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 2019-04-11 for AMPLATZER? DUCT OCCLUDER (UNKNOWN) manufactured by Aga Medical Corporation.
[141649714]
An event of death following aortic dissection 10 years following implant was reported. 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; however, no evidence was provided of a device malfunction.
Patient Sequence No: 1, Text Type: N, H10
[141649715]
Ten years following implant of an amplatzer duct occluder, the patient expired suddenly and unexpectedly due to aortic dissection. Additional information has been requested regarding device, hospital, date of implant, date of death, autopsy report and initial implant medical reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2019-00103 |
| MDR Report Key | 8503722 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-11 |
| Date of Report | 2019-04-11 |
| Date Mfgr Received | 2019-03-19 |
| Date Added to Maude | 2019-04-11 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| 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? DUCT OCCLUDER (UNKNOWN) |
| Generic Name | OCCLUDER, PATENT DUCTUS, ARTERIOSUS |
| Product Code | MAE |
| Date Received | 2019-04-11 |
| 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. Death; 2. Hospitalization | 2019-04-11 |