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 2020-03-19 for AMPLATZER PICCOLO OCCLUDER 9-PDAP-04-02-L manufactured by Aga Medical Corporation.
[184231437]
An event of patient death due to pulmonary hypertension three days after placement of a piccolo device to treat a pda was reported. The results of the investigation are inconclusive since the device remains implanted was not returned for analysis. Confirmation of correct device sizing could not be performed as the measurements of the defect were not received. The cause of the reported event could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[184231438]
On (b)(6) 2020, a 4-2 amplatzer piccolo was selected for implant intraductal. The pda dimension is unknown. On (b)(6) 2020 the patient developed pulmonary hypertension, which was not present before the closure of the pda. The patient decompensated throughout the day and ultimately expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00123 |
| MDR Report Key | 9857641 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2020-03-19 |
| Model Number | 9-PDAP-04-02-L |
| 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. Required No Informationntervention | 2020-03-19 |