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

Model Number RSINT25018X

Device Problem Fracture (1260)

Patient Problems Myocardial Infarction (1969); Insufficient Information (4580)

Event Date 11/16/2022

Event Type  Injury  

Event Description

A journal article was submitted for review titled "coronary stent fracture causing myocardial infarction: case report and review of literature".In this review, two cases of stent fractures (sf) are described, followed by an analysis of current literature on the pathomechanism, diagnostic tools, classification and therapeutic management of coronary stent fractures.Patient 2 had undergone a coronary artery bypass graft (cabg) surgery with use of the left internal mammary artery (lima) more than 20 years prior to the index admission.With progression of the coronary artery disease, 3 non-medtronic (mdt) everolimus-eluting stents (ees) had been implanted via the native left main artery (lm) in the left anterior descending artery (lad) segments 5, 6 and 7.One of the respective ees (3.0 × 16 mm) had been deployed at a high-grade de-novo stenosis of the inserting region of the lima-ad-lad-bypass in segment 7.After a good short-term result, 6 months later an increase of exercise induced dyspnea had occurred.Coronary angiogram (cag) had again been performed showing in stent restenosis (isr) of the lima-ad-lad inserting region and a non-mdt paclitaxel-coated-balloon had been applied, accessing via the lm.Eighteen months later, the patient had again presented with unstable angina pectoris.Cag had shown recurrent isr in segment 7 and a non-mdt 2.5 × 20 mm ees had been implanted, again using the lm as access.One month later, the patient had been re-admitted due to angina pectoris.Cag had shown a gap within the previously implanted drug e luting stent (des) in the insertion region of the lima-ad-lad-bypass, suggesting type iv sf.Repeat percutaneous coronary intervention (pci) and deployment of two 2.5 × 18 mm resolute integrity zotarolimus eluting stent (zes) was performed via the lm to stabilize the fracture.At the latest admission, only weeks later, the patient presented with non-st-elevation myocardial infarction (nstemi).The patient was transferred to cag and re-sf of the medial lad (type iv) with distal timi-0-flow and prominent hinge motion was found.Catheterization of the fracture using a a non-mdt guidewire through the lm was unsuccessful.Further attempts of pci were not carried out.The patient was commenced with dual antiplatelet therapy.

Manufacturer Narrative

Matthias gröger, wolfgang rottbauer, and mirjam kessler."coronary stent fracture causing myocardial infarction: case report and review of literature".Reviews in cardiovascular medicine, no.11, 2022, https://doi.Org/10.31083/j.Rcm2311384.B3: date of publication 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.

Manufacturer Narrative

Additional information: annex d code.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: 17884610
• MDR Text Key: 325064150
• Report Number: 9612164-2023-04514
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSINT25018X
• Device Catalogue Number: RSINT25018X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• 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: 73 YR
• Patient Sex: Male