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

Catalog Number RONYX30038W

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

One resolute onyx drug eluting stent was intended to be used to treat a severely calcified lesion in the rca with 80% diffuse mid-artery occlusion with thrombosis.The device was inspected with no issues.The lesion was pre-dilated with a 2.0mm x 20mm balloon.Resistance was encountered when advancing the device and excessive force was used.It was reported that the stent failed to cross the lesion and when removed was noted to be deformed.The lesion was then pre-dilated with a 3.0mm x 20mm balloon, guideliner was advanced and a 3.0mm x 38mm onyx stent was successfully placed followed by a more proximal 3.0mm x 38mm onyx stent and then another 3.50mm x 30mm onyx was placed in the proximal segment in the rca.No patient injury is reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: RESOLUTE ONYX OTW
• 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: 7689038
• MDR Text Key: 114543169
• Report Number: 9612164-2018-01736
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169602564
• UDI-Public: 00643169602564
• 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,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Catalogue Number: RONYX30038W
• Device Lot Number: 0008895835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2018
• Date Device Manufactured: 11/28/2017
• 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: 64 YR
• Patient Weight: 114