deformation at the tip was observed.The procedure was completed using a 2.25 x 20 mm non-mdt poba device.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Product analysis summary: stent was positioned between the marker bands but not meeting specifications due to deformation of the distal wraps.Deformation was evident to the 1st ¿ 4th and slight deformation to the 16th distal stent wraps with struts raised.No deformation was evident to the distal tip.The inner member was bunched immediately proximal to the proximal marker band.The inner lumen could not be verified with a 0.015 inch mandrel, most likely due to hardened blood in the guidewire lumen.Slight bends are evident on the shaft of the device immediately distal to the luer 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: 7734250
• Report Number: 9612164-2018-01904
• Device Sequence Number: 19095247
• Product Code: NIQ
• UDI-Device Identifier: 00643169556744
• UDI-Public: 00643169556744
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/22/2019

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: 12/08/2019
• Device Catalogue Number: RONYX22526UX
• Device Lot Number: 0008914166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/19/2018; 01/17/2019
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/02/2018; 11/06/2018; 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR