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

Catalog Number	RONYX20018W
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lesion had 90% stenosis, moderate tortuosity and mild atherosclerosis.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.
Additional Manufacturer Narrative
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 a resolute onyx otw coronary drug eluting stent to treat a severely tortuous, severely calcified lesion.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that the first attempt to cross the lesion failed.Upon inspection after removal of the device, the stent was noted to be deformed.The patient was reported to be alive with no injury.

• Brand Name: RESOLUTE ONYX OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9202207
• Report Number: 9612164-2019-04402
• Device Sequence Number: 409187
• Product Code: NIQ
• UDI-Device Identifier: 00643169602175
• UDI-Public: 00643169602175
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2019

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: 05/16/2020
• Device Catalogue Number: RONYX20018W
• Device Lot Number: 0009146751
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/18/2019; 12/10/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/11/2019; 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 71