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

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Reocclusion (1985); Thrombus (2101); Blood Loss (2597)

Event Date 08/22/2018

Event Type  Injury  

Manufacturer Narrative

Title: six months versus 12 months dual antiplatelet therapy after drug-eluting stent implantation in st-elevation myocardial infarction (dapt-stemi): randomised, multicentre, non-inferiority trial authors: elvin kedhi, enrico fabris, martin van der ent, pawel buszman, clemens von birgelen, vincent roolvink, alexander zurakowski, carl e schotborgh, jan c a hoorntje, christian hasbo eek, stéphane cook,marco togni,martijn meuwissen, niels van royen,ria van vliet, hans wedel, ronak delewi, felix zijlstra journal: the bmj year 2018 issue #: 363 literature reference: http://dx.Doi.Org/10.1136/bmj.K3793.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted documenting that limiting dual antiplatelet therapy (dapt) to six months in patients with event-free st-elevation myocardial infarction (stemi) results in a non-inferior clinical outcome versus dapt for 12 months.Patients presented with stemi were treated with primary percutaneous coronary intervention (pci) and second generation zotarolimus-eluting stent.Medtronic second generation resolute integrity stents were used.Clinical event including death, stroke, stent thrombosis, mi, revas cularisation, and major bleeds were reported in the population during the follow up period.

• 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: 8172968
• MDR Text Key: 130616321
• Report Number: 9612164-2018-03666
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NG
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• 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: 60 YR