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

Device Problems Activation, Positioning or Separation Problem (2906); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2018

Event Type  malfunction  

Manufacturer Narrative

Previously reported stent malapposition occurred in 11 cases.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.

Manufacturer Narrative

Journal article: short-term stent coverage of second-generation zotarolimus-eluting durable polymer stents: onyx one-month optical coherence tomography study journal: advances in interventional cardiology, year: 2019, ref: doi.Org/10.5114/aic.2019.86009.Age: average age.Sex: majority gender.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

The present optical coherence tomography (oct) study analyzed the coverage rate at 30 days after implantation of resolute onyx zotar olimus-eluting stents in 15 patients who underwent percutaneous coronary intervention.All patients were treated with dual antiplatelet therapy during the entire duration of the study.The resolute onyx stents were implanted in the following locations: the left anterior descending artery, the circumflex artery; the right coronary artery and the left main coronary artery.At 1-month follow-up stent malapposition and in-stent area obstruction by neointima were reported.One patient required bailout stenting with an 2.5 x 11 mm non medtronic stent to treat distal stent edge vessel dissection.The main finding of this study is that the resolute onyx zes had a very high rate of strut coverage at 30 days.

• 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: 9489998
• MDR Text Key: 188148247
• Report Number: 9612164-2019-05230
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 01/22/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 11/28/2019; 12/27/2019
• Supplement Dates FDA Received: 12/19/2019; 01/22/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR