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

Device Problems Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949)

Patient Problems Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Pericardial Effusion (3271); Foreign Body Embolism (4439); Pulmonary Hypertension (4460)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a total of 332 patients underwent transcatheter pda closure between january 2002 and september 2019; amplatzer duct occluder, amplatzer duct occluder ii, amplatzer duct occluder ii additional sizes, amplatzer vascular plug ii, amplatzer muscular vsd occluder, cook detachable coils, boston scientific pushable coils, nit-occlud pda coils and nit-occlude pda-r devices were associated with the study.It was reported that 139 patients were implanted with a type of amplatzer duct occluder.Events of device embolization, aortic arch obstruction, left pulmonary artery (lpa) obstruction, residual shunt, pericardial effusion with spontaneous resolve, transient thrombosis, pulmonary hypertensive crisis, pseudoaneurysm, prolong bleed and re-interventions 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.

Event Description

Related manufacturing reference number: 2135147-2021-00403, 2135147-2021-00404.The article, "immediate and long-term results of transcatheter closure of patent ductus arteriosus-comparison of two decades before and after change in antibiotic infective endocarditis prophylaxis guidelines", was reviewed this research article is an observational single center study to review the types of patent ductus arteriosus (pda) closed, the devices used, success rates, immediate or postprocedural adverse events (ae) and the overall changing pattern of the procedure by comparing two time periods before and after changes in ap guidelines in 2009.Amplatzer duct occluder, amplatzer duct occluder ii, amplatzer duct occluder ii additional sizes, amplatzer vascular plug ii, amplatzer muscular vsd occluder, cook detachable coils, boston scientific pushable coils, nit-occlud pda coils and nit-occlude pda-r devices were associated with the study.The article concluded that transcatheter pda closure is an efficient and safe procedure with high complete closure rate during long-term follow-up (98.4%) and low relevant complication rate with need for secondary catheter reintervention (3.3%) or surgical treatment (0.9%).The primary author of the article is (b)(6).

• Brand Name: AMPLATZER DUCT OCCLUDER (UNKNOWN)
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12610863
• MDR Text Key: 282354473
• Report Number: 2135147-2021-00402
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 14