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 2020-03-18 for AMPLATZER SEPTAL OCCLUDER manufactured by Aga Medical Corporation.
[184069440]
As reported in a research article, 245 patients were implanted with amplatzer septal occluder and complications during or after the procedure including two patients which had the device embolize, three where the device migrated, eleven patients had a residual shun and four patients had a transient ischemic attack and stroke. 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
[184069441]
It was reported through a research article identifying amplatzer septal occluders that may be related to a complications post procedure. Details are listed in the article, titled "transcatheter closure vs totally endoscopic robotic surgery for atrial septal defect closure: a single-center experience. " between january 2011 and may 2019, amplatzer septal occluders were implanted in 245 patients. The median age was 39, with 180 of them being women. The patients had the following comorbidities: atrial fibrillation, transient ischemic attack (tia), stroke, lung disease, hypertension, coronary artery disease, and diabetes. Complications during and post procedure includes: residual shunt (11), device migration (3), device embolization (2), tia and stroke (4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00118 |
| MDR Report Key | 9850642 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-18 |
| 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 SEPTAL OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-18 |
| 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 | 2020-03-18 |