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

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problems Cardiac Arrest (1762); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Insufficient Information (4580)

Event Date 10/20/2022

Event Type  Injury  

Event Description

A journal article was submitted for review titled "accordion-like stent deformation caused by entrapped guidewire: a case report".The patient was admitted to the intensive care unit with ongoing chest pain lasting for 90 minutes, with clinical signs of cardiogenic shock.At the admission, the patient was alert, responsive, orientated, hypotensive, with bilateral diffuse pulmonary crepitations and pale, wet skin.An electrocardiogram (ecg) was performed which showed showed upsloping st depression at j point, with positive t wave in inferior leads and complete atrioventricular block.Two dimensional transthoracic echocardiography (tte) revealed increased thickness of left ventricular walls with hypokinetic posterolateral segments, reduced ejection fraction, estimated of 44% and without significant valvular pathology.Baseline laboratory tests showed elevated values of cardiac biomarkers.Based on the symptoms, clinical signs, ecg and echocardiography findings, the patient was diagnosed with a st-elevation myocardial infarction (stemi).The decision was made to perform an urgent coronary angiography.Coronary angiography revealed significant stenosis of circumflex coronary artery bifurcation (rcx) which was the culprit lesion.There was also significant narrowing of the second obtuse marginal branch (om) - 75% and left anterior descending artery (lad) - 90%.No significant stenosis of the right coronary artery (rca) and its branches was found.During the percutaneous coronary intervention (pci) a 3.0 x 16mm non mdt drug eluting stent (des) was implantedin the om.During the second des implantation of a 3.5 x 28 mm resolute onyx des in the om, a cardiac arrest occurred.It was also stated that the resolute onyx stent was not fully expanded due to the aggravated circumstances and during manual compression of the thoracic wall a guidewire loop was made.Cardiopulmonary resuscitation was performed and spontaneous circulation was restored (rosc).After achieving rosc, the stent was immediately implanted and it was not noticed that guidewire looped-tip was entrapped/jailed between the two stents.All attempts to pull out entrapped wire caused longitudinal, accordion-like stent deformation.Advancing a small over-the-wire (otw) balloon to the jailed segment of the wire, a narrow space between the deformed stent and vessel wall was created after balloon inflation, causing the wire to untangle and the jailed guide wire was successfully retrieved with the small otw balloon.Stent deformation caused an intimal injury of om.One more 3.0 x 12 mm non mdt des was implanted in rcx overlapping the first-implanted stent.The procedure was followed by implantation of a non mdt 2.75 x 33 mm des in the distal rcx using t and small protrusion (tap) technique.Timi 3 was achieved in both distal rcx and om.The patient was transferred to the intensive care unit for further monitoring and management.Ten days after the primary pci, the patient underwent re-coronarography and optical coherent tomography (oct) which detected accordion-like deformed stent in om, with estimated minimal lumen area (mla) of 2mm^2 right below the bifurcation.Plaque erosion with thrombus masses were also note below the stent, followed by well expanded and apposed stents distally.Additionally, severe iatrogenic dissection was noted proximally to the deformed stent.An oct guided 3.5 x 38 mm resolute onyx des implantation was performed, using proximal optimization and kissing technique.Optimal expansion and stent apposition were confirmed by oct.Furthermore, oct 3d reconstruction allowed detailed analysis, registering that previously implanted stent was crushed underneath the last implanted stent.The patient was discharged on the 12th day after the admission in a stable clinical condition.During the annual follow-up, there were no adverse events observed.

Manufacturer Narrative

Title: accordion-like stent deformation caused by entrapped guidewire: a case report.Authors: milenko cankovic, vanja drljevic todic, milovan petrovic, vladimir ivanovic, mila kovacevic, aleksandra milovancev, marija bjelobrk, tatjana miljkovic, mirko todic journal name: acta medica mediterranea year: 2023 reference: doi: 10.19193/0393-6384_2023_2_52 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 ONYX 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: 17172789
• MDR Text Key: 317636785
• Report Number: 9612164-2023-02757
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• 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: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female