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

Catalog Number UNK AMPLATZER SEPTAL OCCLUDER

Device Problem Off-Label Use (1494)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Liver Damage/Dysfunction (1954); Pneumonia (2011); Heart Failure/Congestive Heart Failure (4446)

Event Date 08/07/2023

Event Type  Death  

Manufacturer Narrative

B2 - date of death is estimated.B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effects reported in the articles are captured under a separate medwatch report.Summarized patient outcomes/complications of infarct exclusion repair of post-myocardial infarction ventricular septal rupture with a hybrid patch and septal occluder device compared to patch only were reported in a research article in a subject population with multiple co-morbidities including hypertension, diabetes, coronary artery disease, previous coronary artery bypass graft, prior percutaneous coronary intervention, acute renal failure, cardiogenic shock, preoperative intra-aortic balloon pump.Some of the complications reported were low cardiac output (co) syndrome (heart failure), atrial fibrillation, pacemaker, dialysis, stroke, pneumonia, liver failure, bleeding, surgical intervention, death these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Please note, per the instructions for use, "the amplatzer septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for occlusion of atrial septal defects (asds) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration.".

Event Description

The article, ¿infarct exclusion repair of post-myocardial infarction ventricular septal rupture with a hybrid patch and septal occluder device compared to patch only¿, was reviewed.The article presented a retrospective single center study to compare outcomes of patients with post-mi vsd repaired using patch only or hybrid patch/sod.The device mentioned in the article is amplatzer septal occluder.The article concluded post-mi vsd repair with patch/sod has comparable short-term outcomes to patch alone.Addition of a sod to patch repair provides a scaffold that may enhance the repair of post-mi vsd with patch exclusion.[the primary and corresponding author is adam williams, duke university, 2301 erwin road, durham nc 27701, with corresponding email: arw55@duke.Edu].

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17653706
• MDR Text Key: 322322218
• Report Number: 2135147-2023-03781
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER SEPTAL OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• 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 Outcome(s): Death