TALENT AAA STENT GRAFT
Report
- Report Number
- 2953200-2017-01927
- Event Type
- Injury
- Date Received
- December 6, 2017
- Date of Event
- February 1, 2007
- Report Date
- December 6, 2017
- Manufacturer
- MEDTRONIC CARDIOVASCULAR SANTA ROSA
- Product Code
- MIH
- PMA / PMN Number
- P070027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; INFLUENCE OF SEVERE INFRARENAL AORTIC NECK ANGULATION ON COMPLICATIONS AT THE PROXIMAL NECK FOLLOWING ENDOVASCULAR AAA REPAIR: A EUROSTAR STUDY ROEL HOBO, MSC; JUR KIEVIT, MD; LINA J. LEURS, MSC; AND JACOB BUTH, MD, PHD, FRCS (J ENDOVASC THER 2007;14:1¿11).
A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON AN UNKNOWN DATE. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA ENDOLEAK, STENT GRAFT MIGRATION, ANEURYSM RUPTURE, SECONDARY INTERVENTION, PROXIMAL NECK DILATATION, DEATH (ANEURYSM RELATED) PURPOSE: TO EXAMINE THE INFLUENCE OF SEVERE INFRARENAL NECK ANGULATION (SNA) ON COMPLICATIONS AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM (AAA). METHODS: FROM OCTOBER 1996 TO JANUARY 2006, 5183 PATIENTS WHO UNDERWENT ENDOVASCULAR ANEURYSM REPAIR USING A TALENT, ZENITH, OR EXCLUDER STENT-GRAFT WERE ENROLLED INTO THE EUROSTAR REGISTRY. INCIDENCE OF PROXIMAL TYPE I ENDOLEAK, STENT-GRAFT MIGRATION, PROXIMAL NECK DILATATION, ANEURYSM RUPTURE, SECONDARY INTERVENTIONS, AND ALL-CAUSE AND ANEURYSM RELATED MORTALITY WERE COMPARED BETWEEN PATIENTS WITH AND WITHOUT SEVERE INFRARENAL NECK ANGULATION (>60 DEGREE ANGLE BETWEEN THE INFRARENAL AORTIC NECK AND THE LONGITUDINAL AXIS OF THE ANEURYSM). RESULTS: IN THE SHORT TERM (BEFORE DISCHARGE), PROXIMAL TYPE I ENDOLEAK (OR 2.32, 95% CI 1.60 TO 3.37, P=0.0001) AND STENT-GRAFT MIGRATION (OR 2.17, 95% CI 1.20 TO 3.91, P=0.0105) WERE OBSERVED MORE FREQUENTLY IN PATIENTS WITH SNA. OVER THE LONG TERM, HIGHER INCIDENCES OF PROXIMAL NECK DILATATION LESS THAN OR EQUAL TO 4 MM (HR 1.26, 95% CI 1.11 TO 1.43, P=0.0004), PROXIMAL TYPE I ENDOLEAK (HR 1.80, 95% CI 1.25 TO 2.58, P=0.0016), AND NEED FOR SECONDARY INTERVENTIONS (HR 1.29, 95% CI 1.00 TO 1.67, P=0.0488) WERE SEEN IN PATIENTS WITH SNA. ALL CAUSE MORTALITY, ANEURYSM-RELATED MORTALITY, AND RUPTURE OF THE ANEURYSM WERE SIMILAR IN PATIENTS WITH AND WITHOUT SEVERE NECK ANGULATION. IN THE SUBGROUP OF PATIENTS WITH AN EXCLUDER ENDOGRAFT, PROXIMAL ENDOLEAK AT THE COMPLETION ANGIOGRAM (OR 4.49, 95% CI 1.31 TO 15.32, P=0.0166) AND LONG-TERM PROXIMAL NECK DILATATION (HR 1.67, 95% CI 1.20 TO 2.33, P=0.0026) WERE MORE FREQUENTLY OBSERVED IN PATIENTS WITH SNA. IN THE ZENITH SUBGROUP, PROXIMAL ENDOLEAK AT THE COMPLETION ANGIOGRAM (OR 2.62, 95% CI 1.49 TO 4.63, P=0.0009) AND PROXIMAL STENT-GRAFT MIGRATION BEFORE DISCHARGE (OR 2.34, 95% CI 1.06 TO 5.19, P=0.0353) WERE MORE COMMON IN PATIENTS WITH SNA. IN THE TALENT SUBGROUP, LONG-TERM PROXIMAL ENDOLEAK (HR2.09, 95% CI 1.27 TO 3.44, P=0.0036), PROXIMAL NECK DILATATION (HR 1.29, 95% CI 1.05 TO 1.60, P=0.0168), AND SECONDARY INTERVENTIONS (HR 1.54, 95% CI 1.05 TO 2.24, P=0.0259) WERE MORE FREQUENTLY OBSERVED IN PATIENTS WITH SNA. CONCLUSION: SEVERE INFRARENAL AORTIC NECK ANGULATION WAS CLEARLY ASSOCIATED WITH PROXIMAL TYPE I ENDOLEAK, WHILE THE RELATIONSHIP WITH STENT-GRAFT MIGRATION WAS NOT CLEAR. EXCLUDER, ZENITH, AND TALENT STENT-GRAFTS PERFORM WELL IN PATIENTS WITH SEVERE NECK ANGULATION, WITH ONLY A FEW DIFFERENCES AMONG DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 866766 | TALENT AAA STENT GRAFT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC CARDIOVASCULAR SANTA ROSA | UNK-CV-SR-TAL AAA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |