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

Model Number	RONYX30026UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Several kinks were evident on the hypotube.The stent was not present on the balloon and did not return for analysis.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.Deformation was evident to the distal shaft, distal to the guidewire entry port.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened deformation in the guidewire lumen.The mandrel became trapped in the guidewire lumen and was removed with force that caused damage to the inner member.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use two resolute onyx rx coronary drug eluting stents to treat a moderately tortuous and severely calcified lesion located in the mid cx artery with 70% stenosis.The devices were inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre dilated using a 2.5 x 20 mm euphora balloon twice at 14 atms.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 onyx (lot 0009213660) failed to cross the lesion after two attempts, after the second attempt the stent was removed and stent struts were noted to be sticking up.A second onyx (lot 0009139990) was then attempted to be used but this also failed to cross the lesion and on removal became dislodged inside the touey.A non medtronic stent and a non medtronic balloon catheter were then used but also failed to cross the lesion.The lesion was dilated using a 3.0 x 20 nc euphora balloon andinflated to 24 atms.A 3.0 x 22 resolute onyx then passed the lesion and was successfully deployed the the mid cx.No patient injury was reported.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• MDR Report Key: 10263406
• Report Number: 9612164-2020-02551
• Device Sequence Number: 13696137
• Product Code: NIQ
• UDI-Device Identifier: 00643169557017
• UDI-Public: 00643169557017
• 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
• Report Date (Section B): 07/13/2020

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: 05/12/2020
• Device Model Number: RONYX30026UX
• Device Catalogue Number: RONYX30026UX
• Device Lot Number: 0009139990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 64