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

Lot Number UNKNOWN

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4)-unique stent design with continuous cobalt wire can avoid protruding immediately after percutaneous coronary intervention compared to classical tubed stent https://doi.Org/10.1093/eurheartj/ehy566.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study was to evaluate the difference of the protrusion estimated by (b)(6) between r-zes and other kinds of tubed stents.Thirty lesions had r-zes and 106 lesions had classical tubed stents.There was no significant difference in the baseline characteristics including the frequency of acute coronary syndrome (acs) and the main plaque component estimated by oct.Maximum distance of irregular protruding was lower in r-zes compared to tubed stents.Other abnormal findings such as edge dissection, malapposition and under-expansion were similar between the two groups.The study concluded that r-zes with unique design with the continuous wire that is molded into a sinusoidal wave and wrapped in a helical pattern can avoid the intra-stent irregular protrusion, especially for acs lesions.

• Brand Name: RESOLUTE INTEGRITY 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: 8683014
• MDR Text Key: 147473180
• Report Number: 9612164-2019-02255
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2019
• 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