FDA Adverse Event
Injury
Summary report: N
GORE® CARDIOFORM ASD OCCLUDER
MDR report key: 9480798
·
Received December 17, 2019
Report
- Report Number
- 2017233-2019-01250
- Event Type
- Injury
- Date Received
- December 17, 2019
- Date of Event
- November 21, 2019
- Report Date
- January 22, 2020
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MLV
- UDI-DI
- 00733132636488
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL CASE DETAILS: STATIC DEFECT MEASUREMENT WAS 10MM; THE PATIENT HAD A DEFICIENT AORTIC RIM (>5MM); THERE WAS A SUFFICIENT POSTERIOR RIM (NO MEASUREMENTS). THE GORE® CARDIOFORM ASD OCCLUDER INSTRUCTIONS FOR USE LIST EMBOLIZATION AS POTENTIAL CLINICAL AND DEVICE ADVERSE EVENT.
Additional Manufacturer Narrative · 1
PMA/510(K) # :P050006.
Description of Event or Problem · 1
IT WAS REPORTED THE PHYSICIAN IMPLANTED A 27MM GORE® CARDIOFORM ASD OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT ON (B)(6) 2019. THE DEFECT WAS NOT BALLOON SIZED. TRANSTHORACIC ECHOCARDIOGRAPHY ON (B)(6) 2019 SHOWED THE DEVICE HAD EMBOLIZED TO THE LEFT PULMONARY ARTERY. THE EMBOLIZED DEVICE WAS REMOVED BY SNARE IN A TRANSCATHETER PROCEDURE AND A 32MM GORE® CARDIOFORM ASD OCCLUDER WAS IMPLANTED. THE PATIENT IS CURRENTLY STABLE AND DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1274545 | GORE® CARDIOFORM ASD OCCLUDER | TRANSCATHETER, SEPTAL OCCLUDER | MLV | W.L. GORE & ASSOCIATES | ASD27A | 20858365 | 00733132636488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |