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 Stroke/CVA (1770); Myocardial Infarction (1969)

Event Date 03/08/2022

Event Type  Injury  

Manufacturer Narrative

Authors: philippe généreux, gil chernin, abid r.Assali, jan z.Peruga, simon d.Robinson, erick schampaert, rodrigo bagur, samer mansour, josep rodés-cab journal name: american heart journal year: 2022 title of article: double-blind, placebo-controlled evaluation of biorest liposomal alendronate in diabetic patients undergoing pci: the blade-pci trial literature reference: doi.Org/10.1016/j.Ahj.2022.03.004.Age: average age; gender: majority gender; event ate: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted for review titled: double-blind, placebo-controlled evaluation of biorest liposomal alendronate in diabetic patients undergoing pci: the blade-pci trial.The aim of the biorest liposomal alendronate administration for diabetic patients undergoing drug-eluting stent percutaneous coronary intervention (blade-pci) trial was to assess the safety, effectiveness, and dose response of labr-312 administered intravenously at the time of pci with drug-eluting stents (des) in reducing restenosis as measured by optical coherence tomography (oct) at 9 months post procedure in patients with diabetes.A total of 136 patients were randomized to labr-312 infusion and 135 patients were randomized to the placebo group.In both study arms, all target lesions were treated with resolute integrity drug eluting stents (des) during the index pci.Lesions treated included non, mild, moderate and severely calcified lesions, non, mild, moderate and severely tortuous lesions in the left anterior descending coronary artery (lad) and right coronary artery (rca).The primary efficacy endpoint was the 9-month in stent percent neointimal hyperplasia (nih) volume.Secondary endpoints included oct-derived minimal lumen area, percent nih at minimal lumen area sites, percent area stenosis, and percent stent strut coverage.Secondary angiographic endpoints included in-stent late loss, percent diameter stenosis, and binary restenosis.Clinical endpoints included major adverse cardiac events defined as death, myocardial infarction, or clinically driven target lesion revascularization at 30 days and 9 months.The safety of the resolute integrity des platform was evident in the study, with no stent thromboses or deaths observed in the entire study population through 9-month follow-up.In stent restenosis, stroke, myocardial infarction, target vessel revascularization (tvr), target lesion revascularization (tlr), target vessel failure, target lesion failure were reported from this study.

• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15110597
• MDR Text Key: 296659857
• Report Number: 9612164-2022-02819
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 07/21/2022
• 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
• Patient Sex: Male