TALENT AAA STENT GRAFT SYSTEM
Report
- Report Number
- 2953200-2012-02295
- Event Type
- Injury
- Date Received
- November 30, 2012
- Report Date
- November 2, 2012
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- MIH
- PMA / PMN Number
- P070027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). RESULTS: INHERENT RISK OF PROCEDURE (RENAL FAILURE, OCCLUSION); (CAUSE OF EVENTS ARE UNKNOWN). CONCLUSION: (CAUSE OF EVENTS ARE UNKNOWN).
MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: STRATEGIES TO TACKLE UNRECOGNIZED BILATERAL RENAL ARTERY OCCLUSION AFTER ENDOVASCULAR ANEURYSM REPAIR, JOHN ADU, NICHOLAS J. CHESHIRE, CELIA V. RIGA, MOHAMAD HAMADY, AND COLIN D. BICKNELL, LONDON, UNITED KINGDOM. BACKGROUND: UNINTENTIONAL RENAL ARTERY OCCLUSION AFTER ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) IS AN UNCOMMON PHENOMENON. THE SEQUELAE FROM THIS SPECIFIC COMPLICATION ARE SEVERE; CONSEQUENTLY, THE TOPIC OF RENAL ARTERY COVERAGE IS A PERTINENT ISSUE. WE PRESENT A CASE SERIES OF PATIENTS UNDERGOING EVAR WITH UNINTENTIONAL RENAL ARTERY COVERAGE, REVIEW THE TREATMENT OPTIONS AVAILABLE, AND SUGGEST A TREATMENT ALGORITHM FOR THIS SCENARIO BASED ON THE EVIDENCE. METHODS AND RESULTS: WE REPORT FOUR PATIENTS WHO WERE FOUND TO HAVE RENAL ARTERY OCCLUSION AFTER EVAR DETECTED UP TO 5 WEEKS POSTOPERATIVELY. RENAL REVASCULARIZATION WAS ACHIEVED USING ENDOVASCULAR RENAL ARTERY STENTING IN TWO PATIENTS, AND OPEN HEPATO-SPLENO-RENAL BYPASS IN THE REMAINING TWO CASES. TREATMENT STRATEGIES USED LED TO SYMPTOM RESOLUTION AND RECOVERY OF RENAL FUNCTION IN ALL CASES. CONCLUSIONS: BOTH OPEN AND ENDOVASCULAR TECHNIQUES MAY BE USED AS PROCEDURES TO TREAT THIS CONDITIONED THE CHOICE OF PROCEDURE IS PRIMARILY DETERMINED BY ACCESSIBILITY OF THE RENAL ORIFICE. A (B)(6) MAN UNDERWENT AN ENDOVASCULAR REPAIR OF AN INFRARENAL AAA USING A MEDTRONIC TALENT STENT GRAFT ((B)(4)). AN OPEN REPAIR OF A LEFT COMMON FEMORAL ARTERY ANEURYSM WAS ALSO PERFORMED. HE UNDERWENT THE PROCEDURE SEEMINGLY WITHOUT ANY COMPLICATIONS, BUT BECAME ANURIC POSTOPERATIVELY, REQUIRING RENAL REPLACEMENT THERAPY AT A REGIONAL DIALYSIS UNIT. CT SCANNING DEMONSTRATED COVERAGE OF BOTH RENAL ARTERIES BY THE STENT-GRAFT MAIN BODY FABRIC, AND HE WAS THEREFORE REFERRED TO OUR INSTITUTION, 5 WEEKS AFTER EVAR, FOR AN OPINION ON FURTHER MANAGEMENT. REPEAT CT SCANNING AT THIS TIME DEMONSTRATED NO LOSS IN KIDNEY SIZE, WITH CORTICAL ENHANCEMENT, PRESUMABLY FROM COLLATERAL SUPPLY. A DECISION WAS MADE TO PROCEED WITH SURGICAL REVASCULARIZATION IN THE HOPE OF REESTABLISHING ADEQUATE RENAL PERFUSION AND REVERSING THE NEED FOR RENAL SUPPORT. HEPATORENAL AND SPLENORENAL BYPASSES WERE PERFORMED THROUGH A BILATERAL SUBCOSTAL INCISION. WITH A LEFT MEDIAL VISCERAL ROTATION, THE SPLENIC ARTERY WAS DISSECTED, LIGATED, AND ANASTOMOSED TO THE LEFT RENAL ARTERY IN AN END-TO-SIDE MANNER. THE RIGHT RENAL ARTERY WAS EXPOSED AFTER MOBILIZATION OF THE RIGHT COLON AND DUODENUM. A REVERSED LONG SAPHENOUS VEIN GRAFT HARVESTED FROM THE LEFT THIGH WAS USED AS A CONDUIT GRAFT FROM THE COMMON HEPATIC ARTERY TO THE RIGHT RENAL ARTERY, AGAIN IN AN END-TO-SIDE MANNER. THE PATIENT STARTED PASSING URINE ON DAY 5 POSTOPERATIVELY, HE NO LONGER REQUIRED HEMOFILTRATION BY DAY 8, AND WAS SUBSEQUENTLY DISCHARGED, WITH A CREATININE LEVEL OF 122 MMOL/L. AT 3-YEARS FOLLOW-UP AFTER THE PROCEDURE, HIS CREATININE LEVEL REMAINED WITHIN NORMAL LIMITS, AND FOLLOW-UP IMAGING REVEALED NO ENDOLEAK OR INCREASE IN SAC SIZE. ANN VASC SURG 2012; 26: 1127.E1E1127.E7
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALENT AAA STENT GRAFT SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC CARDIOVASCULAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Required Intervention |