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

Catalog Number	RONYX20022UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2019
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 one resolute onyx rx coronary drug eluting stent to treat a non-tortuous and non-calcified lesion located in the mid cx artery with 80% stenosis.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.The device did pass through a previously-deployed stent.Excessive force was not used during delivery.It was reported that stent dislodgement occurred during removal following a failed delivery.The device was pulled into the guide catheter and resistance was felt, therefore the guide catheter, guidewire and stent delivery system were removed from the patient.No patient injury was reported.
Additional Manufacturer Narrative
There was no resistance advancing the device to the lesion.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: a kink was evident on the hypotube.Tactile testing confirmed kink.Deformation was evident to the dislodged stent.The balloon folds were expanded.Crimp impressions were visible on the exposed balloon surface.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.There was no other damage evident to the dislodged stent.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: 8637109
• Report Number: 9612164-2019-01928
• Device Sequence Number: 16581522
• Product Code: NIQ
• UDI-Device Identifier: 00643169556669
• UDI-Public: 00643169556669
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 10/15/2019

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: 06/27/2020
• Device Catalogue Number: RONYX20022UX
• Device Lot Number: 0009211606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/06/2019; 10/07/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 07/03/2019; 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 68