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

Model Number	RONYX30012UX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	03/03/2020
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
During a procedure, one resolute onyx rx coronary drug eluting stent was attempted to be used to treat a severely tortuous, moderately calcified lesion exhibiting 80% stenosis located in the distal right coronary artery (rca).The device was inspected with no issues noted.Negative prep was not performed.The lesion was pre-dilated.The device did pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent dislodgement occurred during delivery to a lesion.It was stated an attempt was made to deliver a resolute onyx stent (3.0 x 38mm) to the distal lesion, however it failed to deliver due to excessive tortuosity.This stent was deployed at the proximal rca lesion.Following this, an attempt was made to deliver a shorter resolute onyx stent (3.0 x 12mm) to the distal lesion, through the freshly deployed resolute onyx stent (3.0 x 38mm), using a guideliner, and this stent dislodged off the delivery system.It was stated that the wire position was lost.Upon re-wiring the rca, it was noticed that the wire was outside the dislodged stent.The stent was implanted by crushing it into the vessel wall with another stent deployed over the top of the dislodged stent.The stent was not removed from the patient.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Product analysis: an angiographic image confirmed a severely tortuous, moderately calcified lesion exhibiting 80% stenosis located in the distal right coronary artery (rca).There was evidence of previously deployed stents in the rca.Balloons were delivered inside the bodies of the deployed stents and multiple post dilations were performed.There were no images capturing the delivery and withdrawal of an undeployed stent in the distal rca.A stent was delivered and deployed in the proximal rca.A dislodged stent was evident in the proximal rca, there were no images capturing the dislodgement occurring.A stent was delivered and deployed in the proximal rca in order to crush the dislodged stent against the vessel wall.The final image showed the treated rca.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.
Additional Manufacturer Narrative
Product analysis summary: the stent was not present on the balloon and did not return for analysis.Crimp impressions were visible on the exposed balloon surface.The balloon folds remained intact.The inner lumen patency was verified with a 0.015 inch.No other damage was evident to the remainder of the device.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: 9785138
• Report Number: 9612164-2020-00998
• Device Sequence Number: 16283518
• Product Code: NIQ
• UDI-Device Identifier: 00643169556973
• UDI-Public: 00643169556973
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 06/15/2020

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: 07/09/2021
• Device Model Number: RONYX30012UX
• Device Catalogue Number: RONYX30012UX
• Device Lot Number: 0009822929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/31/2020; 06/09/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/01/2020; 06/15/2020
• 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: 50 YR
• Patient Weight: 87