AMPLATZER MUSCULAR VSD OCCLUDER
Report
- Report Number
- 2135147-2023-04088
- Event Type
- Malfunction
- Date Received
- September 20, 2023
- Date of Event
- August 28, 2023
- Report Date
- October 13, 2023
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- MLV
- UDI-DI
- 00811806011837
- PMA / PMN Number
- P040040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AN EVENT OF DEVICE DEFORMITY WAS REPORTED. THE DEVICE WAS RETURNED TO ABBOTT FOR INVESTIGATION AND MET FUNCTIONAL SPECIFICATIONS WHEN ANALYZED UNDER NON-PHYSIOLOGICAL CONDITIONS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL DEFINED MANUFACTURING SPECIFICATIONS. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE SIZE OF THE DELIVERY SYSTEM USED WAS UNKNOWN.
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION NA.
IT WAS REPORTED THAT ON (B)(6) 2023 A 16MM AMPLATZER VSD OCCLUDER (LOT: 7781019) WAS CHOSEN FOR IMPLANTATION UTILIZING AN UNKNOWN DELIVERY SYSTEM. A COBRA DEFORMATION OCCURRED. A REPLACEMENT 14MM AMPLATZER VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER (LOT: 7993734) WAS THEN ATTEMPTED TO BE USED BUT ALSO HAD A COBRA SHAPED DEFORMATION. THE PROCEDURE WAS ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO ANGULATION OR KINK IN THE DELIVERY SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1589453 | AMPLATZER MUSCULAR VSD OCCLUDER | TRANSCATHETER SEPTAL OCCLUDER | MLV | ABBOTT MEDICAL | 7993734 | 00811806011837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |