TALENT ABDOMINAL STENT GRAFT SYSTEM
Report
- Report Number
- 2953200-2013-00336
- Event Type
- Injury
- Date Received
- February 22, 2013
- Date of Event
- January 28, 2013
- Report Date
- April 12, 2013
- Manufacturer
- MEDTRONIC CARDIOVASCULAR SANTA ROSA
- Product Code
- MIH
- PMA / PMN Number
- P070027
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE; CAUSED BY ANOTHER DRUG/DEVICE (NEEDLE OR GUIDEWIRE). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TYPE II ENDOLEAK); ANOTHER DEVICE CAUSED FAILURE (NEEDLE OR GUIDEWIRE).
METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (ENDOLEAK).
A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 64 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE STENT GRAFTS WERE EXPLANTED APPROXIMATELY THREE WEEKS AGO DUE TO ANEURYSM GROWTH INITIALLY BELIEVED TO BE CAUSE BY A TYPE II ENDOLEAK. AT THE TIME OF EXPLANT HOLES WERE SEEN IN THE STENT GRAFT. THE CAUSE OF THE HOLES IS UNKNOWN; HOWEVER, THE PHYSICIAN COMMENTED THAT THE GRAFT MATERIAL COULD HAVE BEEN DAMAGED BY A NEEDLE OR SHARP TIP GUIDEWIRE DURING PREVIOUS INTERVENTIONS TO TREAT THE TYPE II ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.
THE DEVICE WAS EXPLANTED DURING SURGICAL CONVERSION DUE TO ANEURYSM EXPANSION FROM A TYPE II ENDOLEAK. AT EXPLANT HOLES WERE SEEN IN THE DISTAL IPSILATERAL LIMB. FROM THE EXAMINATION OF THE RETURNED DEVICES THE CAUSE OF THE ANEURYSM EXPANSION COULD NOT BE DETERMINED. HOWEVER, MULTIPLE FABRIC HOLES WERE OBSERVED ON THE BIFURCATE AND LIMBS WHICH MAY HAVE CONTRIBUTED TO THE AAA EXPANSION. SEVERAL SPRING AND C-BAR ABRASION RELATED HOLES WERE SEEN ON THE BIFURCATE AORTIC BODY. A 10 MM LENGTH SEAM SEPARATION WAS OBSERVED BETWEEN COVERED SPRINGS 1 <(>&<)> 2, AND NEAR THE ORIGIN OF THE IPSILATERAL LIMB (AT THE LEVEL OF THE GATE) A 7 MM LENGTH SEAM SEPARATION WAS ALSO OBSERVED. THE CAUSE OF THE SEAM SEPARATIONS COULD NOT BE DETERMINED. TWO HOLES WERE ALSO SEEN APPROXIMATELY 3 CM ABOVE THE DISTAL END OF THE IPSILATERAL LIMB; THESE WERE MOST LIKELY THE SAME HOLES SEEN BY THE PHYSICIAN DURING THE EXPLANT AND OBSERVED ON THE RETURNED VIDEO. THE CAUSE OF THE HOLES COULD NOT BE DETERMINED, BUT IT APPEARS UNLIKELY THAT THEY WERE CAUSED BY THE EMBOLIZATION PROCEDURE AS THESE HOLES HAD MORE OF AN ABRASION OR CREASE FATIGUE RELATED APPEARANCE, AND NOT PUNCTURE RELATED. SEVERAL HOLES WERE ALSO FOUND ON THE DISTAL END OF THE CONTRALATERAL LIMB, MOST LIKELY CAUSED BY THE UNDERLYING LIMB EXTENSION. THE CONTRALATERAL EXTENSION WAS FOUND TO HAVE A SEVERAL SMALL CREASE FATIGUE TEARS BETWEEN THE TWO MOST DISTAL STENTS; MOST LIKELY CAUSED BY LIMB ANGULATION AT THIS LOCATION. IMAGES PROVIDED DURING THE 3 - 5 YEAR FOLLOW-UP SHOWED CONTINUED AAA EXPANSION UP TO APPROXIMATELY 9 CM IN DIAMETER, AS WELL AS A PROBABLE TYPE II ENDOLEAK SEEN WITHIN THE RIGHT SIDE OF THE DISTAL SAC. IT IS LIKELY THAT THE TYPE II ENDOLEAK WAS THE PRIMARY CAUSE OF THE AAA EXPANSION. ALTHOUGH NO TYPE III FABRIC ENDOLEAK WAS REPORTED OR SEEN ON ANY OF THE RETURNED FILMS, IT IS POSSIBLE THAT SOME OF THE OBSERVED FABRIC TEARS MAY HAVE ALSO CONTRIBUTED TO THE ANEURYSM EXPANSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78091 | TALENT ABDOMINAL STENT GRAFT SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC CARDIOVASCULAR SANTA ROSA | V00035149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |