MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-03 for AMPLATZER PICCOLO OCCLUDER 9-PDAP-05-02-L manufactured by Aga Medical Corporation.
[183946446]
As reported in a research article, left pulmonary artery obstruction were noted during follow up after implantation with a 5-2 amplatzer piccolo and the device was explanted. 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 instructions for use, arten600042307 version a, "contraindications: weight <700 grams at time of the procedure" a piccolo device was not indicated for use in this patient. The cause of the reported event could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[183946447]
Reference manufacturing report number: 2135147-2020-00090, 2135147-2020-00091, 2135147-2020-00092, 2135147-2020-00094. It was reported through a research article identifying amplatzer piccolo that may be related to a severe left pulmonary artery obstruction. Details are listed in the article, titled "device deformation and left pulmonary artery obstruction after transcatheter patent ductus arteriosus closure in preterm infants. " it was reported in the article that in (b)(6) 2016, 14 patients underwent transcatheter patent ductus arteriosus (pda) closure. A 21 days old patient that weigh 608 grams with pda diameter of 2. 1mm and pda length of 7. 7mm was implanted with a 5-2 amplatzer piccolo. During follow up, severe left pulmonary artery obstruction was observed and the device was removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00093 |
| MDR Report Key | 9783105 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Remedial Action | OT |
| 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 | 2020-03-03 |
| Model Number | 9-PDAP-05-02-L |
| Catalog Number | 9-PDAP-05-02-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. Other; 2. Required No Informationntervention | 2020-03-03 |