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

Model Number	RONYX30038UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/24/2020
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 an attempt was made to use two resolute onyx rx coronary drug eluting stent to treat a moderately tortuous, severely calcified lesion exhibiting 100% stenosis located in the mid right coronary artery (rca).The devices were inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre dilated.The devices did not pass through a previously deployed stent.Resistance was not encountered when advancing the 3.00 x 38mm stent.Resistance was encountered when advancing the 3.00 x 30mm stent.Excessive force was not used during delivery of devices.It was reported that stent dislodgement occurred during delivery to/at a lesion.It was stated that the 3.00 x 38mm stent was deployed.An attempt to cross the deployed 3.00 x 38mm stent with the 3.00 x 30mm stent failed and stent dislodgement occurred when attempting to remove the catheter.It was reported that a snare was used to grab the 3.00 x 30mm stent which then entangled with the 3.00 x 38mm stent and both stents were removed using the snare.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: it was stated that it took two inflation attempts to deploy the 3.00 x 38mm onyx stent; 18 atm inflation pressure was applied on first inflation, while 19 atm inflation pressure was applied on second inflation.Post dilation was achieved using a 3.0 x 15mm nc euphora balloon.It was later reported that the 3.00 x 38mm onyx stent deformed when attempting to cross with the 3.00 x 30mm onyx stent.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: 9876763
• Report Number: 9612164-2020-01341
• Device Sequence Number: 14248936
• Product Code: NIQ
• UDI-Device Identifier: 00643169557048
• UDI-Public: 00643169557048
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: RONYX30038UX
• Device Catalogue Number: RONYX30038UX
• Device Lot Number: 0009930819
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 04/03/2020; 04/03/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 04/16/2020; 05/28/2020
• 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: 54 YR
• Patient Weight: 81