AMPLATZER SEPTAL OCCLUDER
Report
- Report Number
- 2135147-2024-00741
- Event Type
- Malfunction
- Date Received
- February 20, 2024
- Date of Event
- January 29, 2024
- Report Date
- February 20, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- MLV
- UDI-DI
- 00811806010199
- PMA / PMN Number
- P000039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AN EVENT OF DEVICE DEFORMITY DURING IMPLANTATION WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS 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 DEFINED MANUFACTURING SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.
IT WAS REPORTED THAT ON (B)(6) 2024, A 24MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 10F AMPLATZER TORQVUE DELIVERY SYSTEM. THE DEVICE DEFORMED DURING IMPLANTATION INTO A COBRA SHAPE. A REPLACEMENT 24MM AMPLATZER SEPTAL OCCLUDER (LOT: 9210017) WAS USED TO COMPLETE THE PROCEDURE USING AN 10F TORQVUE DELIVERY SYSTEM. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO BENDS OR KINKS IN THE DELIVERY SYSTEM. THERE WERE NO PATIENT ISSUES AND NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1086378 | AMPLATZER SEPTAL OCCLUDER | TRANSCATHETER SEPTAL OCCLUDER | MLV | ABBOTT MEDICAL | 9094838 | 00811806010199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | AMPLATZER TORQVUE DELIVERY SYSTEM9-ATV10F45/80 |