ENDURANT
Report
- Report Number
- 2953200-2013-02021
- Event Type
- Death
- Date Received
- October 18, 2013
- Date of Event
- December 6, 2013
- Report Date
- December 9, 2013
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
Narratives
EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION). (UNKNOWN CAUSE OF EVENT). CONCLUSION: (UNKNOWN CAUSE OF EVENT). (B)(4).
(B)(4). RESULTS, CONCLUSION: ANATOMY RELATED; HYPERCOAGULABILITY.
METHOD: FILM.
METHOD: FILM. RESULTS, CONCLUSION: UNKNOWN CAUSE OF DEATH. PATIENT CONDITION; THROMBUS MAY HAVE BEEN DUE TO HYPERCOAGULABILITY.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE INVESTIGATOR ASSESSED THE DEATH AS DEVICE AND PROCEDURE RELATED. FILM REVIEW ANALYSIS: CTA 3-YEARS POST-IMPLANT REVEALED THAT THE BIFUR WAS PLACED JUST BELOW THE RENALS, INTO A VERY SHORT LENGTH NECK. THE IPSILATERAL LIMB AND EXTENSION WAS POSITIONED WITHIN THE LEFT COMMON ILIAC, AND THE CONTRALATERAL AND EXTENSION WAS IN THE RIGHT COMMON ILIAC. THE AAA WAS BI-LOBAL; THE PROXIMAL MAX ANEURYSM DIAMETER WAS 5.5CM AND THE DISTAL MAX AAA DIAMETER WAS 10CM. AREAS OF THROMBUS WAS SEEN WITHIN THE DESCENDING THORACIC AORTA, AND WITHIN THE THORACO-ABDOMINAL AORTA. THE ENTIRE STENT GRAFT SYSTEM WAS SEEN PARTIALLY OCCLUDED BY THROMBUS. BEGINNING AT THE PROXIMAL STENT GRAFT MARGIN, THE BIFUR AORTIC BODY WAS APPROXIMATELY 50 PERCENT OCCLUDED DOWN TO THE FLOW DIVIDER, AND BOTH LIMBS/EXTENSIONS SHOWED AREAS OF THROMBUS ALONG THEIR ENTIRE LENGTH; PRIMARILY SEEN ALONG THE INNER WALL OF THE STENT GRAFTS. NEAR TO THE ORIGIN OF THE LIMBS, BOTH THE IPSI AND CONTRA LIMBS WERE ANGULATED POST APPROXIMATELY 70 DEGREE; BUT NO OBVIOUS KINKS OR LIMB COMPRESSION WAS SEEN. PRE-IMPLANT AND EARLIER POST-IMPLANT FILMS WERE NOT PROVIDED. THE CAUSE OF THE THORACIC AORTA AND WIDESPREAD STENT GRAFT THROMBUS COULD NOT BE DETERMINED AND MAY BE RELATED TO A PATIENT CONDITION (HYPERCOAGULABILITY). CTA AT 3 YEARS POST-IMPLANT, 1 WEEK AFTER THE REPORTED RESOLUTION OF THE THROMBUS USING ANTICOAGULANTS, REVEALED SIMILAR FINDINGS FROM THE STUDY 1-MONTH PRIOR. THE BI-LOBAL AAA DIAMETER MEASURED 5.9 CM MAX (PROXIMAL ANEURYSM) AND 11 CM MAX (DISTAL AAA); SLIGHTLY INCREASED FROM PREVIOUS STUDY. AGAIN, THROMBUS WAS SEEN WITHIN THE BIFURCATE AORTIC BODY AND ALONG THE LENGTH OF BOTH LIMBS. NO OBVIOUS STENT GRAFT KINKS OR COMPRESSION WAS SEEN. THE CAUSE OF THE THROMBUS COULD NOT BE DETERMINED AND MAY BE PATIENT RELATED, AND NO STENT GRAFT RELATED ISSUES TO THE PATIENT'S DEATH COULD BE DETERMINED.
AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 110 MM IN DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM. LENGTH OF NON-ANEURYSM AORTIC NECK WAS 15 MM, PROXIMAL DIAMETER OF NON-ANEURYSM AORTIC NECK WAS 24 MM, DISTAL DIAMETER OF NON-ANEURYSMAL AORTIC NECK WAS 25 MM, DIAMETER OF RIGHT ILIAC ARTERY WAS 13 MM, DIAMETER OF LEFT ILIAC ARTERY WAS 9 MM, DIAMETER OF RIGHT FEMORAL ARTERY WAS 12 MM, AND DIAMETER OF LEFT FEMORAL ARTERY WAS 10 MM. THE RIGHT ILIAC ARTERY WAS MILDLY TORTUOUS AND THE LEFT ILIAC ARTERY WAS MODERATELY TORTUOUS. DEGREE OF CIRCUMFERENTIAL THROMBUS AND / OR CALCIFICATION WAS 30%. IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED DUE TO ABDOMINAL PAIN. A CTA SCAN SHOWED THROMBUS IN THE ABDOMINAL AORTA. THE PATIENT WAS TREATED WITH ANTICOAGULANTS RESOLVING THE EVENT. THE PHYSICIAN ASSESSED THIS EVENT AS NOT DEVICE OR PROCEDURE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.
FILM REVIEW ANALYSIS: CTA IMAGES 3-YEARS POST-IMPLANT REVEALED THAT THE BIFURCATE WAS PLACED JUST BELOW THE RENALS, INTO A VERY SHORT LENGTH NECK. THE IPSILATERAL LIMB AND EXTENSION WAS POSITIONED WITHIN THE LEFT COMMON ILIAC, AND THE CONTRA LIMB AND EXTENSION WAS IN THE RIGHT COMMON ILIAC. THE AAA WAS BI-LOBAL; THE PROXIMAL MAX ANEURYSM DIAMETER WAS 5.5CM AND THE DISTAL MAX AAA DIAMETER WAS 10CM. AREAS OF THROMBUS WAS SEEN WITHIN THE DESCENDING THORACIC AORTA, AND WITHIN THE THORACO-ABDOMINAL AORTA. THE ENTIRE STENT GRAFT SYSTEM WAS SEEN PARTIALLY OCCLUDED BY THROMBUS. BEGINNING AT THE PROXIMAL STENT GRAFT MARGIN, THE BIFURCATE AORTIC BODY WAS APPROXIMATELY 50% OCCLUDED DOWN TO THE FLOW DIVIDER, AND BOTH LIMBS/EXTENSIONS SHOWED AREAS OF THROMBUS ALONG THEIR ENTIRE LENGTH; PRIMARILY SEEN ALONG THE INNER WALL OF THE STENT GRAFTS. NEAR TO THE ORIGIN OF THE LIMBS, BOTH THE IPSI AND CONTRA LIMBS WERE ANGULATED POSTERIORLY APPROXIMATELY 70DEG; BUT NO OBVIOUS KINKS OR LIMB COMPRESSION WAS SEEN. PRE-IMPLANT AND EARLIER POST-IMPLANT FILMS WERE NOT PROVIDED. THE CAUSE OF THE THORACIC AORTA AND WIDESPREAD STENT GRAFT THROMBUS COULD NOT BE DETERMINED AND MAY BE RELATED TO A PATIENT CONDITION (HYPERCOAGULABILITY).
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE LOCATION OF THE THROMBUS WAS LOCATED IN THE ABDOMINAL AORTA AND INSIDE THE STENT GRAFT. THE OCCLUSION/THROMBUS LOCATED IN CORONARY AND IN THE AORTA AS INDICATED IN THE CT CANNOT BE DEVICE RELATED AND PROBABLY DERIVES FROM HYPERCOAGULABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535388 | ENDURANT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V00508961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Death| R |