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

Catalog Number RONYX35015UX

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

Product event summary # no dhr review required; does not meet the requirements of (b)(4) for dhr review.(b)(4) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure, 2 resolute onyx rx coronary drug eluting stents were intended to be used to treat a lesion exhibiting 75% stenosis located in the proximal rca.The lesion was pre-dilated.A 3.0x38mm resolute onyx stent was implanted without issue.It was reported that while implanting a 3.5x15mm resolute onyx stent the unknown brand of guide catheter disengaged from the rca resulting in a minor gap between the two stents.Both stents were post dilated at 20atm.A 3.0x8mm resolute onyx was implanted to cover the gap.No patient injury was reported to be associated with this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8310465
• MDR Text Key: 135173271
• Report Number: 9612164-2019-00442
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169557079
• UDI-Public: 00643169557079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2020
• Device Catalogue Number: RONYX35015UX
• Device Lot Number: 0009213680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2019
• Date Device Manufactured: 07/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 36