FDA Adverse Event
Injury
Summary report: N
GORE® EXCLUDER® AAA ENDOPROSTHESIS
MDR report key: 5446662
·
Received February 19, 2016
Report
- Report Number
- 2017233-2016-00137
- Event Type
- Injury
- Date Received
- February 19, 2016
- Date of Event
- December 12, 2013
- Report Date
- March 17, 2016
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS. PATIENT MEDICATIONS: TAHOR, KARDEGIC, DOLIPRANE, AVODART, ZYLORIC, EUPHANTHOL, COVERSYL, SECTRAL. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2013, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GOREEXCLUDER AAA ENDOPROSTHESES FEATURING C3DELIVERY SYSTEM. ON (B)(6) 2013 A NEW TYPE II ENDOLEAK WAS DISCOVERED VIA ANGIOGRAPHY THAT IS FED BY THE INFERIOR MESENTERIC ARTERY. THE ANEURYSM SAC DIAMETER APPEARED TO BE 52 MM. FOLLOW UP ANGIOGRAPHY MEASUREMENTS WERE AS FOLLOWS: ON (B)(6) 2014: 53 MM, (B)(6) 2014: 58 MM ON (B)(6) 2014 THE TYPE II ENDOLEAK WAS SUCCESSFULLY SOLVED VIA EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY. THE PATIENT DID WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 103116 | GORE® EXCLUDER® AAA ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 10884822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| O |