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 Chest Pain (1776); Nausea (1970); Thrombus (2101); Stenosis (2263)

Event Date 03/28/2020

Event Type  Injury  

Manufacturer Narrative

Journal article: percutaneous coronary intervention following fontan procedure authors: ahmed subahi, thomas forbes, omar e.Ali journal: ijc heart <(>&<)> vasculature year: 2020 reference: https://doi.Org/10.1016/j.Ijcha.2020.100511 b3: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A case report was submitted.Patient presented with onset acute chest pain.Ecg confirmed a new v2 to v4 st-segment depression.Coronary angiogram showed complete occlusion of the proximal left circumflex coronary artery (lcx) by thrombus embolization.Serial aspiration thrombectomy was performed using an export ap aspiration catheter.However, due to a small residual thrombus, balloon angioplasty was also performed.Postangioplasty angiography showed complete thrombus resolution, and the left circumflex flow improved significantly.Patient was transferred to the intensive care unit (icu) on aspirin, clopidogrel, and heparin drip in stable condition.Approximately 24 hours later, the patient continued to complain of chest pain and nausea.Ecg confirmed lateral v5 and v6 st-segment elevation.Trans-thoracic echocardiography showed new deterioration in the right ventricular systolic function, with apical, and interventricular septum hypokinesia.Significant clot burden in the left anterior descending (lad) and lcx was found.Mechanical aspiration thrombectomy was performed in the lad and lcx using a non-medtronic device.A local injection of nitroglycerin was administered.Significant stenosis that wasn't present at initial catheterization was noted in the proximal lcx.There was no evidence of dissection.It was stated that the persistent stenosis seen in the proximal lcx could be related to residual thrombus or post-angioplasty trauma on the vessel wall that may be produced a hematoma of the vessel wall or a subacute recoil of the vessel.Due to the persistent stenosis and high risk of re-occlusion of the lcx a 2.5x15 mm resolute onyx drug eluting stent was implanted in the proximal lcx.Final angiography showed significant improvement of flow in the lcx.Final angiography showed significant improvement of flow in the lcx.Overnight the patients symptoms completely resolved.Seven days after the second procedure, there was a significant improvement in cardiac function.The patient was discharged.

• 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: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10217101
• MDR Text Key: 197164278
• Report Number: 1220452-2020-00052
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2020

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
• Initial Date Manufacturer Received: 06/21/2020
• Initial Date FDA Received: 07/01/2020
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 10 YR