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 Death (1802); Myocardial Infarction (1969); Sudden Cardiac Death (2510)

Event Date 05/23/2018

Event Type  Death  

Manufacturer Narrative

Title: two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised bio-resort trial authors: marlies m.Kok, md; paolo zocca, md; rosaly a.Buiten, md; peter w.Danse, md, phd; carl e.Schotborgh, md; martijn scholte, md; marc hartmann, md, phd; martin g.Stoel, md, phd; k.Gert van houwelingen, md; gerard c.M.Linssen, md, phd; carine j.M.Doggen, phd; clemens von birgelen, md, phd journal: eurointervention year:2018 issue: 14 ref: doi: 10.4244/eij-d-18-00336.Age/date of birth=average age.Sex= majority gender.Date of event=date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

Resolute integrity drug-eluting stent was implanted in 1,173 patients in the study population.Patients were on dapt for 12-months and followed a stringent dapt discontinuation policy after one year.The primary composite endpoint of target vessel failure (tvf) assessed device efficacy and patient safety and consisted of cardiac death, target vessel-related myocardial infarction (mi), or clinically indicated target vessel revascularisation.Secondary endpoints included: target lesion revascularisation (tlr), target lesion failure (tlf, a composite of cardiac death, any mi not clearly attributable to a non-target vessel, or clinically driven tlr), major adverse cardiac events (mace, a composite of all-cause death, any mi, or emergent coronary bypass surgery, or repeat clinically indicated tlr), the most global patient-oriented composite endpoint (poce, a composite of all-cause death, any mi, or any repeat coronary revascularisation), and definite-or-probable stent thrombosis.During follow-up, clinical events reported in patients treated with resolute integrity zes were death, myocardial infarction, revascularization and stent thrombosis.

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: 7684713
• MDR Text Key: 113868299
• Report Number: 9612164-2018-01717
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• 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: 08/08/2018
• 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): Death
• Patient Age: 64 YR