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

Lot Number UNKNOWN

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Thrombus (2101); Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: dapt - clopidogrel and aspirin.Ticgrelor and prasugrel.(b)(4).Journal article: randomized all-comers evaluation of a permanent polymer zotarolimus-eluting stent versus a polymer-free amphilimus-eluting stent.Title: journal: american heart association, inc year: 2019 ref: doi: 10.1161/circulationaha.118.037707.Age or 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

This study investigates the clinical safety and efficacy of polymer-free amphilimus-eluting stents( pf-aes) as compared with latest generation permanent-polymer zotarolimus-eluting stents (pp-zes).Between nov 3, 2014 and july 10, 2017, 1502 eligible all-comers patients with 2133 lesions, aged 29 to 93 years, consented to study enrollment.Pp-zes used were resolute integrity drug eluting stents.Pf-aes used were non medtronic stents.Lesions treated with resolute integrity included left main, left anterior descending artery, left circumflex artery, right coronary artery, arterial bypass graft, venous bypass graft.Clinical outcomes reported included death , cardiac death, myocardial infarction, stent thrombosis, revascularization, stroke and major bleeding.

• 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: 8538694
• MDR Text Key: 142735830
• Report Number: 9612164-2019-01435
• 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
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2019
• 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: 65 YR