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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Infarction, Cerebral (1771); Death (1802); Ischemia (1942); Myocardial Infarction (1969); Patient Problem/Medical Problem (2688)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

Title: temporal course of vascular healing and neoatherosclerosis after implantation of durable- or biodegradable-polymer drug-eluting stents authors: guagliumi, giulio; guagliumi, giulio; shimamura, kunihiro; sirbu, vasile; garbo, roberto; boccuzzi, giacomo; vassileva, ang elina; valsecchi, orazio; fiocca, luigi; canova, paolo; colombo, francesco; tensol rodriguez pereira, gabriel; nakamura, daisuke; attizzani, guilherme f; cereda, alberto; satogami, keisuke; de luca, leonardo; saia, francesco; capodanno, davide; nlm journal: european heart journal year: 2018 issue: 0, 1-10 ref: https://doi.Org/10.1093/eurheartj/ehy273.A2=average, age a3= majority gender, b3=date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

This study was to compare in vivo vessel healing and na of current generation bp- or dp-des using serial optical coherence tomography (oct) assessments.Ninety patients were randomised to this study and resolute integrity drug-eluting stent was implanted in fourty-five patients in the study population.Vessels treated were lad, cx and rca.At 3 months, all randomized patients underwent angiographic and oct follow-up.The rates of covered, uncovered, uncovered and apposed struts were comparable between everolimus eluting stents and zotarolimus eluting stents, with some degree of inter-individual variability in both groups.The vast majority of uncovered struts were completely apposed to the vessel wall 85% in both groups.Clinical events reported at 3-months follow-up are myocardial infarction and target vessel revascularization.Clinical events reported at 2 year follow-up are death (non-cardiac), stroke, mi, target lesion revascularization and ischemia-driven target lesion revascularization.

Manufacturer Narrative

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

• 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: 7669606
• MDR Text Key: 113416050
• Report Number: 9612164-2018-01668
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/04/2018
• 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): Other; Required Intervention
• Patient Age: 64 YR