ENDURANT BIFURCATED STENT GRAFT
Report
- Report Number
- 9612164-2023-00162
- Event Type
- Injury
- Date Received
- January 12, 2023
- Date of Event
- March 3, 2022
- Report Date
- January 19, 2023
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; A CASE OF BILATERAL AORTOILIAC ANEURYSM WITH PERSISTENT ANEURYSMAL SCIATIC ARTERY TREATED BY ENDOVASCULAR ANEURYSM REPAIR XIAO J, LIN S, ZHOU Y, AI W, LI Y, LI Q, ZHANG Z. ANN VASC SURG. 2022 AUG;84:406.E1-406.E6. DOI: 10.1016/J.AVSG.2022.02.003. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
B5; ADDITIONAL INFORMATION RECEIVED: THE REASON FOR TYPE IA ENDOLEAK WAS THAT THE ANCHORING AREA WAS INSUFFICIENT. THE INFRARENAL ANCHORING AREA WAS LESS THAN 0.5 CM IN THE FIRST SURGERY, AND THE NECK OF THE FIRST ANEURYSM WAS DISTORTED. IN THE SECOND SURGERY, SPRING COIL PACKING WAS PERFORMED IN THE TUMOR BODY. IN THE THIRD SURGERY, A CUFF AND DOUBLE RENAL CHIMNEYS WERE ADDED, AND SPRING COIL AND PROTHROMBIN COMPLEX WERE ADDED. FINALLY, THE ENDOLEAK DISAPPEARED. A 3 YEAR FOLLOW-UP VISIT HAS BEEN CONDUCTED SINCE AND THE PATIENT IS ALIVE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A PATIENT WAS DIAGNOSED WITH A 52MM INFRARENAL ABDOMINAL AORTIC ANEURYSM , BILATERAL COMMON ILIAC ANEURYSM WITH A DIAMETER OF 39 MM FOR BOTH SIDES. THE PATIENT ALSO HAD A RIGHT ANEURYSMAL PERSISTENT SCIATIC ARTERY (PSA) WITH A DIAMETER OF 14MM. THE DISTAL RIGHT INTERNAL ILIAC ARTERY WAS CONNECTED TO A PSA, WHICH EXTENDED DOWN TO THE POPLITEAL ARTERY AND WAS THE MAIN BLOOD SUPPLY OF THE LOWER LIMB. THE RIGHT FEMORAL ARTERY AND THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS ATROPHIC WITH A DIAMETER OF 7.8 MM AND 3.2 MM, RESPECTIVELY, AND THE CONTRALATERAL LEFT FEMORAL ARTERY AND THE LEFT SUPERFICIAL FEMORAL ARTERY WAS NORMAL IN CALIBER WITH A DIAMETER OF 10.9 MM AND 6.6 MM, RESPECTIVELY. INTERVENTION WAS PERFORMED UNDER GENERAL ANESTHESIA , A 6F SHEATH WAS INSERTED FROM THE RIGHT COMMON FEMORAL ARTERY INTO THE LEFT INTERNAL ILIAC ARTERY, FOLLOWED BY EMBOLIZATION WITH THREE NON MDT COILS. AN ENDURANT BIFURCATE WAS WAS INSERTED FROM THE RIGHT PERSISTENT SCIATIC ARTERY AND DEPLOYED BELOW THE RENAL ARTERIES. AN ILIAC BIFURCATED SIDE BRANCH DEVICE (IBD) WITH A COVERED STENT AND A HALF CUT OFF NON MDT STENT WAS HANDMADE IN VITRO. THE IBD WAS INSERTED FROM THE LEFT FEMORAL ARTERY, WITH ITS 25 MM BRANCHED STENT DELIVERED IN THE ABDOMINAL AORTIC ANEURYSM, PROXIMAL END PLACED IN THE CONTRALATERAL LEG OF THE ENDURANT AORTOILIAC DEVICE, AND DISTAL END PLACED IN LEFT ILIAC ARTERY CONNECTED WITH A NON MDT COVERED STENT LANDING IN THE LEFT EXTERNAL ILIAC ARTERY. A NON MDT GUIDEWIRE WAS INSERTED FROM THE LEFT BRACHIAL ARTERY, SELECTED INTO THE RIGHT COMMON ILIAC ANEURYSM THROUGH BRANCHED STENT OF IBD, AND CAPTURED OUT OF ARTERY THROUGH RIGHT FEMORAL ACCESS BY A CAPTURE DEVICE. A BARE METAL STENT WAS CONNECTED WITH THE BRANCHED STENT OF IBD. THEN THE IPSILATERAL LIMB OF THE AORTOILIAC DEVICE WAS DELIVERED THROUGH THE RIGHT COMMON AND INTERNAL ILIAC ARTERY AND EXTENDED WITH THREE MEDTRONIC COVERED STENTS 16E16E120 MM, 16E13E120 MM, AND 16E16E95 MM LANDING IN THE RIGHT PERSISTENT SCIATIC ARTERY AT THE LEVEL OF THE FEMORAL HEAD. AFTER BALLOON DILATATION, THE INFRARENAL ABDOMINAL AORTIC ANEURYSM, BILATERAL COMMON-INTERNAL ILIAC ANEURYSM, AND RIGHT PERSISTENT SCIATIC ARTERY ANEURYSM WERE ALL ISOLATED, AND NO ENDOLEAKS WERE NOTED ON COMPLETION ANGIOGRAPHY. THE TOTAL OPERATIVE TIME AS 4 HOURS, 55 MINS. ONE MONTH POSTOPERATIVELY, A CTA REVEALED A TYPE 1 ENDOLEAK ORIGINATING FROM THE PROXIMAL END OF THE AORTA GRAFT. RE-INTERVENTION WAS PERFORMED TO EMBOLIZE THE ENDOLEAK WITH 2 X 10 MM INTERLOCKING DETACHABLE COILS, 4 X12 MM INTERLOCKING DETACHABLE COILS, AND 3 X14 MM INTERLOCKING DETACHABLE COILS (NON MDT) ; HOWEVER, THE ENDOLEAK STILL EXISTED, AND THE ANEURYSM DID NOT SHRINK SIGNIFICANTLY ON CTA PERFORMED 3 AND 12 MONTHS AFTER THE SECOND OPERATION. THE 3RD INTERVENTION WAS PERFORMED BY EXTENDING WITH A 32- 45MM MEDTRONIC CUFF AT THE PROXIMAL END OF THE GRAFT WITH BILATERAL CHIMNEY RENAL STENTS . BARE METAL STENT (NON MDT) WERE INSERTED INTO THE LEFT AND RIGHT RENAL ARTERY. THE SAC WAS EMBOLIZED WITH 9 X 20-40 MM MM INTERLOCKING DETACHABLE COILS AND 12 ML FIBRIN SEALANT (NON MDT). THE TYPE I ENDOLEAK WAS CLOSED ON THE COMPLETION OF ANGIOGRAPHY AND CTA 2 MONTHS AFTER THE THIRD OPERATION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1565099 | ENDURANT BIFURCATED STENT GRAFT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR | MIH | MEDTRONIC IRELAND | ENBF2813C170EE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Required Intervention |