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

Model Number	RONYX22518UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: a dislodged stent returned for analysis, extensive deformation was evident to the entire stent.The delivery system did not return for review.The lot number on inner pouch of the device packaging corresponded with the lot number reported on gch.A photograph of a dislodged stent.Extensive deformation is visible to the entire stent with struts stretched, also what looks to be snare device is attached to the stent.Additional information: the device was inspected before use with no issues noted.The device was prepped per ifu with no issues noted.No resistance was noted during withdrawal of the device and excessive force was not used.The stent was found outside the body once the catheter was removed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: it was reported that a snare was not used to remove the stent.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.
Event or Problem Description
A resolute onyx rx coronary, drug eluting stent was used to treat a very calcified lesion.It was reported that the stent dislodged after removal from the patient and that the catheter delivery system was deformed.The physician used a guide liner and thought the stent was deployed but thinks the calcification and the guideliner made the stent dislodge off the catheter.Another onyx stent was used to treat the lesion.The patient is alive with no injury.

• 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: 9646394
• Report Number: 9612164-2020-00483
• Device Sequence Number: 353820
• Product Code: NIQ
• UDI-Device Identifier: 00643169556720
• UDI-Public: 00643169556720
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/09/2020

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: 07/09/2021
• Device Model Number: RONYX22518UX
• Device Catalogue Number: RONYX22518UX
• Device Lot Number: 0009815547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 03/04/2020; 03/25/2020; 04/08/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/25/2020; 04/03/2020; 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1