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

Catalog Number	RONYX27508UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 2.75 x 8mm resolute onyx drug eluting stent was intended to be used to treat a non-calcified lesion in the ostium of the lima graft.Tortuosity was mild.The lesion had 60% stenosis.No damage was noted to packaging.The lesion was pre-dilated with a 2.25 x 8mm non-mdt balloon.The device was inspected with no issues.Negative prep was performed with no issues.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.Excessive force was not used.The resolute onyx stent was inflated once to 14 atm for 26 secs.The stent was postdilated with a 3.0 x 8mm non-mdt nc balloon three times at 16 atm and 20 atm.Post deployment, stent deformation was noted on the right side of the stent not far from proximal edge of stent.While advancing the non-mdt guide catheter, the guide engaged the stent at the proximal edge on the left side of the stent, and pot entially deformed the left side of the stent in same area near proximal edge.Ivus revealed possible gaps in strut coverage of lesion.To fix the deformation, a 3.0 x 8mm non-mdt stent was advanced.This appeared to improve the appearance of stent coverage, although one side of stent strut area still appeared mildly deformed.Patient status is alive with no injury.
Additional Manufacturer Narrative
Image review: review of the procedural images provided confirm the presence of a stenotic lesion in the ostium of the lima graft.Images provided can confirm that stent was deployed in the ostium of the lima.There is no evidence of the balloon inflation.Images provided can confirm that guide was interfering with the right proximal edge of the stent and can also confirm the stent deformation on the right side of the stent near the proximal edge of the stent it was reported that the lesion was predilated and that the device did not pass through a previously-deployed stent but there is no evidence of that on the images.It was reported that there was no resistance while advancing device.Stent was inflated once and then was post-dilated with a balloon three times but there is no evidence in the images provided.It was reported that post deployment the stent deformation was noted on the right side of the stent near the proximal edge of the stent.While advancing the catheter the guide engaged the left side of the proximal edge of the stent and potentially deformed the left side of the stent in same area near proximal edge of the stent.Nevertheless, the images can confirm interference of the guide catheter with the right side of the proximal edge of the stent what can be the potential reason of the stent deformation.There is the evidence of the stent deformation on the right side of the stent near the proximal edge of the stent but there is no evidence of the stent deformation on the left side of the stent.The images provided cannot confirm the time order of the events since the time wasn¿t displayed on the images.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.

• 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: 7360941
• Report Number: 9612164-2018-00542
• Device Sequence Number: 107124
• Product Code: NIQ
• UDI-Device Identifier: 00643169556874
• UDI-Public: 00643169556874
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2019
• Device Catalogue Number: RONYX27508UX
• Device Lot Number: 0008877850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 07/11/2018; 08/08/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 07/23/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 72