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 2020-03-06 for AMPLATZER PICCOLO OCCLUDER 9-PDAP-04-02-L manufactured by Aga Medical Corporation.
[183949205]
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
[183949206]
On (b)(6) 2019, a 4/2mm amplatzer piccolo occluder was implanted in a premature baby born at (b)(6) weeks gestation and weighed (b)(6) kilograms. The infant had a history of enterocolitis related to prematurity. The device was successfully placed with no evidence of aortic or pulmonary protrusion. Post implant, an aortic obstruction and increase gradient was reported. One month post implant on (b)(6) 2019, it was reported that the device migrated slightly towards the aorta. The physician decided to continue to monitor the infant. The infant remains in the nicu in stable condition.
Patient Sequence No: 1, Text Type: D, B5
[184833768]
An event of migration of the 04-02 piccolo occluder into the aorta was reported. The results of the investigation are inconclusive since the device was not returned for analysis. A review of the measurements as reported from the field was performed. Per the sizing table in the instructions for use, arten600042307 version a, the correct size piccolo occluder for the measurements provided was 04-02, the size of the implanted device. 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 | 2135147-2020-00107 |
| MDR Report Key | 9802234 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-03-20 |
| Date Added to Maude | 2020-03-06 |
| 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 PICCOLO OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-06 |
| Model Number | 9-PDAP-04-02-L |
| Catalog Number | 9-PDAP-04-02-L |
| 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 | 2020-03-06 |