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

Catalog Number	RONYX30034UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombus (2101); Vascular Dissection (3160)
Date of Event	11/14/2019
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 prompted by an acute mi two resolute onyx rx coronary drug eluting stents, 3.0 x 34mm and a 3.0 x 15mm, were used to treat a moderately calcified, moderately tortuous lesion exhibiting 90% stenosis in the mid distal right coronary artery (rca).The devices were inspected with no issues noted.The lesion was not pre-dilated.The devices did not pass through any previously deployed stents.Resistance was not encountered.Excessive force was not used.It was reported that 4-6 hours after the stents were implanted stent thrombosis occurred.Two additional resolute onyx stents, 3.0 x 18mm and a 3.5 x 15mm, were used to treat the stent thrombosis in the proximal rca.It was reported that a dissection occurred in the proximal rca above the 3.00x15mm resolute onyx stent.It was stated that it was unknown if the dissection was caused by a stent or due to anatomy.The patient is stable and doing well in icu.

• 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: 9374952
• Report Number: 9612164-2019-04896
• Device Sequence Number: 3080303
• Product Code: NIQ
• UDI-Device Identifier: 00643169557031
• UDI-Public: 00643169557031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2019

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: 02/13/2020
• Device Catalogue Number: RONYX30034UX
• Device Lot Number: 0008993421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/26/2019
• 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: 63 YR
• Patient Weight: 85