AFX2 Bifurcated Endograft System BEA22-70/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00818009015143), received between Nov 15, 2016 and Jun 26, 2025 — classified as 3 deaths, 23 injuries.

The most frequently reported specific device problem is “Off-Label Use” (7 reports).

16 other recalls cover devices cleared under the same FDA submission (P040002); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Migration or Expulsion of Device; Separation Problem; Migration or Expulsion of Device; Separation Problem

  THE PATIENT WAS TREATED WITH ENDOVASCULAR ANEURYSM REPAIR (EVAR) USING THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL ON. ROUTINE COMPUTED TOMOGRAPHY (CT) SCAN FOLLOW-UPS WERE CONDUCTED. APPROXIMATELY SIX (6) YEARS AFTER THE INITIAL PROCEDURE, IT WAS REPORTED THAT THE AFX2 BIFURCATED STENT GRAFT AND THE AFX VELA SUPRARENAL HAD MIGRATED VENTRALLY, RESULTING IN REDUCED OVERLAP LENGTH AND INCREASED AORTIC ANGULATION. DESPITE THE MIGRATION, THE PROXIMAL AND DISTAL ANCHORING POINTS REMAINED STABLE. THE MIGRATION APPEARED TO HAVE LED TO A TYPE IIIA ENDOLEAK DUE TO SEPARATION BETWEEN THE DEVICES. OPEN SURGICAL REPAIR WAS PERFORMED USING A NON-ENDOLOGIX ARTIFICIAL GRAFT. THE DISTALLY PLACED AFX2 BIFURCATED STENT GRAFT WAS FULLY REMOVED, WHILE THE PROXIMALLY PLACED AFX VELA SUPRARENAL WAS PARTIALLY CUT AND ANASTOMOSED TO THE ARTIFICIAL VESSEL (THE EXCISED PORTION WAS FULLY REMOVED). THE PATIENT RECOVERED AND WAS DISCHARGED IN GOOD CONDITION.

  Patient problems: Clinical Endoleak

  MAUDE report 22341543 ↗
• InjuryJun 11, 2025Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE PATIENT WAS TREATED WITH ENDOVASCULAR ANEURISM REPAIR (EVAR) FOR A FUSIFORM ANEURYSM WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA INFRARENAL, AND A GORE CUFF 26-33MM (NON-ENDOLOGIX). DUE TO THE ANGULATED NECK, THE AFX2 BSG DELIVERED VIA THE LEFT FEMORAL ARTERY AND IMPLANTED TO THE DISTAL PART OF THE NECK. THE AFX VELA INFRARENAL AND GORE CUFF WERE THEN IMPLANTED IN THE PROXIMAL PART OF THE VELA INFRARENAL. IT WAS CONFIRMED THAT THERE WERE NO ENDOLEAKS. THE PROCEDURE WAS COMPLETED. APPROXIMATELY FOUR YEARS POST INITIAL PROCEDURE IT WAS OBSERVED THAT THE AFX2 BSG AND THE AFX VELA INFRARENAL WERE DISCONNECTED, AND THE ANEURYSM HAD INCREASED FROM 54MM TO 60MM. AN ABDOMEN DOPPLER ULTRASOUND CONFIRMED A TYPE IIIA ENDOLEAK FROM THE DISCONNECTION BETWEEN THE AFX2 BSG AND AFX VELA INFRARENAL. REINTERVENTION WAS COMPLETED BY ESTABLISHING A PULL-THROUGH USING THE RIGHT FEMORAL ARTERY AND LEFT BRACHIAL ARTERY AND BY BALLOONING INSIDE, THE AFX2 BSG AND THE AFX VELA INFRARENAL WERE MIGRATED BACK INTO POSITION. NON-ENDOLOGIX ENDURANT 28MM AORTIC EXTENSION, AND TWO ENDURANT 28MM ILIAC EXTENDERS WERE ALSO IMPLANTED FOR REINFORCEMENT. THE PROCEDURE WAS COMPLETED. IT WAS C

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 22186729 ↗
• InjuryJun 19, 2024Collapse; Off-Label Use; Obstruction of Flow; Collapse; Off-Label Use; Obstruction of Flow

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2023 WITH THE IMPLANTATION OF AN AFX2 BIFURCATED STENT GRAFT AND A GORE (NON-ENDOLOGIX) CUFF. THIS CASE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE COMBINATION OF AFX WITH GORE DEVICES. APPROXIMATELY FOUR (4) MONTHS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A RIGHT LIMB OCCLUSION. REINTERVENTION WAS COMPLETED WITH THE IMPLANTATION OF A BARE-METAL STENT IN BOTH LIMBS. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19568140 ↗
• InjuryDec 22, 2023Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT AN ENDURANT (NON-ENDOLOGIX) AORTIC EXTENSION WAS IMPLANTED FIRST JUST BELOW THE RENAL ARTERY FOLLOWED BY THE AFX2 BIFURCATED STENT GRAFT. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. AN ANGIOGRAM SHOWED A TYPE 3 ENDOLEAK; HOWEVER, IT COULD NOT BE DETERMINED IF THE ENDOLEAK WAS A TYPE 3A OR TYPE 3B. TOUCH-UP WAS PERFORMED AT THE STENT GRAFTS JUNCTION, BUT THE ENDOLEAK DID NOT RESOLVE. AN AFX SUPRARENAL AORTIC EXTENSION WAS ADDED BELOW THE RENAL ARTERIES. THE ENDOLEAK RESOLVED AND THE PROCEDURE WAS COMPLETED. APPROXIMATELY FIVE AND HALF (5.5) YEARS POST INITIAL PROCEDURE, DURING FOLLOW UP ANEURYSM ENLARGEMENT WAS OBSERVED AND A TYPE 2 ENDOLEAK WAS SUSPECTED. AN ANGIOGRAM WAS PERFORMED ON 13 NOVEMBER 2023 AND SHOWED AN ENDOLEAK ABOVE THE BIFURCATION WHICH DETERMINED THIS TO BE A TYPE 3B ENDOLEAK. NO INTERVENTION WAS PERFORMED AT THIS TIME. ON 5 DECEMBER 2023 A SECONDARY PROCEDURE WAS PERFORMED WHERE AN AFX2 BIFURCATED STENT GRAFT WAS USED TO RELI

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 18387145 ↗
• InjuryMar 8, 2023Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL PROXIMAL EXTENSION. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS HOSPITALIZED DUE TO A RUPTURED ANEURYSM AND A TYPE IIIA ENDOLEAK WITH COMPLETE COMPONENT SEPARATION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) MEDTRONIC (NON-ENDOLOGIX) ENDURANT LEG AND ONE (1) GORE (NON-ENDOLOGIX)CTAG STENT GRAFT ON (B)(6) 2023. THE ENDOLEAK WAS REPORTEDLY RESOLVED.

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 16504725 ↗
• InjuryMay 23, 2022Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available; Material Puncture/Hole; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO EMERGENT USE OF THE AFX SYSTEM PER DEVICE IFU. APPROXIMATELY (3) THREE YEAR POST INITIAL PROCEDURE A COMPUTERIZED TOMOGRAPHY (CT) SCAN VISUALIZED A TYPE 3A ENDOLEAK. RE-INTERVENTION WAS COMPLETED WITH THE IMPLANT OF AN AFX VELA SUPRARENAL WHICH RESOLVED THE TYPE 3A ENDOLEAK. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 14471400 ↗
• InjuryJan 26, 2022Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY TREATED FOR AORTIC STENOSIS (OFF-LABEL USE DUE TO NO ABDOMINAL AORTIC ANEURYSM) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. RESULTS WERE GOOD AT THE END OF THE PROCEDURE. FORTY-THREE (43) DAYS POST PROCEDURE RE-OCCLUSION WAS IDENTIFIED AT ROUTINE FOLLOW-UP. REINTERVENTION WAS COMPLETED WITH THROMBOLYTIC THERAPY ONLY. REPORTEDLY, THE PATIENT WAS IN THE HOSPITAL RECOVERING AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13359959 ↗
• InjuryDec 16, 2021Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA), WITH A DIAMETER OF 50MM, WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX SUPRARENAL AORTIC EXTENSION. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE REINTERVENTION WAS PERFORMED TO TREAT THE ANEURYSM ENLARGEMENT AS IT HAD INCREASED TO 80MM WITH SUSPECTED TYPE IA ENDOLEAK. A GORE (NON-ENDOLOGIX) 26X3.3 WAS IMPLANTED TO TREAT THE TYPE IA ENDOLEAK; HOWEVER, A SEAL WAS NOT ACHIEVED. IT WAS THEN SUSPECTED THAT THERE WAS A TYPE IIIA OR TYPE IIIB ENDOLEAK. AN ENDURANT (NON-ENDOLOGIX) 28X82 WAS DEPLOYED WITH SUCCESSFUL SEAL. PATIENT STATUS POST-REINTERVENTION WAS NOT PROVIDED (REPORTED UNDER MFR# 2031527-2021-00498). APPROXIMATELY TWO AND A HALF (2.5) YEARS POST-REINTERVENTION COMPUTERIZED TOMOGRAPHY IDENTIFIED THAT THE ANEURYSM ENLARGEMENT INCREASED TO 130MM AND THERE WAS A TYPE IIIA ENDOLEAK WITH JUNCTION SEPARATION BETWEEN AFX2 BIFURCATED STENT GRAFT AND AFX SUPRARENAL AORTIC EXTENSION). THE PHYSICIAN ELECTED TO PLACE AN ENDURANT (NON-ENDOLOGIX) 28X70 TO OVERLAP WITH THE DISTAL AREA OF THE AFX SUPRARENAL AORTIC EXTENSION BY 30MM; HOWEVER, THE ENDURANT (NON-ENDOLOGIX) STENT GRAFT DID NOT

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13018372 ↗
• InjuryDec 15, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA), WITH A DIAMETER OF 50MM, WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX SUPRARENAL AORTIC EXTENSION. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE REINTERVENTION WAS PERFORMED TO TREAT THE ANEURYSM ENLARGEMENT AS IT HAD INCREASED TO 80MM WITH SUSPECTED TYPE IA ENDOLEAK. A GORE (NON-ENDOLOGIX) 26X3.3 WAS IMPLANTED TO TREAT THE TYPE IA ENDOLEAK; HOWEVER, A SEAL WAS NOT ACHIEVED. IT WAS THEN SUSPECTED THAT THERE WAS A TYPE IIIA OR TYPE IIIB ENDOLEAK. AN ENDURANT (NON-ENDOLOGIX) 28X82 WAS DEPLOYED WITH SUCCESSFUL SEAL. PATIENT STATUS POST-REINTERVENTION WAS NOT PROVIDED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 13011807 ↗
• InjuryOct 20, 2021Difficult or Delayed Positioning; Entrapment of Device; Difficult to Remove; Malposition of Device; Device Damaged by Another Device; Difficult or Delayed Positioning; Entrapment of Device; Difficult to Remove; Malposition of Device; Device Damaged by Another Device

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. APPROXIMATELY THREE (3) POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY DUE TO PELVIC FRACTURE. A SUSPECTED TYPE 3B ENDOLEAK WAS IDENTIFIED (REPORTED UNDER MFR# 2031527-2021-00444). IT IS UNKNOWN WHETHER THE ENDOLEAK OCCURRED DUE TO THE PHYSICAL IMPACT ASSOCIATED WITH THE FRACTURE. REINTERVENTION WAS PERFORMED WITH AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT. DURING THE DEPLOYMENT PROCESS, THE CONTRALATERAL LIMB OF THE NEW AFX2 WAS UNABLE TO BE DEPLOYED DUE TO THE CONTRALATERAL WIRE BECOMING CAUGHT IN THE PREVIOUSLY DEPLOYED AFX2. THE IPSILATERAL LIMB (RIGHT SIDE) WAS THEREFORE DEPLOYED, AND THE DELIVERY SYSTEM WAS REMOVED; HOWEVER, THE CONTRALATERAL LIMB STILL COULD NOT BE DEPLOYED WITH ITS WIRE AND COVER REMAINING IN THE BODY. ANGIOGRAPHY CONFIRMED THAT THE SUSPECTED TYPE 3B ENDOLEAK HAD BEEN RESOLVED AND THERE WAS BLOOD FLOW IN THE CONTRALATERAL SIDE. AFTER PART OF THE CONTRALATERAL WIRE AND THE CONTRALATERAL LIMB COVER WAS CUT OFF FROM THE IPSILATERAL SIDE AND THE CONTRALATERAL SIDE RESPECTIVELY, THE PROCEDURE WAS COMPLETED WITH THE UNREMOVABLE PART OF

  Patient problems: Device Embedded In Tissue or Plaque; Stenosis

  MAUDE report 12669545 ↗
• InjuryOct 20, 2021Unintended Movement; Unintended Movement

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX VELA SUPRARENALS. APPROXIMATELY TWO (2) YEARS AND SIX (6) MONTHS POST INITIAL PROCEDURE THE ROUTINE FOLLOW-UP IDENTIFIED IMPLANT MOVEMENT, AN ENDOLEAK AT AN INDETERMINATE ORIGIN AND COMPONENT-OVERLAP DECREASE TO 2CM. AT REINTERVENTION IT WAS DETERMINED THAT IT WAS A TYPE II ENDOLEAK (NON-DEVICE RELATED). THE PHYSICIAN ELECTED TO DEPLOY AN AFX VELA INFRARENAL AND AN AFX VELA SUPRARENAL TO INCREASE THE OVERLAP AND MITIGATE FUTURE DISCONNECTION. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Failure of Implant

  MAUDE report 12668765 ↗
• InjuryMay 10, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 BIFURCATED STENT GRAFT AND AFX VELA SUPRARENAL. DURING THE INITIAL IMPLANT PROCEDURE, A LEAK WAS IDENTIFIED AT THE BIFURCATION (PROBABLE TYPE IIIB ENOLEAK). THE PHYSICIAN ELECTED TO IMPLANT TWO (2) GORE (NON-ENDOLOGIX) CUFFS AT THE BIFURCATION, BUT THE ENDOLEAK PERSISTED. THE PHYSICIAN THEN ELECTED TO IMPLANT AN ADDITIONAL AFX2 BIFURCATED STENT GRAFT, WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK. THE PROCEDURE WAS CONCLUDED, AND NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11802426 ↗
• InjuryDec 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA INFRARENAL STENT GRAFT EXTENSION. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO CONCOMITANT USE WITH PRODUCTS OUTSIDE THE IFU (PREVIOUSLY PLACED BARE METAL STENTS IN THE EXTERNAL ILIAC ARTERIES ON UNKNOWN DATE). APPROXIMATELY SEVEN (7) MONTHS POST INITIAL PROCEDURE A COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED A POSSIBLE TYPE IIIA ENDOLEAK. THE PHYSICIAN COMPLETED A SUCCESSFUL REINTERVENTION AND IMPLANTED A VELA STENT GRAFT EXTENSION AND TWO (2) NON-ENDOLOGIX EXCLUDER DEVICES. THE ENDOLEAK WAS RESOLVED AND THE PATIENT IS DOING WELL. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT DETERMINED THAT THE TYPE IIIA ENDOLEAK EVENT/INCIDENT WAS REFUTED. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION. THE FINAL PATIENT STATUS WAS REPORTED BEING STABLE POST THE RE-INTERVENTION. A COMPLAINT IS NOT WARRANTED SINCE THERE IS NO ALLEGED DEFICIENCY RELATED TO IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 11084643 ↗
• InjurySep 21, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT CALCIFICATION WAS PRESENT IN THE PROXIMAL AORTIC NECK AND AROUND THE BIFURCATION OF THE AORTA. AN INTRAOPERATIVE TYPE 1A AND TYPE 3A ENDOLEAK WERE IDENTIFIED. AN ADDITIONAL VELA INFRARENAL PROXIMAL EXTENSION WAS IMPLANTED AND BALLOON TOUCH-UP WAS PERFORMED BUT THE ENDOLEAKS WERE STILL NOT RESOLVED. THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE. THE PATIENT WILL BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 10561242 ↗
• DeathFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, 5 MONTHS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH A ANEURYSM RUPTURE AND DUODENUM DAMAGE. THE PHYSICIAN PERFORMED AN EMERGENCY ENDOVASCULAR ANEURYSM REPAIR AND ELECTED TO PLACE AN EXCLUDER CUFF (NON-ENDOLOGIX). THE EXCLUDER CUFF WAS SUCCESSFULLY IMPLANTED, BUT THE PATIENT PASSED AWAY FROM EXCESSIVE BLEEDING. DUODENUM DAMAGE WAS CAUSED BY THE IMPACT AND PRESSURE FROM ANEURYSM RUPTURE AND NOT DUE TO DEVICE CONTACT. CORRECTION: THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS NOTED THAT THE VESSEL CONDITION WAS NOT GOOD AT INITIAL IMPLANT WITH THROMBI IN THE PROXIMAL LANDING ZONE. POST COMPUTERIZED TOMOGRAPHY SHOWED THAT THE ANEURYSM SIZE HAD DECREASED. PATIENT STATUS WAS GOOD. APPROXIMATELY, 5 MONTHS POST INITIAL PROCEDURE THE PATIENT PRESENTED WITH STOMACH PAIN AND THROMBI WAS IDENTIFIED OUTSIDE OF THE GRAFT. THE PHYSICIAN PERFORMED AN EMERGENCY ENDOVASCULAR ANEURYSM REPAIR DUE TO ANEURYSM RUPTURE AND DUODENUM DAMAGE. AN EXCLUD

  Patient problems: Death; Failure of Implant; Rupture

  MAUDE report 9759423 ↗
• InjuryOct 25, 2019Complete Blockage; Fracture; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Complete Blockage; Fracture; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT. THE PRE-CASE PLAN WAS REVIEWED INDICATING SEVERAL AREA'S OF ANATOMY OUTSIDE THE INDICATIONS FOR USE. THE FINAL ANGIOGRAM SHOWED THERE WAS THROMBUS PRESENT (LOCATION OF THE THROMBUS WAS NOT REPORTED). LATER THE SAME DAY, THE DEVICE WAS EXPLANTED DUE TO AN OCCLUSION (LOCATION OF THE OCCLUSION WAS NOT REPORTED) AND A SURGICAL GRAFT (NON-ENDOLOGIX) WAS IMPLANTED. IT WAS ALSO REPORTED AT A LATER DATE THAT THE SURGICAL GRAFT MIGHT BE INFECTED. THE PATIENT IS CURRENTLY DOING BETTER 2 WEEKS POST EXPLANT. ADDITIONAL INFORMATION RECEIVED PER PRODUCT EVALUATION CONFIRMING THAT THE STENT CAGE OF THE BIFURCATED STENT GRAFT SHOWED EVIDENCE OF A STRUT FRACTURE AT THE PROXIMAL PORTION OF THE DEVICE. NOTE: THE INITIAL REPORT TO PATIENT IDENTIFIER (B)(6) WAS INADVERTENTLY NEVER SUBMITTED UNDER THE ASSIGNED MFR. REPORT # 2031527-2019-00471; RATHER, THE INITIAL REPORT PER MFR. REPORT # 2031527-2019-00466 (INTENDED FOR PATIENT IDENTIFIER (B)(6) ) WAS SUBMITTED IN ITS PLACE ON 23 OCTOBER 2019 FOR A SEPARATE EVENT/PATIENT. DUE TO THE CONFUSION, A DUPLICATE INITIAL REPORT FOR PATIENT IDENTIFIER (B)(6) WAS ALSO SUBMITTED UNDER MFR. REPORT # 2031

  Patient problems: Occlusion; Thrombus; Unspecified Infection

  MAUDE report 9241336 ↗
• InjuryOct 23, 2019Complete Blockage; Fracture; Misconnection; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Complete Blockage; Fracture; Misconnection; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT. THE PRE-CASE PLAN WAS REVIEWED INDICATING SEVERAL AREA'S OF ANATOMY OUTSIDE THE INDICATIONS FOR USE. THE FINAL ANGIOGRAM SHOWED THERE WAS THROMBUS PRESENT (LOCATION OF THE THROMBUS WAS NOT REPORTED). LATER THE SAME DAY, THE DEVICE WAS EXPLANTED DUE TO AN OCCLUSION (LOCATION OF THE OCCLUSION WAS NOT REPORTED) AND A SURGICAL GRAFT (NON- ENDOLOGIX) WAS IMPLANTED. IT WAS ALSO REPORTED AT A LATER DATE THAT THE SURGICAL GRAFT MIGHT BE INFECTED. THE PATIENT IS CURRENTLY DOING BETTER 2 WEEKS POST EXPLANT.

  Patient problems: Failure of Implant; Occlusion; Thrombus; Unspecified Infection

  MAUDE report 9224444 ↗
• InjuryOct 8, 2019Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device

  ADDITIONAL INFORMATION: DURING THE INVESTIGATION OF THIS EVENT, STENOSIS IN THE AREA OF THE AORTIC DISSECTION WAS ALSO IDENTIFIED.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 9168741 ↗
• InjurySep 23, 2019Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) MONTHS POST INITIAL PROCEDURE, A GRAFT OCCLUSION WAS IDENTIFIED. IT WAS REPORTED BY THE PHYSICIAN THAT THE OCCLUSION WAS MOST LIKELY DUE TO THE PATIENT'S DRUG USE. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO PERFORMED AN AX-BI-FEM BYPASS WITH NON ENDOLOGIX DEVICES. THE PATIENT WAS REPORTED AS DOING WELL POST INTERVENTION.

  Patient problems: Occlusion

  MAUDE report 9107666 ↗
• InjuryMay 8, 2019Material Puncture/Hole; Product Quality Problem; Material Integrity Problem; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. DURING THE INITIAL PROCEDURE AND AFTER THE DEVICES WERE DEPLOYED, ANGIOGRAPHY SHOWED A TYPE IIIB ENDOLEAK AT THE AORTIC BIFURCATION. A SECOND BIFURCATED DEVICE WAS THEN IMPLANTED INSIDE THE FIRST, AND THE ENDOLEAK WAS CONFIRMED RESOLVED. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8591725 ↗
• DeathMar 18, 2019Off-Label Use; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Off-Label Use; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). AN INTRAOPERATIVE TYPE 1A ENDOLEAK WAS IDENTIFIED AT TIME OF IMPLANT HOWEVER THE PHYSICIAN ELECTED NOT TO TREAT AT THAT TIME. A SECONDARY PROCEDURE WAS COMPLETED 20 DAYS POST INITIAL PROCEDURE. THE PHYSICIAN ELECTED TO IMPLANTED AN OVATION IX STENT GRAFT EXTENDER TO RESOLVE THIS TYPE 1A ENDOLEAK. IT WAS REPORTED THAT THE AORTIC TREATMENT WAS AN PALLIATIVE INTERVENTION AS THE PATIENT WAS IN THE FINAL STAGES OF CANCER. THE PATIENT EXPIRED SEVEN (7) DAYS POST INTERVENTION (NON-AAA RELATED).

  Patient problems: Death

  MAUDE report 8430974 ↗
• InjuryJul 3, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PRIMARY PROCEDURE WAS PERFORMED BY DR. (B)(6) AT (B)(6) MEDICAL CENTER, IN (B)(6) IN (B)(6), ON (B)(6) 2017. PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT, A AFX VELA SUPRARENAL, A AFX LIMB STENT GRAFT, AND AN OVATION IX EXTENDER. ON (B)(6) 2018, IT WAS DISCOVERED THAT THE PATIENT HAD A INDETERMINATE ENDOLEAK (POSSIBLE TYPE 3A) BETWEEN THE MAIN BODY LIMB AND LEFT DISTAL EXTENSION. ON (B)(6) 2018, THE LEFT DISTAL EXTENSION WAS RELINED WITH ANOTHER AFX LIMB STENT GRAFT OF THE SAME SIZE. COMPLETION ANGIO SHOWED NO FURTHER EVIDENCE OF A TYPE 3A ENDOLEAK, BUT DID REVEAL A PERSISTENT TYPE 2 ENDOLEAK. PATIENT WAS REPORTED TO BE IN A STABLE CONDITION POST OP. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 7658248 ↗
• InjuryFeb 20, 2018Failure To Adhere Or Bond; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Failure To Adhere Or Bond; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  DURING THE INITIAL IMPLANT OF AN AFX BIFURCATED AND INFRARENAL EXTENSION AN ANGIO WAS PERFORMED AND THE PHYSICIAN NOTED A POSSIBLE ENDOLEAK OR A NORMAL GRAFT EXPANSION. THE PHYSICIAN ELECTED TO INFLATE AN AORTIC BALLOON IN THE NECK AND THE REST OF THE AORTIC PORTION OF AFX DEVICE. THROUGH ANGIO, IT WAS NOTED THAT THE SHAPE OF THE STENT CHANGED AND CONTRAST WAS SEEN FLOWING OUTSIDE THE STENT. THE PHYSICIAN COULD NOT VERIFY WHAT TYPE OF LEAK WAS PRESENT AND ELECTED TO CONCLUDE THE PROCEDURE AND MONITOR THE PATIENT. PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 7282142 ↗
• InjuryJan 11, 2018Positioning Failure; Positioning Failure

  ON (B)(6) 2017, AN EVAR WAS PERFORMED FOR A PATIENT WITH ABDOMINAL AORTIC ANEURYSM. DURING THIS PROCEDURE THE BIFURCATED STENT WAS REPORTED TO NOT DEPLOY. SINCE THE BIFURCATED STENT WOULD NOT DEPLOY, THE PHYSICIAN ELECTED TO REMOVE THE STENT HOWEVER THE STENT BECAME STUCK ON A NON- ENDOLOGIX STENT. DUE TO THE STENT BECOMING STUCK, THE PHYSICIAN ELECTED TO DO AN OPEN SURGERY TO RESOLVE THIS ISSUE. THE PATIENT WAS REPORTED IN STABLE CONDITION AND THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 7183848 ↗
• DeathJun 26, 2017Partial Blockage; Occlusion Within Device; Off-Label Use; Partial Blockage; Occlusion Within Device; Off-Label Use

  AN AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED TO TREAT AN AIOD OCCLUSIVE AORTA. THE DATE OF THE INDEX PROCEDURE, IT WAS NOTED THAT THE STENT GRAFT WAS THROMBOSED. A RE-INTERVENTION TO DE-CLOT THE GRAFT WAS COMPLETED, HOWEVER THE PATIENT WAS NOTED AS NOT WELL AFTER THE RE-INTERVENTION AND REMAINED ON A VENTILATOR. 1 DAY POST-OP, THE STENT GRAFT THROMBOSED AGAIN, AND A SECOND RE-INTERVENTION TO DE-CLOT THE GRAFT WAS COMPLETED. THE PATIENT REMAINED ON A VENTILATOR AFTER THE SECOND RE-INTERVENTION. APPROXIMATELY 1 WEEK POST-OP, A RE-INTERVENTION WAS COMPLETED AND A PORTION OF THE COLON WAS REMOVED AND A COLOSTOMY WAS PERFORMED. THE PATIENT REMAINS ON VENTILATOR AND DIALYSIS. AS OF THE DATE OF THIS REPORT THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Death; Failure of Implant; Ischemia; Occlusion; Renal Failure; Reocclusion; Respiratory Failure

  MAUDE report 6667914 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040002. One submission often covers many models, so check the product and lot details in each record.

• Z-1048-2017 · Jan 4, 2017 · Terminated
  AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C
• Z-1049-2017 · Jan 4, 2017 · Terminated
  AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 B
• Z-1037-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• Z-1039-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1038-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (A
• Z-1047-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoili
• Z-1054-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• Z-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• Z-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• Z-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.