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

Catalog Number	RONYX45022UX
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: no stent was returned with delivery for analysis.The balloon returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, a leak was observed on the balloon distal cone, near the distal marker band.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a short radial tear on the balloon material 0.7cm proximal to the distal tip.The balloon material was jagged and uneven at the tear site.Inner lumen patency was verified.Tip deformation was evident during visual inspection, with tip flared, stretched and tore.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient had previous stents.The physician intended to use a resolute onyx drug eluting stent to treat a mildly tortuous, moderately calcified lesion with 80% stenosis in the proximal right coronary artery.There was no damage noted to packaging.There were no issues when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.Inflation difficulties were reported and the balloon burst during stent deployment after 6atm of pressure was applied.The stent was not fully expanded and was subsequently deployed using two non-mdt balloons.The device was not moved or re-positioned in the lesion prior to the burst.The burst occurred on the first inflation of the device and there was a sudden drop in pressure.The device passed through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The device was implanted and remains in the patient.The patient is alive and there is no patient injury reported post procedure.
Additional Manufacturer Narrative
Image review: review of the procedural images confirm the calcified nature of the rca vessel.A previously deployed stent is visible in the vessel.The images capture delivery and positioning of the resolute onyx stent across the proximal lesion.On pressurization of the delivery system the distal section of the balloon does not expand due to the leak.The stent is subsequently expanded and apposed to the vessel wall using other balloons.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: 6900617
• Report Number: 9612164-2017-01338
• Device Sequence Number: 13784182
• Product Code: NIQ
• UDI-Device Identifier: 00643169557260
• UDI-Public: 00643169557260
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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: 02/07/2019
• Device Catalogue Number: RONYX45022UX
• Device Lot Number: 0008487240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 01/26/2018
• 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