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

Model Number UNK-CV-DAN-EXP-AP

Device Problems Suction Problem (2170); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Stenosis (2263); Injury (2348)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The article 'failed primary percutaneous coronary intervention in a middle-aged man without cardiovascular risk factors: left atrium myxoma' was submitted.This article details the case of a single patient who was referred to the emergency department with typical angina.Medtronic export ap aspiration catheter was among the devices used an electrocardiogram (ecg) undertaken showed hyper acute st elevation in anterolateral and inferior leads.A primary percutaneous coronary intervention (pci) procedure was performed.Coronary angiography revealed that the patients left anterior descending artery (lad) was occluded at the far mid portion.After wiring the vessel with some difficulties due to the thrombotic manifestation of the lesion, an export ap aspiration catheter was then used to perform thrombosuction.This was unsuccessful and several efforts at balloon inflation using a non-medtronic balloon were made but these attempts also proved to be unsuccessful with the thrombolysis in myocardial infarction flow grade (timi) noted to be 0-1.The procedure was terminated and the patient was admitted to cardiac care unit (ccu).The chest pain resolved 5 hours later and the patient was both hemodynamically and electrically stable.The following day after admission, echocardiography showed left ventricle ejection fraction (lvef) to be 45% with some regional wall motion abnormalities noted in the lad territory.A large homogenous la mass (3.5 × 3.5cm) attached to inter atrial septum that protruded to mitral valve inflow was also observed.It was therefore decided to manage the patient surgically in an urgent setting in order to prevent repeated embolization.A large pedunculate mass, originating from left atrial septum, covered with fresh clot was resected.A pathologic study showed a brown mucoid tissue which was compatible with cardiac myxoma.The patient reportedly had a normal post-operative period and was discharged after 5 days.

Manufacturer Narrative

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: EXPORT AP ASPIRATION CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 10470339
• MDR Text Key: 219176275
• Report Number: 1220452-2020-00071
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: K120808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

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
• Device Model Number: UNK-CV-DAN-EXP-AP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR