MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-19 for AMPLATZER? VASCULAR PLUG (UNKNOWN) CVD0105 manufactured by Aga Medical Corporation.
[184305528]
As reported in a research article, seven amplatzer vascular plugs were implanted off-label to attempt to close a pseudoaneurysm. 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 instruction for use, artmt600034447 revision b " the amplatzer? Vascular plug and amplatzer? Vascular plug ii are indicated for arterial and venous embolizations in the peripheral vasculature. "
Patient Sequence No: 1, Text Type: N, H10
[184305529]
As reported in a research article, a patient presented with repeated bleeding in her neck, she was stable and had no signs of infection or heart failure. On physical examination, there was a small yet actively bleeding cutaneous orifice in the suprasternal notch. Seven amplatzer vascular plugs were implanted off-label to attempt to close a pseudoaneurysm in a patient without success. The physicians completed an endovascular procedure that was able to simultaneously treat the failing aortic valve and the pseudoaneurysm in the ascending aorta, mimicking a bentall-de bono procedure, dubbed the endo-bentall procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00095 |
| MDR Report Key | 9857096 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-19 |
| 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? VASCULAR PLUG (UNKNOWN) |
| Generic Name | AMPLATZER VASCULAR PLUG |
| Product Code | KRD |
| Date Received | 2020-03-19 |
| Model Number | CVD0105 |
| Catalog Number | CVD0105 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other; 2. Required No Informationntervention | 2020-03-19 |