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

Catalog Number UNK-CV-GWY-END

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Thrombus (2101); Injury (2348)

Event Date 04/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The aim of this non-randomized, retrospective, observational study was to compare clinical outcomes between a early generation drug eluting stent (edes) and a current generation drug eluting stent (cdes) for percutaneous coronary intervention (pci) with double stent strategy (dss) for unprotected distal left main disease (ulmd).1832 consecutive patients who underwent pci for ulm distal bifurcation lesions were identified at new tokyo hospital (chiba, japan), san raffaele scientific institute and emo-gvm centro cuore columbus (milan, italy) between january 2005 and december 2015.Of them, 452 patients treated with dss were enrolled in this study, including 236 patients treated with edes and 216 treated with cdes.27 dissections were reported which were not included in the final study patient population.Edes implanted in the patient population included 10 endeavor stents and cdes implanted included 45 resolute family stents.Other non-medtronic stents were also implanted within patients of both the edes and cdes groups.The primary endpoint was target lesion failure (tlf) defined as a composite of cardiac death, target lesion revascularization (tlr) and myocardial infarction (mi) during the median follow-up period of 1,809 days.After pci, a lifelong administration of aspirin was prescribed, and clopidogrel or prasugrel was prescribed for at least 12 months, regardless of drug-eluting stent type.Clinical outcomes in both groups included cardiac death, target lesion revascularization (tlr), myocardial infarction (mi), definite/probable stent thrombosis (st).Cardiac mortality, the rate of tlr for lm-lad, mi and definite/probable st did not significantly differ between both groups.Death was considered as cardiac in origin unless obvious non-cardiac causes were identified.The rate of overall tlr was significantly lower in cdes group than that in edes group.

• 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 ; IE ; 091708734
• MDR Report Key: 10096487
• MDR Text Key: 196098253
• Report Number: 9612164-2020-02011
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CV-GWY-END
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2020
• 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: 69 YR