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 2020-03-25 for AMPLATZER? TORQVUE? (UNKNOWN) manufactured by Aga Medical Corporation.
[184948377]
As reported in a research article, out of 107 patients implanted with either and amplatzer cardiac plug or amulet, 3 patients had major bleeding and pericardial tamponade during 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
Patient Sequence No: 1, Text Type: N, H10
[184948378]
It was reported through a research article identifying amplatzer cardiac plug and amulet that may be related to complications and death. Details are listed in the article, titled "late clinical outcomes of lambre versus amplatzer occluders for left atrial appendage closure. " it was reported in the article that 42 patient were implanted with an amplatzer cardiac plug, and 65 patients were implanted with an amulet. The average age of the patients were 76 years old with 45 of them female. The patients have a history of arterial hypertension, diabetes mellitus, coronary artery disease, congestive heart failure, prior stroke, and prior major bleeding. The inclusion criteria for these studies are patients 18 years old or older with nonvalvular atrial fibrillation with a high risk for cardioembolic events. Three of the patients had major bleeding and pericardial tamponade during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00135 |
| MDR Report Key | 9880430 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-03-25 |
| 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? TORQVUE? (UNKNOWN) |
| Generic Name | CATHETER, PERCUTANEOUS |
| Product Code | DQY |
| Date Received | 2020-03-25 |
| 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 | 2020-03-25 |