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

Model Number	RONYX20008UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2018
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
During the procedure an attempt was made to use two resolute onyx rx coronary drug eluting stents (ronyx20015ux) and (ronyx20008ux) to treat a moderately tortuous and non- calcified lesion located in the mid/distal ramus exhibiting 70% stenosis.There were no abnormalities in relation to the anatomy.There was no damage noted to packaging.There were no issues noted when removing devices from the hoop.The devices were inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.There was an initial 99% sub totaled lesion of the proximal ramus intermedius branch.A 2.25x15mm onyx was successfully deployed, a residual 70% stenosis was noted distal to the original stent.This lesion was pre-dilated with a semi compliant balloon, the 2.0x15mm onyx was then attempted to pass through the previously deployed stent without success, a stent strut was noted to be lifted upon removing the stent.A non-medtronic extension catheter was introduced to give more support.Then the 2.0x8mm onyx was attempted to pass through the previously deployed stent without success and again a stent strut was noted to be lifted upon removal of the stent/delivery system.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis summary: the stent was positioned on the balloon between the marker bands but was not meeting specification due to deformation at the distal end.Deformation was evident to the 1st distal stent wraps with struts raised.Deformation was evident to the distal tip.The 0.015 inch mandrel would not load through the guidewire lumen due to hardened blood in the guidewire lumen.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: 7904808
• Report Number: 9612164-2018-02511
• Device Sequence Number: 1683088
• Product Code: NIQ
• UDI-Device Identifier: 00643169556621
• UDI-Public: 00643169556621
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/15/2018

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: 01/02/2020
• Device Model Number: RONYX20008UX
• Device Lot Number: 0008933671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR