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

Catalog Number RONYX25022X

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the stent was not present on the balloon of the delivery system and was not returned for analysis.There was no damage evident to the distal tip of the delivery system.Crimp impressions were slightly visible along the balloon working length as the balloon had been inflated.No other damage was noted on the delivery system.Image review: images show a cto in the proximal to mid lcx.There appears to be a degree of calcification at the level of the lesion site.The first device evident in the vasclature shows no evidence of a stent on the delivery system.The account confirmed that this is the complaint device; the stent was not present on the device when it was introduced into the vasclature.There is no evidence of a stent dislodgement from the delivery system within the vasclature.The procedure images provide no evidence as to the root cause of the stent slippage prior to insertion of the device into the patient.(b)(4).

Event Description

It was reported the physician was attempting to use a resolute onyx drug eluting stent to treat a lesion in the mid cx.The device was removed from its packaging as per ifu with no issues noted.Device was removed from the hoop with no issues noted.The protective sheath was removed with no issues noted however the stent was not inspected post removal of the sheath.During the procedure, the physician inflated the balloon but the stent was not visible on fluoro.The physician searched throughout the patient's anatomy for the stent from the arm through the aorta and beyond without any sign of the stent.No patient injury reported.The procedure was completed with another unidentified stent.

• 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: 5716661
• MDR Text Key: 47202681
• Report Number: 9612164-2016-00569
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P110013
• 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
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2017
• Device Catalogue Number: RONYX25022X
• Device Lot Number: 0007601033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2015
• 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