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

Catalog Number RONYX20030X

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure a resolute onyx rx coronary drug eluting stent was used to treat a lesion in the mid left anterior descending artery (lad).It was reported that a stent fracture (type 2) was noted post implantation of the stent.

Manufacturer Narrative

Image review: a short video was provided for analysis.The video appears to show a portion of a guide catheter with the subclavian artery.There is no evidence of a stent fracture in the short video provided.Additional information: the mid lad had 70% stenosis, moderate calcification, and moderate tortuosity.The lesion was pre-dilated.The resolute onyx was implanted to 16atm.The stent was post-dilated to 18atm.It was reported that a stent fracture (type 2) was noted post implantation of the stent, however, it was reported that no device malfunction occurred or is suspected.The patient was discharged the following day.The investigator reviewed the coronary images and disagreed about the stent fracture.There was a heavily calcified area at the middle part of the stent.Also, there is a small branch diagonal two artery draining across at the middle of the stent.The post dilatation balloon was expanded within the allowable limit of the stent.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: 8752328
• MDR Text Key: 149829306
• Report Number: 9612164-2019-02632
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2019
• Device Catalogue Number: RONYX20030X
• Device Lot Number: 0008811108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/05/2019
• Supplement Dates FDA Received: 07/30/2019
• Date Device Manufactured: 09/26/2017
• 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: 68 YR
• Patient Weight: 61