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

Catalog Number	RONYX30018W
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
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 lesion.It was reported that the stent failed to cross the lesion and the stent was damaged.Stent struts were found to be sticking out.No patient injury reported.
Additional Manufacturer Narrative
Additional information: patient details - there was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with issues.It is reported that after the device was removed from the hoop it was noted to have a lifted strut.The device was not used in the patient.The procedure was completed using another resolute onyx device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: stent was positioned between the marker bands but not meeting specifications due to deformation of the proximal marker bands.Deformation was evident to the 1st and 2nd proximal stent wraps with struts raised.Proximal stent od = 0.071 inches; mid stent od =0.039 inches; distal stent od =0.041 inches.Specification =0.055 inches max.No deformation was evident to the distal tip.The inner lum en patency was verified with a 0.015 inch mandrel.A protective sheath of similar dimensions to that used during the manufacturing of this batch could not be placed over the stent due to the deformed stent struts.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Photo 1: image shows the distal portion of a device.Deformation is evident to the proximal stent wraps.Deformation was evident to the 17th and 18th distal stent wraps with struts raised.If information is provided in the future, a supplemental report will be issued.

• 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: 7955569
• Report Number: 9612164-2018-02712
• Device Sequence Number: 18939440
• Product Code: NIQ
• UDI-Device Identifier: 00643169602519
• UDI-Public: 00643169602519
• 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): 01/15/2019

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: 04/18/2020
• Device Catalogue Number: RONYX30018W
• Device Lot Number: 0009092071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/16/2018; 11/21/2018; 12/20/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/12/2018; 12/11/2018; 01/15/2019
• 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: 95