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

Lot Number UNKNOWN

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

Date of publication optical coherence tomography predictors for recurrent restenosis after paclitaxel-coated balloon angioplasty for drug-eluting stent restenosis.Doi: 10.1253/circj.Cj-18-0464.If information is provided in the future, a supplemental report will be issued.

Event Description

548 drug-eluting stent (des) in-stent restenosis (isr) lesions were exclusively treated with pcb angioplasty for the first time between september 2008 and december 2016.Medtronic zotarolimus and resolute zotarolimus-eluting stents were among the des that exhibited restenosis.Lesions treated included the left main, lad, left circumflex and right.This study investigated the association between oct findings and mid-term angiographic outcomes.The main findings of the study were: the heterogeneous pattern was associated with recurrent restenosis at follow-up; smaller post-procedural mla, caused primarily by persistent stent under expansion, was also a main cause of recurrent restenosis; and previous stent fracture, heterogeneous pattern, and stent under expansion were independent risk factors for recurrent restenosis.

• Brand Name: ENDEAVOR 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: 8225859
• MDR Text Key: 132358430
• Report Number: 9612164-2019-00104
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060033
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• 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: 12/10/2018
• 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: 69 YR