FDA Adverse Event
Injury
Summary report: N
GORE® ACUSEAL VASCULAR GRAFT
MDR report key: 4243349
·
Received November 11, 2014
Report
- Report Number
- 2017233-2014-00586
- Event Type
- Injury
- Date Received
- November 11, 2014
- Report Date
- December 2, 2014
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- DSY
- PMA / PMN Number
- K130215
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.CONCLUSIONS: THE DEVICE REMAINED IMPLANTED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. WITHOUT ADDITIONAL INFORMATION IT IS IMPOSSIBLE TO FURTHER INVESTIGATE THIS EVENT.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2014, A PATIENT WAS IMPLANTED WITH A GORE® ACUSEAL VASCULAR GRAFT FOR ARTERIOVENOUS ACCESS. THE DIALYSIS CENTER REPORTED TO GORE THAT THE GRAFT CLOTTED WITHIN THE FIRST SEVERAL WEEKS POST IMPLANTATION DATE. THE GRAFT IS CURRENTLY OPEN AND ABLE TO BE DIALIZED.
Description of Event or Problem · 1
THE GRAFT IS STILL IMPLANTED BUT THE CLOTS HAVE BEEN REMOVED AND IT IS DIFFICULT TO DIALYZE THE PATIENT THROUGH THE GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725529 | GORE® ACUSEAL VASCULAR GRAFT | PROSTHESIS, VASCULAR GRAFT | DSY | W.L. GORE & ASSOCIATES | 4486677PP020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Required Intervention |