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 Problem Obstruction/Occlusion (2422)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

Summarized patient outcomes/complications of amplatzer septal occluder were reported in a research article in a subject population with multiple co-morbidities including patent ductus arteriosus (including types a, b, c ¿ tubular, d, and e).Some of the complications reported was obstruction/occlusion; this complication is 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.Per the instructions for use, (b)(6), revision a, stated "indication and usage: the amplatzer¿ septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the 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.Patients indicated for asd closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular (rv) volume overload (ie, 1.5:1 degree of left-to-right shunt or rv enlargement).".

Event Description

The article, ¿tubular pda versus other pda types: challenging device choice for transcatheter closure¿, was reviewed.The article presented a retrospective multi- center study to assess the safety and effectiveness of different devices for transcatheter closure of tubular patent ductus arteriosus (pda).Devices included in this study were cook detachable coil, nit-occlud coil, amplatzer duct occluder (ado i and ado ii), amplatzer vascular plug ii (avp ii), amplatzer muscular vsd occluder (mvsd), and amplatzer septal occluder (aso).The article concluded different devices can be used successfully to close tubular pdas in infants and children.Avp ii may be a reasonable option in cases with a relatively narrow diameter.[(b)(6)].

• 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: 17905008
• MDR Text Key: 325341757
• Report Number: 2135147-2023-04414
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER SEPTAL OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/10/2023
• 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): Other