MAUDE Adverse Event Report: MEDTRONIC IRELAND TELESCOPE GUIDE EXTENSION CATHETER; CATHETER, PERCUTANEOUS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/21/2022

Event Type  Injury  

Manufacturer Narrative

Title: dual role of guide extension catheters for the management of high thrombus burden in stemi: case report and mini review authors: juan i.Damonte, alejandro d.Fernández, carla r.Agatiello, ignacio m.Seropian.Journal name: cardiovascular revascularization medicine year: 2022.Reference: doi.Org/10.1016/j.Carrev.2022.07.008.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.

Event Description

A journal article was submitted for review titled "dual role of guide extension catheters for the management of high thrombus burden in stemi: case report and mini review".This article reviewed current strategies for high thrombus burden and a case report was presented with the combination of two different techniques: aspiration through a guide extension catheter followed by local intracoronary thrombolysis with ¿marinade¿ technique.A patient with no relevant past medical history presented to the emergency department with general discomfort and asthenia lasting 24 hours.The patient was hemodynamically unstable, with a low blood pressure, high irregular heart rhythm, skin was cold and the patient was disoriented.Electrocardiography showed a rapid response atrial fibrillation rhythm with st-segment elevation in the anterior leads.The emergency department team proceeded with intubation and tried electrical cardioversion with no success.Aspirin and clopidogrel was administered through nasogastric tube and patient was urgently taken to the catheterization laboratory.Coronary angiography (cag) was performed through right femoral access (6-french) and showed a complete occlusion of the left anterior descending artery (lad) near the ostium with timi 0 flow and large amount of thrombus (timi thrombus grade 5).During the percutaneous coronary intervention (pci) unfractioned heparin was given to the patient and a mechanical thrombectomy with a 2.5 x 15 mm semi compliant non-medtronic (mdt) balloon was performed without improvement in timi flow.Due to thrombus organization, a regular 0.014 thrombus aspiration catheter was considered small and not used.Instead, a 6f telescope guide extension catheter (gec) was advanced to the place of occlusion.The hemostatic valve was disconnected from the manifold and a luer-lock 10 ml syringe was attached to the side port of the valve.Manual aspiration was performed until the syringe was filled.The retrieved material showed a large red organized thrombus.Timi 2¿3 flow was restored, but a large filling defect persisted in the proximal portion of the lad despite another passage of aspiration through the gec, suggestive of wall-adherent thrombus.Therefore, catheter-directed intracoronary thrombolysis with ¿marinade¿ technique was performed.The telescope gec was advanced again to the place of thrombus and a 2.5 x 15 mm non-mdt balloon was inflated distal to the thrombus at the level of a large diagonal branch.Subsequently, alteplase was slowly infused while maintaining the inflated balloon in the diagonal branch during 3 minutes.Following balloon deflation, the filling defect disappeared and timi 3 flow persisted with no signs of distal embolization.Finally, a 3.5 x 20mm non-mdt drug eluting stent was placed in the ostial/proximal lad with good final result without any flow disturbance and no distal embolization.

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: TELESCOPE GUIDE EXTENSION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 16334652
• MDR Text Key: 309146004
• Report Number: 9612164-2023-00587
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K183353
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• 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: 02/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female