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

Device Problems Activation, Positioning or Separation Problem (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.

Manufacturer Narrative

Additional information: annex d code added medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 05/16/2022
• 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