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

Catalog Number	RONYX40008UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
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, attempts were made to use two resolute onyx drug eluting stents to treat a severely tortuous and calcified lesion, located in the proximal right coronary artery.There were no abnormalities in relation to anatomy.There was no damage noted to packaging.The devices were inspected with no issues identified.The lesion was pre-dilated.The devices did pass through a previously-deployed stent.Resistance was encountered when advancing the devices.It was reported that one medtronic stent (3.5x38 resolute onyx) was successful implanted in the rca.An attempt was then made to push a 4.0 x 08 resolute onyx des distal to the first stent.However, the device could not pass through the deployed stent.The 4.0 x 08 device was then removed and lifted struts were noted in the middle of the stent.A guideliner was used and another attempt was made to use another resolute onyx 4.0x8.However the same problem occurred.The device could not cross the deployed stent and the stent was then noted to be deformed.The procedure was completed using a balloon.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: the stent was positioned on the balloon between the marker bands but not meeting specifications due to the deformation of proximal stent wrap.Deformation was evident to the 7th, 8th and 9th distal stent wraps with struts raised, bunched and stretched.No deformation was evident to the distal tip.A kink was evident on the distal shaft 14.4cm proximal to the distal tip.The inner lumen patency could not be verified with a 0.015 inch mandrel most likely due to hardened blood.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: 7547750
• Report Number: 9612164-2018-01245
• Device Sequence Number: 1438820
• Product Code: NIQ
• UDI-Device Identifier: 00643169557147
• UDI-Public: 00643169557147
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/18/2018

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: 08/28/2019
• Device Catalogue Number: RONYX40008UX
• Device Lot Number: 0008772767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 05/28/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1