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 2020-03-04 for AMPLATZER? DUCT OCCLUDER II CVD0095 manufactured by Aga Medical Corporation.
[183948850]
Further information regarding this event has been requested. The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10
[183948851]
On an unknown date an amplatzer? Duct occluder ii was implanted in a (b)(6) month old baby. At the time of implant the amplatzer? Duct occluder ii was with the left pulmonary artery (lpa) and initially caused a mild increase in lpa gradient. The gradient continued to increase over time. When the patient was (b)(6) years old they underwent a balloon angioplasty to dilate the area of the stenosis. The patient was reported to be doing well post procedure and the physician continues to monitor progress. Additional information cannot be obtained.
Patient Sequence No: 1, Text Type: D, B5
[184391868]
An event of disc protrusion into the left pulmonary artery causing stenosis and high gradient 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2135147-2020-00102 |
| MDR Report Key | 9788790 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-04 |
| 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? DUCT OCCLUDER II |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-04 |
| Model Number | CVD0095 |
| Catalog Number | CVD0095 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-04 |