MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER® CRIBRIFORM OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Device Problems Biocompatibility (2886); Human-Device Interface Problem (2949)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/19/2021

Event Type  malfunction  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that on (b)(6) 2021, an amplatzer cribriform occluder was successfully implanted in aortic root of the patient.Patient co-morbidities include a left ventricular assist device (lvad), heart failure with reduced ejection fraction, left ventricular assist device (lvad) complicated by aortic insufficiency (ai), aortic thrombus, chronic kidney disease (ckd), chronic obstructive pulmonary disease (copd), hypertension (htn), obstructive sleep apnea (osa), transient ischemic attack (tia), atrial fibrillation, chronic respiratory failure.On (b)(6) 2021, the patient presented into the emergency room due to concern for possible lvad occlusion.Patient's lactate dehydrogenase (ldh) level was 1065 (u/l), prothrombin time was 25.9 seconds, and haptoglobin level was less than 30mg/dl.On electrocardiogram (ecg) patient was tachycardic.On (b)(6) 2021, a ct scan was performed on the patient chest lvad which showed a right ventricle (rv) and right atrium (ra) thrombus but no lvad thrombus.On (b)(6) 2021 the patient then underwent a transesophageal echocardiogram (tee) and mild eccentric peri-device leak was noted with the cribriform occluder.It was thought that this was likely the cause of the elevated ldh.A large echodense structure was seen in what it looked like the aortic lumen.When compared with ct there is no evidence of thrombus in the entire aorta and the structure likely represents lung tissue coming into plane, although a large aortic thrombus could not be fully excluded.No aortic insufficiency.There was no pericardial effusion.The patient required serial ldh and complete blood count (cbc) during outpatient with possible transfusions if necessary but there are no plans for further intervention.No medication changes were made.No additional information was provided.

Manufacturer Narrative

An event of thrombus and leak around the device was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Clinical study (b)(6), patient id: (b)(6).It was reported that on (b)(6) 2021, an amplatzer cribriform occluder was successfully implanted in aortic root of the patient.Patient co-morbidities include a left ventricular assist device (lvad), heart failure with reduced ejection fraction, left ventricular assist device (lvad) complicated by aortic insufficiency (ai), aortic thrombus, chronic kidney disease (ckd), chronic obstructive pulmonary disease (copd), hypertension (htn), obstructive sleep apnea (osa), transient ischemic attack (tia), atrial fibrillation, chronic respiratory failure.On (b)(6) 2021, the patient presented into the emergency room due to concern for possible lvad occlusion.Patient's lactate dehydrogenase (ldh) level was 1065 (u/l), prothrombin time was 25.9 seconds, and haptoglobin level was less than 30mg/dl.On electrocardiogram (ecg) patient was tachycardic.On (b)(6) 2021, a ct scan was performed on the patient chest lvad which showed a right ventricle (rv) and right atrium (ra) thrombus but no lvad thrombus.On (b)(6) 2021 the patient then underwent a transesophageal echocardiogram (tee) and mild eccentric peri-device leak was noted with the cribriform occluder.It was thought that this was likely the cause of the elevated ldh.A large echodense structure was seen in what it looked like the aortic lumen.When compared with ct there is no evidence of thrombus in the entire aorta and the structure likely represents lung tissue coming into plane, although a large aortic thrombus could not be fully excluded.No aortic insufficiency.There was no pericardial effusion.The patient required serial ldh and complete blood count (cbc) during outpatient with possible transfusions if necessary but there are no plans for further intervention.No medication changes were made.No additional information was provided.

• Brand Name: AMPLATZER® CRIBRIFORM OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12790464
• MDR Text Key: 281599432
• Report Number: 2135147-2021-00490
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American