MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-04 for AMPLATZER PICCOLO OCCLUDER 9-PDAP-04-04-L manufactured by Aga Medical Corporation.
[183947003]
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
[183947004]
A (b)(6) kg baby underwent closure and a 04-04 amplatzer piccolo occluder was implanted without any evidence of device migration lpa obstruction. Post implant the baby had a repeat echocardiogram 4 hours following implant procedure and it was noted that the device migration into the lpa causing a residual shunt. The baby was taken back to the cath lab and had the device removed without difficulty using a snare. An amplatzer vascular plug ii was implanted. Post implant lpa stenosis was noted and it was not possible to remove the device so instead a stent to open the lpa was used. Once the baby reaches 6 to 7 kilograms in weight the lpa may be opened and the stent removed with lpa repair. The patient is recovering. Manufacturer report number: 2135147-2020-00101.
Patient Sequence No: 1, Text Type: D, B5
[184825955]
Additional information: an event of migration of the 04-04 piccolo occluder was reported. The results of the investigation are inconclusive since the device was not returned for analysis. Confirmation of implant of the correct device size to fit the defect could not be performed because insufficient information was received from the field. 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 | 2135147-2020-00099 |
| MDR Report Key | 9786920 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-03-20 |
| 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 PICCOLO OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-04 |
| Model Number | 9-PDAP-04-04-L |
| Catalog Number | 9-PDAP-04-04-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. Required No Informationntervention | 2020-03-04 |