ANEURX ABDOMINAL STENT GRAFT SYSTEM
Report
- Report Number
- 2953200-2013-00301
- Event Type
- Death
- Date Received
- February 20, 2013
- Date of Event
- March 15, 2015
- Report Date
- April 8, 2015
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P990020
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4).
(B)(4). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT MIGRATION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (AORTIC NECK DILATATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (AORTIC NECK DILATATION).
ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THERE WAS DISEASE PROGRESSION WITH AORTIC NECK DILATATION RESULTING IN THE STENT GRAFT MIGRATION AND A TYPE I ENDOLEAK. IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS AGO AN ENDURANT AORTIC CUFF (B)(4) WAS IMPLANTED AND THE MIGRATION AND TYPE I ENDOLEAK WERE SUCCESSFULLY RESOLVED.
AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 11 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. CURRENT DIAMETER OF THE AORTIC NECK IS 32-33 MM. IT WAS REPORTED THAT THE STENT GRAFT WAS FOUND TO HAVE MIGRATED APPROXIMATELY 2 CM, WITH NO EVIDENCE OF AN ENDOLEAK. THE POSSIBLE CAUSE OF THE MIGRATION MAY BE AORTIC NECK DILATATION. THE PATIENT WILL BE MONITORED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
FILMS REVIEW AND ANALYSIS: REVIEW OF SEVERAL SHORT RETURNED FILMS ON VIDEO SHOWED THAT AFTER THE ENDURANT AUI WAS IMPLANTED CONTRAST WITH BLUSH APPEARANCE WAS SEEN OUTSIDE THE AUI; NEAR THE TAPERED SECTION. AFTER IMPLANTING ANOTHER MANUFACTURER'S STENT GRAFT, THE ENDOLEAK RESOLVED. THE TYPE AND CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED FROM THE IMAGES PROVIDED. THIS MAY HAVE BEEN A TYPE IV OR TYPE III FABRIC ENDOLEAK.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT PRESENTED TO THE ER WITH A RUPTURED ANEURYSM. IT WAS FOUND THAT THE ENDURANT CUFF AND ANEURX BIFURCATE HAD SEPARATED. THE ENDURANT CUFF WAS STILL IN PLACE; THE ANEURX BIFURCATE HAD SLIPPED. THE GAP BETWEEN THE CUFF AND THE BIFURCATE WAS THE CAUSE. PER THE PHYSICIAN, THE EVENT WAS RELATED TO THE DEVICE AND PROCEDURE. THE PATIENT RECEIVED TREATMENT WHERE AN ENDURANT AUI STENT GRAFT WAS USED. AFTER DEPLOYMENT, AN ENDOLEAK WAS NOTICED. IT WAS ORIGINALLY THOUGHT TO BE TYPE I ENDOLEAK, THEREFORE ANOTHER ENDURANT CUFF WAS ADDED. ANOTHER ANGIOGRAM WAS DONE AND SHOWED THAT THE ENDOLEAK PERSISTED. THE PHYSICIAN INSERTED A PIGTAIL CATHETER INTO THE STENT GRAFT, AND IT WAS DETERMINED THAT THE ENDOLEAK WAS COMING FROM THE MIDDLE OF THE ENDURANT AUI STENT GRAFT. THE PHYSICIAN STATED THAT IT WAS EITHER A TEAR OR BLUSH. THE PHYSICIAN FELT THAT IT WAS NECESSARY TO USE A CONVERTER STENT GRAFT FROM ANOTHER MANUFACTURER TO RELINE THE STENT GRAFTS, AND THE ENDOLEAK RESOLVED. THE PHYSICIAN STATED THE EVENT WAS RELATED TO THE DEVICE. THE PATIENT EXPIRED ON THE SAME DAY DUE TO COMPLICATIONS OF RUPTURED ABDOMINAL AORTIC ANEURYSM. PER THE PHYSICIAN, THE CAUSE OF ANEURX BIFURCATE MIGRATION LED TO SEPARATION BETWEEN THE ANEURX BIFURCATE AND THE ENDURANT CUFF WAS UNKNOWN; THE CAUSE OF POSSIBLE TEAR OR BLUSH WITH THE ENDURANT AUI STENT GRAFT WAS ALSO UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74271 | ANEURX ABDOMINAL STENT GRAFT SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC CARDIOVASCULAR | M01F750381 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00080 YR | Death| R |