FDA Adverse Event
Injury
Summary report: N
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP
MDR report key: 11686262
·
Received April 19, 2021
Report
- Report Number
- 3011706110-2021-00014
- Event Type
- Injury
- Date Received
- April 19, 2021
- Date of Event
- March 22, 2021
- Report Date
- April 19, 2021
- Manufacturer
- ATRICURE, INC.
- Product Code
- PZX
- PMA / PMN Number
- K191413
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) PROV45 LOT# 106455 WAS INVESTIGATED AND COMPLAINT COULD NOT BE CONFIRMED FOR TISSUE TEARING. BOTH KNOTS WERE EXAMINED AND THERE WERE NO ABNORMALITIES NOTED. THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL INSPECTIONS AND WAS FOUND TO BE CONFORMING.
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6) 2021 A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A CONVERGENT PROCEDURE AND LEFT ATRIAL APPENDAGE MANAGEMENT UTILIZING A PROV45. AS THE SURGEON WAS REMOVING THE PROV45 TO REARTICULATE THE DEVICE A PERFORATION OCCURRED. THE PROCEDURE WAS CONVERTED TO A STERNOTOMY AND THE PATIENT WAS PLACED ON-PUMP. SURGEON THEN STAPLED THE APPENDAGE OFF AND SUTURED THE PERFORATION. THIS WAS A PROCEDURAL COMPLICATION. THERE WAS NO REPORTED DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586963 | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP | ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP | PZX | ATRICURE, INC. | PROV45 | 106455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |