MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-04 for AMPLATZER? CARDIAC PLUG manufactured by Aga Medical Corporation.
[183947218]
As reported in a research article, a one patient had an amplatzer vascular plug iii implanted off label to close a leak after incomplete closure of the laa with a cardiac plug. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined. Please note, per the instructions for use for the amplatzer vascular plug iii, 600229-004 revision a, "the safety and effectiveness of this device for cardiac uses (e. G. Patient ductus arteriosus, paravalvular leak closures) and neurological uses have not been established. "
Patient Sequence No: 1, Text Type: N, H10
[183947219]
It was reported through a research article identifying amplatzer cardiac plug that may be related to redo procedure requiring implant of a 14mm amplatzer vascular plug iii. Specific patient information is documented as unknown. Details are listed in the attached article, titled "interventional treatment of incomplete seal after transcatheter or surgical left atrial appendage closure. "
Patient Sequence No: 1, Text Type: D, B5
[184391866]
It was reported through a research article identifying amplatzer cardiac plug that may be related to redo procedure requiring implant of a 14mm amplatzer vascular plug iii. Transcatheter closure of the left atrial appendage (laa) for stroke prevention has emerged as an alternative to systemic anticoagulation in patients with atrial fibrillation (afib) and increased stroke risk. Specific patient information is documented as unknown. Details are listed in the attached article, titled "interventional treatment of incomplete seal after transcatheter or surgical left atrial appendage closure"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00050 |
| MDR Report Key | 9787742 |
| Report Source | LITERATURE |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAMELA YIP |
| Manufacturer Street | 5050 NATHAN LANE N |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | AGA MEDICAL CORPORATION |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLATZER? CARDIAC PLUG |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGA MEDICAL CORPORATION |
| Manufacturer Address | 5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-04 |