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 2020-03-03 for AMPLATZER SEPTAL OCCLUDER CVD0091 manufactured by Aga Medical Corporation.
[181827652]
As reported in a research article, 527 patients were implanted with an amplatzer septal occluder and some experienced complications post-procedure. 7 patients had cardiac arrhythmia, residual leak, cardiac arrest, or device embolism. 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
[181827653]
It was reported in a research article that a study was conducted from february 2016 to january 2019 where 527 patients were implanted with an amplatzer septal occluder and some experienced complications post-procedure. 7 patients had cardiac arrhythmia, residual leak, cardiac arrest, or device embolism. The embolized device was successfully retrieved and the procedure was completed with another device. The 1 patient who developed heart block after the procedure recovered spontaneously. One of the patients required cardiopulmonary resuscitation during the procedure, and cardiac activity was revived within a minute of cpr. Manufacturer report number: 2135147-2020-00088; 2135147-2020-00082.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00083 |
| MDR Report Key | 9781539 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-03-03 |
| 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 | 2020-03-03 |
| Model Number | CVD0091 |
| Catalog Number | CVD0091 |
| 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. Life Threatening; 2. Other; 3. Required No Informationntervention | 2020-03-03 |