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

Catalog Number	RONYX27515UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2015
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 a procedure an attempt was made to use a resolute onyx rx coronary, drug eluting stent to treat a calcified lesion in the proximal lad.It is indicated on a non complaint product replacement request form that the stent was deformed and that the stent would not cross the lesion.The procedure was completed with another onyx 2.6mm x 12mm stent.There is no patient injury reported.
Additional Manufacturer Narrative
The lesion was heavily calcified and slightly tortuous with 70% stenosis.No damage was noted to device packaging or issues removing the device from the hoop/tray.The lesion was pre-dilated.During the procedure, the device did not pass through a previously deployed stent.Resistance was encountered during advancement and the device failed to cross.No excessive force was used.The damaged stent was removed.The lesion was dilated with a 2.5 x 12 sc euphora then passed a 2.5 x 12 resolute onyx stent successfully.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: 8678003
• Report Number: 9612164-2019-02234
• Device Sequence Number: 16649492
• Product Code: NIQ
• UDI-Device Identifier: 00643169556898
• UDI-Public: 00643169556898
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

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: 08/30/2019
• Device Catalogue Number: RONYX27515UX
• Device Lot Number: 0008776532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 102