MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for AMPLATZER VASCULAR PLUG II 9-AVP2 manufactured by Aga Medical Corporation.
[184391791]
Reference manufacturer report number 2135147-2020-00131. It was reported through a research article identifying amplatzer vascular plugs that may be related to a complications post procedure. Details are listed in the article, titled "elective percutaneous paravalvular leak closure under conscious sedation: procedural techniques and clinical outcomes. " it was reported in the article that from january 2013 to april 2018, a total of 37 patients had paravalvular (pvl) repaired using the amplatzer vascular plug. The patients have an average age of (b)(6) years old. 17 of the patients were male. The patients have a history of coronary artery disease, peripheral artery disease, cerebrovascular accident, hypertension, hyperlipidemia, diabetes, atrial fibrillation, chronic obstructive pulmonary disease, liver disease, and renal disease. All procedures were guided by transesophageal echocardiography (tee) under conscious sedation. A total of 54 pvls were repaired. Short term mortality during the first 30 days was 5. 4% (2 patients).
Patient Sequence No: 1, Text Type: D, B5
[184470776]
As reported in a research article, an amplatzer vascular plug ii was implanted off label to close a paravalvular leak and two of the 37 patients died within 30 days after the procedure. 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, artmt600539-003 revision a "the safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established. "
Patient Sequence No: 1, Text Type: N, H10
[184470777]
It was reported through a research article identifying amplatzer vascular plugs that may be related to a complications post procedure. Details are listed in the article, titled "elective percutaneous paravalvular leak closure under conscious sedation: procedural techniques and clinical outcomes. " it was reported in the article that from january 2013 to april 2018, a total of 37 patients had paravalvular (pvl) repaired using the amplatzer vascular plug. The patients have an average age of 69 years old. 17 of the patients were male. The patients have a history of coronary artery disease, peripheral artery disease, cerebrovascular accident, hypertension, hyperlipidemia, diabetes, atrial fibrillation, chronic obstructive pulmonary disease, liver disease, and renal disease. All procedures were guided by transesophageal echocardiography (tee) under conscious sedation. A total of 10 pvls were not repaired with procedural success and had residual shunt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00132 |
| MDR Report Key | 9862947 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| 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 II |
| Generic Name | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION |
| Product Code | KRD |
| Date Received | 2020-03-20 |
| Model Number | 9-AVP2 |
| 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. Death; 2. Required No Informationntervention | 2020-03-20 |