FDA Adverse Event
Injury
Summary report: N
AMPLATZER MUSCULAR VSD OCCLUDER
MDR report key: 3231717
·
Received July 17, 2013
Report
- Report Number
- 2135147-2013-00061
- Event Type
- Injury
- Date Received
- July 17, 2013
- Date of Event
- May 1, 2013
- Report Date
- June 27, 2013
- Manufacturer
- AGA MEDICAL CORPORATION
- Product Code
- MLV
- PMA / PMN Number
- P040040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) COULD NOT EVALUATE THE MUSCVSD INVOLVED IN THIS INCIDENT SINCE IT WAS NOT RETURNED TO US. THE DEVICE'S MANUFACTURING RECORDS COULD NOT BE REVIEWED SINCE THE LOT NUMBER FOR THE AFFECTED PRODUCT WAS NOT PROVIDED TO (B)(4). HOWEVER, EACH DEVICE IS INSPECTED BY CERTIFIED OPERATORS TO ENSURE EACH DEVICE IS ACCEPTABLE DURING MANUFACTURING AND PRIOR TO SHIPMENT.
Description of Event or Problem · 1
AFTER THE IMPLANTATION OF THE 12MM AMPLATZER MUSCULAR VSD OCCLUDER (MUSCVSD), AV BLOCK OCCURRED. THE MUSCVSD WAS SURGICALLY REMOVED. EVENT, IMPLANT AND EXPLANT DATES OF (B)(6) 2013 ARE ESTIMATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332347 | AMPLATZER MUSCULAR VSD OCCLUDER | CARDIAC OCCLUSION DEVICE | MLV | AGA MEDICAL CORPORATION | 9-VSD-MUSC-012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |