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

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

Patient Problems Myocardial Infarction (1969); Unspecified Tissue Injury (4559)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: clinical outcome after percutaneous coronary intervention with drug-eluting stent in bifurcation and nonbifurcation lesions: a meta-analysis of 23981 patients authors: burzotta, francesco; annone, umberto; paraggio, lazzaro; d'ascenzo, fabrizio; biondi-zoccai, giuseppe; aurigemma, cristina; romagnoli, enrico; verdirosi, diana; trani, carlo; crea, filippo journal: coronary artery disease year: 2020 reference: doi:10.1097/mca.0000000000000847 patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the death(s) was provided age: average age.Sex: majority gender.Date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - clinical outcome after percutaneous coronary intervention with drug-eluting stent in bifurcation and nonbifurcation lesions: a meta-analysis of 23 981 patients - was submitted.A systematic literature search was performed to identify studies reporting the clinical outcome of patients undergoing percutaneous coronary intervention (pci) in coronary bifurcation lesions (cbl) and 15 publications on 23891 patients with were identified.The primary study endpoint was major adverse cardiac events (mace).The mace events identified were death, tvr and mi.Resolute integrity des was used in four of the studies identified which categorized patients into cbl and non cbl groups.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12420024
• MDR Text Key: 269742165
• Report Number: 9612164-2021-03416
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• 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: 08/25/2021
• 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: 64 YR