FDA Adverse Event Death Summary report: N

RESOLUTE INTEGRITY RX

MDR report key: 8538653 · Received April 23, 2019

Report

Report Number: 9612164-2019-01434
Event Type: Death
Date Received: April 23, 2019
Date of Event: September 19, 2018
Report Date: April 23, 2019
Manufacturer: MEDTRONIC IRELAND
Product Code: NIQ
PMA / PMN Number: P110013
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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. AVERAGE AGE, MAJORITY GENDER. DATE OF PUBLICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
331735	RESOLUTE INTEGRITY RX	STENT, CORONARY, DRUG-ELUTING	NIQ	MEDTRONIC IRELAND		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Death\| R