INCRAFT
Report
- Report Number
- 9616099-2024-00098
- Event Type
- Injury
- Date Received
- March 30, 2024
- Date of Event
- December 30, 2022
- Report Date
- April 23, 2024
- Manufacturer
- CORDIS CASHEL
- Product Code
- MIH
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
KIM, Y., YUN, W.-S., & KIM, H.-K. (2022, DECEMBER 30). LATE TYPE IIIB ENDOLEAK AFTER LOW-PROFILE ENDOGRAFT IMPLANTATION FOR ABDOMINAL AORTIC ANEURYSM TREATED BY HYBRID SURGERY. VASCULAR SPECIALIST INTERNATIONAL. HTTPS://WWW.VSIJOURNAL.ORG/JOURNAL/VIEW.HTML?DOI=10.5758%2FVSI.220055. LOT AND CATALOG WILL REMAIN UNKNOWN AS NO FURTHER INFORMATION WAS PROVIDED. AS REPORTED IN THE LITERATURE ARTICLE BY KIM Y, YUN WS, KIM HK. LATE TYPE IIIB ENDOLEAK AFTER LOW-PROFILE ENDOGRAFT IMPLANTATION FOR ABDOMINAL AORTIC ANEURYSM TREATED BY HYBRID SURGERY. VASC SPECIALIST INT. (2022) ONE PATIENT PRESENTED WITH A IIIB ENDOLEAK ON COMPUTED TOMOGRAPHY (CT) APPROXIMATELY THREE YEARS AFTER ENDOVASCULAR ANEURYSM REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM WITH A LOW PROFILE 30MM INCRAFT STENT GRAFT. THE CT PRESENTED SAC ENLARGEMENT WITH A LARGE AMOUNT OF PERIGRAFT ENDOLEAK, AND AN URGENT ENDOVASCULAR REPAIR WAS PERFORMED. A NON-CORDIS ENDOGRAFT WAS DEPLOYED TO COVER THE ENTIRE STENT GRAFT, FOLLOWED WITH EMBOLIZATION OF THE RIGHT LIMB AND FEMORO-FEMORAL BYPASS. FINAL ANGIOGRAPHY REVEALED NO ENDOLEAK, AND FOLLOW-UP IMAGES REVEALED SAC SHRINKAGE WITHOUT ENDOLEAK. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT IS AN IMPLANTED DEVICE. THE REPORTED ¿BIFURCATED AORTIC PROSTHESIS ENDOLEAK TYPE IIIB¿, WAS CONFIRMED AS CT IMAGES WERE PROVIDED FOR REVIEW IN THE ARTICLE. HOWEVER, THE EXACT CAUSE COULD NOT BE DETERMINED. ANGIOGRAPHY REVEALED AN ENDOLEAK JETTING FROM THE LEFT SIDE OF THE MAIN BODY BUT NO EVIDENCE OF IA ENDOLEAK. HOWEVER, A NEW ENDOGRAFT WAS DEPLOYED COVING THE ENTIRE GRAFT ALONG WITH EMBOLIZATION OF THE RIGHT LIMB AND FEMORO-FEMORAL BYPASS. FINAL ANGIOGRAPHY REVEALED NO ENDOLEAK, AND FOLLOW-UP IMAGES REVEALED SAC SHRINKAGE WITHOUT ENDOLEAK. TYPE III ENDOLEAKS HAVE COMMONLY BEEN REPORTED AS A RESULT OF MODULAR COMPONENT SEPARATION. THESE ENDOLEAKS ARE DUE TO LEAKAGE THROUGH A DEFECT IN THE GRAFT FABRIC OR BETWEEN THE SEGMENTS OF A MODULAR, MULTISEGMENTAL GRAFT. THIS SUBGROUP IS DUE TO MECHANICAL FAILURE OF THE GRAFT. WHEN THERE IS LEAKAGE OF BLOOD THROUGH THE BODY OF A STENT-GRAFT, A TYPE III ENDOLEAK RESULTS. THIS ENDOLEAK IS RELATED TO POOR APPOSITION OR SEPARATION OF THE COMPONENTS OF THE STENT-GRAFT, OR IT CAN BE DUE TO RUPTURE OR TEAR OF THE GRAFT MATERIAL. LIKE TYPE I ENDOLEAKS, TYPE III ENDOLEAKS ARE CONSIDERED HIGH-PRESSURE, HIGH-RISK LEAKS AND REQUIRE URGENT MANAGEMENT [2]. TYPE III ENDOLEAKS ALSO ARE OFTEN ASSOCIATED WITH MEASURABLE INCREASES IN ANEURYSM SAC SIZE. TYPE III ENDOLEAKS MANIFEST AS COLLECTIONS OF HEMORRHAGE OR CONTRAST MATERIAL CENTRALLY WITHIN THE ANEURYSM SAC, USUALLY DISTANT FROM THE ATTACHMENT SITES WITH THE NATIVE VESSELS [6]. THESE ARE FREQUENTLY LARGE COLLECTIONS THAT OPACIFY DENSELY WITH CONTRAST. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿THE INCRAFT® STENT-GRAFT SYSTEM IS INTENDED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS WITH THE FOLLOWING CHARACTERISTICS: FEMORAL ACCESS VESSELS SHOULD BE ADEQUATE TO FIT THE SELECTED DELIVERY SYSTEM; PROXIMAL NECK LENGTH = 10MM; AORTIC NECK DIAMETERS = 17MM AND = 31MM; AORTIC NECK SUITABLE FOR SUPRARENAL FIXATION; INFRARENAL AND SUPRARENAL NECK ANGULATION = 60°; ILIAC FIXATION LENGTH = 15MM; ILIAC DIAMETERS = 7MM AND = 22MM; MINIMUM OVERALL AAA TREATMENT LENGTH (PROXIMAL LANDING LOCATION TO DISTAL LANDING LOCATION) = 128MM; MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR POTENTIAL ADVERSE EVENTS AND POTENTIAL DEVICE RISKS INCLUDE, BUT ARE NOT LIMITED TO: EXPECTED CLINICAL ADVERSE EVENTS; ARTERIAL OR VENOUS THROMBOSIS, ENDOLEAK, SURGICAL CONVERSION TO OPEN SURGERY. EXPECTED POTENTIAL RISKS ASSOCIATED WITH THE STENT GRAFT SYSTEM: COMPONENT MIGRATION, GRAFT PUNCTURE, INCOMPLETE COMPONENT DEPLOYMENT, INSERTION AND REMOVAL DIFFICULTIES, PERIGRAFT FLOW. WHEN ADVANCING THE GUIDEWIRES, CATHETERS, AND THE INCRAFT® AAA STENT-GRAFT SYSTEM INTO THE ABDOMINAL AORTA, DO NOT DISTURB THE THROMBUS MASS WITHIN THE ANEURYSM. DOING SO MAY DISLODGE EMBOLI, WHICH CAN CAUSE DISTAL EMBOLIZATION. IF DISTAL EMBOLIZATION SHOULD OCCUR, USE CONVENTIONAL TREATMENT METHODS. CAUTION: BE CAREFUL NOT TO DISPLACE THE PROSTHESES UPON INTRODUCING AND RETRACTING THE BALLOON CATHETER. NOTE: CARE SHOULD BE TAKEN WHEN INFLATING THE BALLOON, ESPECIALLY WITH CALCIFIED, TORTUOUS, STENOTIC, OR OTHERWISE DISEASED VESSELS. ENSURE TO NOT INFLATE THE BALLOON OUTSIDE OR THE GRAFT MATERIAL. INFLATE BALLOON SLOWLY. IT IS RECOMMENDED THAT A BACKUP BALLOON BE AVAILABLE. WARNINGS: OVER INFLATION OF BALLOON CAN CAUSE GRAFT TEARS AND/OR VESSEL DISSECTION OR RUPTURE. CAUTIONS: LEAKS AT THE ATTACHMENT OR CONNECTION SITES SHOULD BE TREATED USING A BALLOON CATHETER TO REMODEL THE PROSTHESIS AGAINST THE VESSEL WALL. MAJOR LEAKS THAT CANNOT BE CORRECTED BY EITHER RE-BALLOONING MAY BE TREATED BY ADDING AORTIC OR ILIAC EXTENSION COMPONENTS TO THE PREVIOUSLY PLACED STENT-GRAFT COMPONENTS OR ANY OTHER METHOD PER LOCAL PRACTICE AND THE CLINICAL SITUATION.¿ BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
KIM, Y., YUN, W.-S., & KIM, H.-K. (2022, DECEMBER 30). LATE TYPE IIIB ENDOLEAK AFTER LOW-PROFILE ENDOGRAFT IMPLANTATION FOR ABDOMINAL AORTIC ANEURYSM TREATED BY HYBRID SURGERY. VASCULAR SPECIALIST INTERNATIONAL. HTTPS://WWW.VSIJOURNAL.ORG/JOURNAL/VIEW.HTML?DOI=10.5758%2FVSI.220055. LOT AND CATALOG WILL REMAIN UNKNOWN AS NO FURTHER INFORMATION WAS PROVIDED. AS REPORTED IN THE LITERATURE ARTICLE BY KIM Y, YUN WS, KIM HK. LATE TYPE IIIB ENDOLEAK AFTER LOW-PROFILE ENDOGRAFT IMPLANTATION FOR ABDOMINAL AORTIC ANEURYSM TREATED BY HYBRID SURGERY. VASC SPECIALIST INT. (2022) ONE PATIENT PRESENTED WITH A 111B ENDOLEAK ON COMPUTED TOMOGRAPHY (CT) APPROXIMATELY THREE YEARS AFTER ENDOVASCULAR ANEURYSM REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM WITH A LOW PROFILE 30MM INCRAFT STENT GRAFT. THE CT PRESENTED SAC ENLARGEMENT WITH A LARGE AMOUNT OF PERIGRAFT ENDOLEAK, AND AN URGENT ENDOVASCULAR REPAIR WAS PERFORMED. A NON-CORDIS ENDOGRAFT WAS DEPLOYED TO COVER THE ENTIRE STENT GRAFT, FOLLOWED WITH EMBOLIZATION OF THE RIGHT LIMB AND FEMORO-FEMORAL BYPASS. FINAL ANGIOGRAPHY REVEALED NO ENDOLEAK, AND FOLLOW-UP IMAGES REVEALED SAC SHRINKAGE WITHOUT ENDOLEAK. THERE WAS CORDIS TRAINING/CLINICAL PERSONNEL PRESENT FOR PHYSICIAN ADVICE/SUPPORT. THE PATIENT WAS SELECTED APPROPRIATELY, PER THE PARAMETERS STATED IN THE IFU. THE ENDOLEAK WAS CAUSED 3 YEARS LATER, TYPE IIIB MAINBODY BIFURCATE BETWEEN PROXIMAL LEG GRAFT. THERE WAS NO DEVICE MIGRATION. A NON-CORDIS ENDOGRAFT WAS INSERTED TO RESCUE THE IMPLANTATION. THERE WAS NO ADDITIONAL BALLOON MOLDING REQUIRED. THE STATUS OF THE PATIENT IS UNKNOWN AS THE PATIENT DOES NOT VISIT THE HOSPITAL. THE USER IS TRAINED TO THE DEVICE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT IS AN IMPLANTED DEVICE. THE REPORTED ¿BIFURCATED AORTIC PROSTHESIS ENDOLEAK TYPE IIIB¿, WAS CONFIRMED AS CT IMAGES WERE PROVIDED FOR REVIEW IN THE ARTICLE. HOWEVER, THE EXACT CAUSE COULD NOT BE DETERMINED. ANGIOGRAPHY REVEALED AN ENDOLEAK JETTING FROM THE LEFT SIDE OF THE MAIN BODY BUT NO EVIDENCE OF IA ENDOLEAK. HOWEVER, A NEW ENDOGRAFT WAS DEPLOYED COVING THE ENTIRE GRAFT ALONG WITH EMBOLIZATION OF THE RIGHT LIMB AND FEMORO-FEMORAL BYPASS. FINAL ANGIOGRAPHY REVEALED NO ENDOLEAK, AND FOLLOW-UP IMAGES REVEALED SAC SHRINKAGE WITHOUT ENDOLEAK. TYPE III ENDOLEAKS HAVE COMMONLY BEEN REPORTED AS A RESULT OF MODULAR COMPONENT SEPARATION. THESE ENDOLEAKS ARE DUE TO LEAKAGE THROUGH A DEFECT IN THE GRAFT FABRIC OR BETWEEN THE SEGMENTS OF A MODULAR, MULTISEGMENTAL GRAFT. THIS SUBGROUP IS DUE TO MECHANICAL FAILURE OF THE GRAFT. WHEN THERE IS LEAKAGE OF BLOOD THROUGH THE BODY OF A STENT-GRAFT, A TYPE III ENDOLEAK RESULTS. THIS ENDOLEAK IS RELATED TO POOR APPOSITION OR SEPARATION OF THE COMPONENTS OF THE STENT-GRAFT, OR IT CAN BE DUE TO RUPTURE OR TEAR OF THE GRAFT MATERIAL. LIKE TYPE I ENDOLEAKS, TYPE III ENDOLEAKS ARE CONSIDERED HIGH-PRESSURE, HIGH-RISK LEAKS AND REQUIRE URGENT MANAGEMENT [2]. TYPE III ENDOLEAKS ALSO ARE OFTEN ASSOCIATED WITH MEASURABLE INCREASES IN ANEURYSM SAC SIZE. TYPE III ENDOLEAKS MANIFEST AS COLLECTIONS OF HEMORRHAGE OR CONTRAST MATERIAL CENTRALLY WITHIN THE ANEURYSM SAC, USUALLY DISTANT FROM THE ATTACHMENT SITES WITH THE NATIVE VESSELS [6]. THESE ARE FREQUENTLY LARGE COLLECTIONS THAT OPACIFY DENSELY WITH CONTRAST. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿THE INCRAFT® STENT-GRAFT SYSTEM IS INTENDED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS WITH THE FOLLOWING CHARACTERISTICS: FEMORAL ACCESS VESSELS SHOULD BE ADEQUATE TO FIT THE SELECTED DELIVERY SYSTEM; PROXIMAL NECK LENGTH = 10MM; AORTIC NECK DIAMETERS = 17MM AND = 31MM; AORTIC NECK SUITABLE FOR SUPRARENAL FIXATION; INFRARENAL AND SUPRARENAL NECK ANGULATION = 60°; ILIAC FIXATION LENGTH = 15MM; ILIAC DIAMETERS = 7MM AND = 22MM; MINIMUM OVERALL AAA TREATMENT LENGTH (PROXIMAL LANDING LOCATION TO DISTAL LANDING LOCATION) = 128MM; MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR POTENTIAL ADVERSE EVENTS AND POTENTIAL DEVICE RISKS INCLUDE, BUT ARE NOT LIMITED TO: EXPECTED CLINICAL ADVERSE EVENTS; ARTERIAL OR VENOUS THROMBOSIS, ENDOLEAK, SURGICAL CONVERSION TO OPEN SURGERY. EXPECTED POTENTIAL RISKS ASSOCIATED WITH THE STENT GRAFT SYSTEM: COMPONENT MIGRATION, GRAFT PUNCTURE, INCOMPLETE COMPONENT DEPLOYMENT, INSERTION AND REMOVAL DIFFICULTIES, PERIGRAFT FLOW. WHEN ADVANCING THE GUIDEWIRES, CATHETERS, AND THE INCRAFT® AAA STENT-GRAFT SYSTEM INTO THE ABDOMINAL AORTA, DO NOT DISTURB THE THROMBUS MASS WITHIN THE ANEURYSM. DOING SO MAY DISLODGE EMBOLI, WHICH CAN CAUSE DISTAL EMBOLIZATION. IF DISTAL EMBOLIZATION SHOULD OCCUR, USE CONVENTIONAL TREATMENT METHODS. CAUTION: BE CAREFUL NOT TO DISPLACE THE PROSTHESES UPON INTRODUCING AND RETRACTING THE BALLOON CATHETER. NOTE: CARE SHOULD BE TAKEN WHEN INFLATING THE BALLOON, ESPECIALLY WITH CALCIFIED, TORTUOUS, STENOTIC, OR OTHERWISE DISEASED VESSELS. ENSURE TO NOT INFLATE THE BALLOON OUTSIDE OR THE GRAFT MATERIAL. INFLATE BALLOON SLOWLY. IT IS RECOMMENDED THAT A BACKUP BALLOON BE AVAILABLE. WARNINGS: OVER INFLATION OF BALLOON CAN CAUSE GRAFT TEARS AND/OR VESSEL DISSECTION OR RUPTURE. CAUTIONS: LEAKS AT THE ATTACHMENT OR CONNECTION SITES SHOULD BE TREATED USING A BALLOON CATHETER TO REMODEL THE PROSTHESIS AGAINST THE VESSEL WALL. MAJOR LEAKS THAT CANNOT BE CORRECTED BY EITHER RE-BALLOONING MAY BE TREATED BY ADDING AORTIC OR ILIAC EXTENSION COMPONENTS TO THE PREVIOUSLY PLACED STENT-GRAFT COMPONENTS OR ANY OTHER METHOD PER LOCAL PRACTICE AND THE CLINICAL SITUATION.¿ BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AS REPORTED IN THE LITERATURE ARTICLE BY KIM Y, YUN WS, KIM HK. LATE TYPE IIIB ENDOLEAK AFTER LOW-PROFILE ENDOGRAFT IMPLANTATION FOR ABDOMINAL AORTIC ANEURYSM TREATED BY HYBRID SURGERY. VASC SPECIALIST INT. (2022) ONE PATIENT PRESENTED WITH A 111B ENDOLEAK ON COMPUTED TOMOGRAPHY (CT) APPROXIMATELY THREE YEARS AFTER ENDOVASCULAR ANEURYSM REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM WITH A LOW PROFILE 30MM INCRAFT STENT GRAFT. THE CT PRESENTED SAC ENLARGEMENT WITH A LARGE AMOUNT OF PERIGRAFT ENDOLEAK, AND AN URGENT ENDOVASCULAR REPAIR WAS PERFORMED. A NON-CORDIS ENDOGRAFT WAS DEPLOYED TO COVER THE ENTIRE STENT GRAFT, FOLLOWED WITH EMBOLIZATION OF THE RIGHT LIMB AND FEMORO-FEMORAL BYPASS. FINAL ANGIOGRAPHY REVEALED NO ENDOLEAK, AND FOLLOW-UP IMAGES REVEALED SAC SHRINKAGE WITHOUT ENDOLEAK. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT IS AN IMPLANTED DEVICE.
AS REPORTED IN THE LITERATURE ARTICLE BY KIM Y, YUN WS, KIM HK. LATE TYPE IIIB ENDOLEAK AFTER LOW-PROFILE ENDOGRAFT IMPLANTATION FOR ABDOMINAL AORTIC ANEURYSM TREATED BY HYBRID SURGERY. VASC SPECIALIST INT. (2022) ONE PATIENT PRESENTED WITH A 111B ENDOLEAK ON COMPUTED TOMOGRAPHY (CT) APPROXIMATELY THREE YEARS AFTER ENDOVASCULAR ANEURYSM REPAIR FOR AN ABDOMINAL AORTIC ANEURYSM WITH A LOW PROFILE 30MM INCRAFT STENT GRAFT. THE CT PRESENTED SAC ENLARGEMENT WITH A LARGE AMOUNT OF PERIGRAFT ENDOLEAK, AND AN URGENT ENDOVASCULAR REPAIR WAS PERFORMED. A NON-CORDIS ENDOGRAFT WAS DEPLOYED TO COVER THE ENTIRE STENT GRAFT, FOLLOWED WITH EMBOLIZATION OF THE RIGHT LIMB AND FEMORO-FEMORAL BYPASS. FINAL ANGIOGRAPHY REVEALED NO ENDOLEAK, AND FOLLOW-UP IMAGES REVEALED SAC SHRINKAGE WITHOUT ENDOLEAK. THERE WAS CORDIS TRAINING/CLINICAL PERSONNEL PRESENT FOR PHYSICIAN ADVICE/SUPPORT. THE PATIENT WAS SELECTED APPROPRIATELY, PER THE PARAMETERS STATED IN THE IFU. THE ENDOLEAK WAS CAUSED 3 YEARS LATER, TYPE IIIB MAINBODY BIFURCATE BETWEEN PROXIMAL LEG GRAFT. THERE WAS NO DEVICE MIGRATION. A NON-CORDIS ENDOGRAFT WAS INSERTED TO RESCUE THE IMPLANTATION. THERE WAS NO ADDITIONAL BALLOON MOLDING REQUIRED. THE STATUS OF THE PATIENT IS UNKNOWN AS THE PATIENT DOES NOT VISIT THE HOSPITAL. THE USER IS TRAINED TO THE DEVICE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT IS AN IMPLANTED DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2583924 | INCRAFT | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | CORDIS CASHEL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention| H| L | ENDURANT II MEDTRONIC.| UNKNOWN NON-CORDIS ENDOGRAFT.| VASCULAR PLUGS AMPLATZER ABBOTT. |