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); Congestive Heart Failure (1783); Myocardial Infarction (1969); Injury (2348); Blood Loss (2597)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Impact of left ventricular hypertrophy on long-term clinical outcomes in hypertensive patients who underwent successful percutaneous coronary intervention with drug-eluting stents doi: 10.1097/md.0000000000012067.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 investigated 8-year clinical outcomes of hypertensive patients with left ventricular hypertrophy (lvh) who underwent percutaneous coronary intervention (pci) with drug-eluting stents (des) compared with hypertensive patients without lvh among device used were resolute integrity rx drug eluting stents to treat lesion located in the left main, left anterior descending , right coronary artery, circumflex and ramus.A total of 1704 consecutive hypertensive patients who underwent pci from 2004 to 2014 were enrolled cumulative clinical outcomes up to 8 years included gastrointestinal bleeding, congestive heart failure, all cause death(including deaths due to stemi, non-stemi, sudden cardiac death and heart failure), fatal and non-fatal myocardial infarction, cerebrovascular accident and tvr.

• 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: 8799062
• MDR Text Key: 151328388
• Report Number: 9612164-2019-02917
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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: 06/17/2019
• 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
• Treatment: ASPIRIN, CLOPIDOGREL
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR