MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER (UNKNOWN); TRANSCATHETER SEPTAL OCCLUDER

Device Problem Off-Label Use (1494)

Patient Problems Atrial Flutter (1730); Tachycardia (2095); Pericardial Effusion (3271); Heart Block (4444)

Event Type  Injury  

Manufacturer Narrative

In an research article, one ventricular tachycardia managed with cardioversion, one atrial flutter managed with cardioversion one transient complete heart block, transient shunts and one mild pericardial effusion with spontaneous resolve were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the pda duct occluder instructions for use, arten600038221- a "indications and usage: the amplatzer¿ duct occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (pda).".

Event Description

Related manufacturing reference number: 2135147-2021-00434.The article, "transcatheter closure of residual and iatrogenic ventricular septal defects: tertiary center experience and outcome" was reviewed.This research article is a retrospective single center experience to assess long term outcome of transcatheter closure of post-surgical and post-intervention residual and iatrogenic ventricular septal defects (vsds).Amplatzer muscular vsd occluder, amplatzer duct occluder and amplatzer duct occluder ii were associated with the study.The article concluded that transcatheter closure of post-operative and post-intervention residual/iatrogenic vsds represents a safe, feasible, and effective therapeutic approach.The primary and correspondence author of the article is fatma a.Taha, adult cardiology department, madinah cardiac center, khaled bin waleed road, madinah 6167, saudi arabia with the corresponding email: fatmastaha@yahoo.Com.

• Brand Name: AMPLATZER DUCT OCCLUDER (UNKNOWN)
• 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: 12705035
• MDR Text Key: 278603703
• Report Number: 2135147-2021-00435
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/27/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Weight: 36