N
Patient 1
THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION, THEY REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
MAUDE MDR 6429553
- MDR report key
- 6429553
- Report number
- 2031527-2017-00120
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-11-22
- Date received
- 2017-03-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MICHELLE CAULFIELD
- Address
- 2 MUSICK IRVINE CA 92618 US
- Phone
- 877-877-8778
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AFX | BIFURCATED | ENDOLOGIX INC. | MIH | BA28-110/I20-30 | 1283284-024 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-23 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION. AN IN-HOUSE CLINICAL REVIEW OF PATIENT IMAGING IDENTIFIED THE COMPLETION OF A SUBSEQUENT ENDOVASCULAR PROCEDURE WHERE THE PHYSICIAN IMPLANTED A SUPRARENAL AORTIC EXTENSION AS WELL AS A LIMB EXTENSION TO RESOLVE AN UNKNOWN ISSUE.
N
Patient 1
CLINICAL EVALUATION: AT THE COMPLETION OF THE CLINICAL EVALUATION, BASED ON THE INFORMATION RECEIVED, THE FOLLOWING WERE CONFIRMED: SECONDARY PROCEDURE TO PLACE A SUPRARENAL CUFF AND RIGHT ILIAC LIMB EXTENSIONS FOR THE ENDOLEAK TYPE IA AND TYPE IB OF THE RIGHT LIMB. ADDITIONALLY THERE WAS EVIDENCE TO REASONABLY SUPPORT THE FOLLOWING OBSERVATIONS: ENDOLEAK TYPE IA AFTER SUPRARENAL CUFF PLACEMENT THAT WAS TREATED WITH A NON-ENDOLOGIX BALLOON EXPANDABLE STENT AND ANGIOPLASTY. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED DEFINITIVELY. THE EVENT DEVICE WAS NOT RETURNED FOR FURTHER EVALUATION. CLINICAL FOUND EVIDENCE TO REASONABLY SUGGEST THE FOLLOWING CONTRIBUTING FACTORS TO THE REPORTED EVENT: OFF LABEL, LOW PLACEMENT OF THE INITIAL CUFF, AND INFRARENAL NECK ANGLE.
D
Patient 1
ADDITIONAL PATIENT RECORDS RECEIVED TO DATE INDICATE THAT A PERSISTENT TYPE 1A ENDOLEAK WAS RESOLVED BY A TERTIARY PROCEDURE DURING WHICH A NON-ENDOLOGIX STENT WAS IMPLANTED.