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

Catalog Number	RONYX27512UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a resolute onyx drug eluting stent (2.75x12mm) to treat a lesion in the rca.No issues were noted when removing the device from packaging.The device was inspected prior to use with no issues noted.The lesion was pre-dilated.It is reported that the device failed to cross the lesion and a strut lifted while attempting to cross the lesion.No resistance was encountered during advancement, no force was applied.The procedure was completed using a 2.75 x 8mm non-medtronic stent.There is no patient injury.
Additional Manufacturer Narrative
Additional information: the rca lesion exhibited mild calcification product analysis: the stent was positioned on the balloon between the marker bands as per specifications.It was evident that the 1st distal stent wrap had struts misaligned.Although stent meets od dimensional measurement criteria the stent misalignment confirmation is based on the failed visual inspection ¿ stent.Deformation was evident to the distal tip, with tip appearing uneven.The inner lumen patency was verified.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: 6864122
• Report Number: 9612164-2017-01261
• Device Sequence Number: 495739
• Product Code: NIQ
• UDI-Device Identifier: 00643169556881
• UDI-Public: 00643169556881
• 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): 11/03/2017

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: 01/17/2019
• Device Catalogue Number: RONYX27512UX
• Device Lot Number: 0008453537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 72