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 2020-03-24 for AMPLATZER MUSCULAR VSD OCCLUDER 9-VSD-MUSC-018 manufactured by Aga Medical Corporation.
[184828195]
An event of the device being missized, the patient going into vtach, low blood pressure, and patient death "days" later due to complications of a myocardial infarction was reported. The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[184828196]
On (b)(6) 2020, the physician attempted to close a ventricular septal defect with a 9-vsd-musc-014 lot # 6243914 but the device prolapsed through the defect. It was mis-sized, never released and removed from the patient? S body. The physician then decided to try a larger size, a 9-vsd-musc-018 lot # 6119716 but this device also slipped through the defect and was mis-sized. The physician re-sheathed the 18mm device and removed it from the patient. During the procedure the patient became unstable. The patient experienced vtach twice and also had to be temporarily paced. The patient's blood pressure dropped very low. The patient was sent back to icu while the cardiology team discussed next steps for the patient. The patient died days later. The physician does not attribute the death to the procedure or the device. The patient was very ill and the physician states the cause of death was due to complications of a myocardial infarction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135147-2020-00106 |
| MDR Report Key | 9875863 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2017-08-31 |
| Date Added to Maude | 2020-03-24 |
| 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 MUSCULAR VSD OCCLUDER |
| Generic Name | TRANSCATHETER SEPTAL OCCLUDER |
| Product Code | MLV |
| Date Received | 2020-03-24 |
| Model Number | 9-VSD-MUSC-018 |
| Catalog Number | 9-VSD-MUSC-018 |
| Lot Number | 6119716 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-24 |