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

Model Number	RONYX35018UX
Date of Event	07/21/2020
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 resolute onyx des was used during a procedure to treat a none tortuosity, none calcified proximal saphenous vein graft (svg).The device was removed from the hoop with no issues.The device was inspected with no issues.The lesion was pre dilated.The device did pass through a previously deployed stent.Resistance was not encountered.Excessive force was not used.It was reported that the s tent became flared on the proximal end and couldn't be delivered, when they went to retract the stent they could not pull it into the guide catheter.The stent was withdrawn to the sheath but was unable to be removed through the subcu tissue.Surgical forceps was used to removed the device through the sheath channel.Patient suffered some post opp bleeding.The patient is alive with no further injury.
Additional Manufacturer Narrative
Image review: two angiographic images were provided for review.The first image is an angiographic image showing a stent delivered to the proximal vessel.The stent is in place on the balloon.Flaring of the proximal stent i.E.Deformation is visible on the proximal end of the stent where it is located immediately distal to the tip of the guide catheter.The possibility exists that the proximal end of the stent caught on the tip of the guide during advancement and retraction activities.Or the possibility exists that pressure was inadvertently exerted on the delivery catheter resulting in partial expansion of the proximal balloon that in turn resulted in partial expansion of the proximal stent.Either scenario cannot be confirmed from the procedural images.The second image is of an angiographic image of the dislodged stent on a wire in what appears to be the iliac artery, when the dislodged stent is being removed from the vessel.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
Device evaluation summary: device returned for evaluation.The stent was not present on the balloon and did not return for analysis.The balloon folds remained intact.Crimp impressions were visible on the exposed balloon surface.No deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.There was no damage evident to the remainder of the delivery system.Additional information: stents were previously placed in the vein graft.It was indicated that the procedure was completed with no additional stents used.It was later indicated that stent dislodgement occurred during withdrawal of the device.Correction: adverse event and product problem selected patient code - c50470, device code - c63228.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 10338042
• Report Number: 9612164-2020-02789
• Device Sequence Number: 19577859
• Product Code: NIQ
• UDI-Device Identifier: 00643169557086
• UDI-Public: 00643169557086
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/01/2020

1 Device 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: 05/20/2022
• Device Model Number: RONYX35018UX
• Device Lot Number: 0010251213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/29/2020; 08/27/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/24/2020; 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No