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

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/14/2021

Event Type  Injury  

Event Description

A journal article was submitted for review titled: in vivo evidence of atherosclerotic plaque erosion and healing in patients with acute coronary syndrome using serial optical coherence tomography imaging.The aim of the study was to investigate the incidence of newly formed healed plaque and different baseline characteristics of acute coronary syndrome (acs) patients caused by plaque erosion with or without newly formed healed plaque using optical coherence tomography (oct).Lesions treated included the left anterior descending artery (lad), left circumflex artery (lcx) and the right coronary artery (rca).Some lesions had multi-vessel disease and manual thrombectomies were required in some cases.Manual aspiration thrombectomy procedures were performed using an export catheter.A total of 137 acs patients with culprit plaque erosion who underwent pre-intervention oct imaging and received no stent implantation were enrolled.137 patients were reexamined with angiography and oct at 1-month follow-up and 52 patients were reexamined angiography and oct at 1-year follow-up.Patients were divided into different groups according to the presence or absence of newly formed healed plaque.During the 1 month oct follow-up 76 patients were in the group "patients with newly formed healed plaque" and 61 patients were in the group "patients without newly formed healed plaque".In the 1 year follow-up 36 patients were in the group "patients with newly formed healed plaque" and 16 patients were in the group "patients without newly formed healed plaque".Red and white thrombus were reported in both groups of patients at 1 month oct follow-up.There was incidents of ischemia-driven rev ascularization and stenosis reported in this study.Among 137 patients completed 1-month oct follow-up, 79 (57.7%) patients had healed plaque at baseline; 76 (55.5%) patients developed typical healed plaque; and 44 (32.1%) patients had healed plaque at baseline and newly formed healed plaque.In 52 patients completed 1-year oct follow-up, 22 (42.3%) patients had healed plaque at baseline; 36 (69.2%) patients developed typical healed plaque; 17 (32.7%) patients had healed plaque at baseline and newly formed healed plaque.Compared with patients without newly formed healed plaque, patients with newly formed healed plaque had smaller lipid arc, lower degree of percentage of area stenosis (as%), longer thrombus length, greater thrombus area, thrombus volume and thrombus burden.

Manufacturer Narrative

Journal article: in vivo evidence of atherosclerotic plaque erosion and healing in patients with acute coronary syndrome using serial optical coherence tomography imaging authors:yanwei yin, chao fang, senqing jiang, jifei wang, yidan wang, junchen guo, fangmeng lei, sibo sun, xueying pei, ruyi jia, lulu li, yini wang, huai yu, jiannan dai, bo yu journal: american heart journal year: 2022 reference: doi: 10.1016/j.Ahj.2021.09.007.Average age.Majority gender.Date of publication.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXPORT UNKNOWN
• 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: 14641126
• MDR Text Key: 293654039
• Report Number: 1220452-2022-00042
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152335
• 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: 06/09/2022

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/09/2022
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male