MAUDE Adverse Event Report: MEDTRONIC, INC EXPORT AP ASPIRATION CATHETER; CATHETER, EMBOLECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Fistula (1862); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Perforation (2001); Tachycardia (2095); Ventricular Fibrillation (2130); Vascular Dissection (3160); Heart Failure/Congestive Heart Failure (4446)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: average age.Gender = majority gender.Date of event =date of publication authors: bekir s.Yildiz, nurullah cetin, ramazan gunduz, adnan bilge, su ozgur, mehmet n.Orman journal name: sage journals year: 2022 title of article: effect of coronary thrombus aspiration in non st elevation acute coronary syndrome patients on three-year survival- does it add any benefit? literature reference: doi: 10.1177/00033197211053404 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 ¿effect of coronary thrombus aspiration in non st elevation acute coronary syndrome patients on three-year survival- does it add any benefit¿.The study assessed the effect of thrombus aspiration (ta) during percutaneous coronary intervention (pci) on in-hospital and 3-year mortality in consecutive non-st segment elevation myocardial infarction (n = 189) and unstable angina pectoris (n = 148) patients (n = 337) between 2011 and 2016.In total, 153 patients (45.4%) underwent ta.A 6f export aspiration catheter, a 6f compatible ta catheter with an aspiration lumen of.041 inch and cross profile of.068 inch, which was handled over a guide wire of.014 inch in a monorail fashion were used in the ta procedures.The export catheter was carefully advanced through the target lesion during continuous aspiration after placement of the guide wire.Suction was performed by hand with lockable 20 ml syringes.Manual ta was performed during catheterisation by experienced interventional cardiologists based on the suspicion of lesion-site thrombus formation with or without impaired baseline coronary flow.Lesions treated were in the lmca, cx, lad and rca.Non-medtronic des were implanted.Procedural complications included coronary dissection, coronary perforation, hematoma and arteriovenous fistula.At three year follow up clinical outcomes included; death, stroke, stent thrombosis, major bleeding, recurrent- mi, atrial fibrillation, ventricular tachycardia, ventricular fibrillation, rehospitalization for heart failure and new cabg.Thrombus aspiration was associated with a significant improvement both in epicardial flow, myocardial perfusion and left ventricular ejection fraction.Thrombus aspiration during pci in all acute coronary syndrome (except st segment elevation) patients was associated with better survival compared with stand alone pci group at 3-year follow-up.

• Brand Name: EXPORT AP ASPIRATION CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15622988
• MDR Text Key: 301916831
• Report Number: 1220452-2022-00075
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K040869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/18/2022
• 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): Other
• Patient Age: 63 YR
• Patient Sex: Male