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

Device Problems Activation, Positioning or SeparationProblem (2906); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2021

Event Type  malfunction  

Event Description

A journal article was submitted for review titled: one-year outcome of single-stent crossover versus accurate ostial stenting for isolated left anterior descending ostial stenosis. The aim of this study was to investigate the clinical outcomes of patients with left anterior descending artery (lad) ostial stenosis treated by single-stent crossover or accurate ostial stenting. A total of 216 eligible patients with isolated de novo lad ostial stenosis were enrolled in the study, of which 78 of these patients were included in the single-stent crossover technique group and 138 patients were included in the accurate ostial stenting technique group. The study endpoint was defined as a composite rate of major adverse cardiac events (mace) including cardiac death, myocardial infarction, non-fatal stroke and target vessel revascularization (tvr). Coronary angiography and percutaneous coronary intervention (pci) were performed with standard techniques via the femoral or radial approach. Resolute integrity drug eluting stents were among the stents used pci procedures. Accurate ostial stenting was used when there was a large difference in vessel diameters between left main coronary artery (lmca) and lad or existence of left circumflex artery (lcx) ostial lesion. The single-stent crossover technique was used when the angle between lad and lcx was small. For accurate ostial stenting, the stent was positioned with traditional angiographic guidance or by using the szabo method. Single-stent crossover procedures included pre-dilation of lad with a non-compliant balloon, use of a stent with its diameter similar to distal lad reference vessel, placement of a stent around 6¿8 mm back into the lmca with complete coverage of the lcx ostium, use of proximal optimization technique (pot) when there is a greater difference between the lmca and proximal lad diameters and balloon kissing only when lcx presented thrombolysis in myocardial infarction (timi) flow <(><<)>2 or residual ostial stenosis >70%. During the follow up, no all cause death or cardiac death occurred. Myocardial infarction, stroke, target vessel revascularization (tvr) and target lesion revascularization (tlr) were reported from both groups. In the accurate ostial stenting group, the tlr was due to in-segment restenosis as a result of incomplete coverage of the lesions by a stent at its proximal end in 11 patients which caused the development of a new lmca lesion which eventually triggered an asymmetric protrusion of the stent struts in two patients and resulted from significant deformation of the stent by anchoring side branch guidewire using the sazbo technique in one patient.

Manufacturer Narrative

Journal article: one-year outcome of single-stent crossover versus accurate ostial stenting for isolated left anterior descending ostial stenosis authors: zhen kun yanga, jian hua, feng hua dinga, jing wei nia, rui yan zhanga and wei feng shena journal: coronary artery disease year: 2022 reference: doi: 10. 1097/mca. 0000000000001071. Average age. Majority gender. Date of publication. If information is provided in the future, a supplemental report will be issued.

• 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: 13965413
• MDR Text Key: 289457256
• Report Number: 9612164-2022-01261
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/31/2022 Patient Sequence Number: 1