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

Catalog Number RONYX25030X

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A radial approach was used.During the procedure resolute onyx drug eluting stents were intended to be used to treat a non-calcified and moderately tortuous lesion located in the 1st om exhibiting 90% stenosis and another lesion located in the mid lad with 99% stenosis, moderate calcification and no tortuosity.The lesions were pre-dilated.It was reported that a resolute onyx (0008932815) was implanted in p-lad.During implantation of a second stent (0008935312) in the lcx, the stent dislodged in the guiding catheter.The sheath tube was pulled out, and the stent moved out with sheath tube.During this process, the second stent (0008935312) was stuck with the first stent (0008932815).Both stents were pulled out of the patient's body, and two new resolute onyx drug eluting stents were successfully implanted.Another resolute onyx drug eluting stent was successfully implanted in the mid lad lesion.There was no adverse event to the patient.

Manufacturer Narrative

Photo image review: photo 1; image shows two dislodged stents.Photo 2; the two stents appear to be stuck together.Photo 3; deformation is evident to both stents with the struts appearing stretched and raised.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

2 resolute onyx drug eluting stents were implanted in the mid lad.One resolute onyx drug eluting stent drug eluting stent was implanted in the 1st om.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: 7662176
• MDR Text Key: 113191182
• Report Number: 9612164-2018-01611
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 10/21/2019

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: 11/08/2019
• Device Catalogue Number: RONYX25030X
• Device Lot Number: 0008932815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 07/04/2018
• Supplement Dates Manufacturer Received: 10/16/2018; 10/11/2019
• Supplement Dates FDA Received: 10/26/2018; 10/21/2019
• Date Device Manufactured: 11/08/2017
• 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: 58 YR
• Patient Weight: 56