Vela Proximal Endograft System A28-28/C75-O20 VRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00818009013583), received between Jan 26, 2016 and Jan 7, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Leak/Splash” (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.

• InjuryJan 7, 2026Off-Label Use; Lack of Effect

  THE PATIENT WAS IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT SYSTEM, AN AFX VELA SUPRARENAL EXTENSION, AND AFX VELA INFRARENAL EXTENSION FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2025. IT WAS REPORTED ON (B)(6) 2025 THE PATIENT PRESENTED EMERGENTLY, AN ANGIOGRAM REVEALED A TYPE IA ENDOLEAK. THE PHYSICIAN IMPLANTED AN AFX VELA SUPRARENAL AORTIC CUFF EXTENSION EXTENDING PROXIMALLY CLOSER TO THE RENAL ARTERIES, AND A SEAL WAS ACHIEVED. THE TYPE IA ENDOLEAK WAS RESOLVED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 23991929 ↗
• InjuryJul 5, 2024Lack of Effect; Lack of Effect

  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 AORTIC EXTENSION ON (B)(6) 2018. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, A FOLLOW UP COMPUTED TOMOGRAPHY (CT) AND ANGIOGRAM REVEALED THERE WAS A TYPE IA ENDOLEAK COMING OFF THE LEFT SIDE POSTERIOR OF THE STENT GRAFT. INJECTIONS WITH A PIGTAIL CATHETER WITHIN THE STENT GRAFT WAS PERFORMED, AND THERE WERE NO ENDOLEAKS DETECTED THROUGH THE GRAFT MATERIAL. BECAUSE OF THE PATIENTS CLINICAL PRESENTATION A PALMAZ (NON-ENDOLOGIX) STENT WAS IMPLANTED. AFTER POST DILATION, SUBSEQUENT IMAGING SHOWED THE TYPE IA ENDOLEAK WAS GREATLY REDUCED. THE PHYSICIAN WAS SATISFIED THAT THE PATIENT COULD GO FORWARD WITH A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR).

  Patient problems: Clinical Endoleak

  MAUDE report 19681030 ↗
• InjuryApr 26, 2024Migration; Migration

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2015 WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, TWO AFX VELA INFRARENAL, AND AN AFX VELA SUPRARENAL. IT WAS REPORTED ON (B)(6) 2024 THAT ROUTINE FOLLOW UP IDENTIFIED MIGRATION OF THE AFX VELA SUPRARENAL WITH A TYPE IA ENDOLEAK. REINTERVENTION WAS PERFORMED WITH THE IMPLANT OF AN ALTO ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2024, RESOLVING THE TYPE IA ENDOLEAK. THE PATIENT WAS TO BE DISCHARGED ONE DAY POST-REINTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 19192584 ↗
• InjuryOct 2, 2023Material Invagination; Migration; Material Invagination; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN AND A HALF (7.5) YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, IT WAS NOTED THAT THE SUPRARENAL AORTIC EXTENSION HAS MIGRATED, FOLDED OVER IN THE SACK, AND THERE IS A TYPE1A ENDOLEAK. THE AAA IS NOW 7.9 CM (CENTERLINE MEASUREMENT). THE PATIENT IS ASYMPTOMATIC AND IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17853696 ↗
• InjuryJul 18, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND TWO (2) AFX VELA SUPRARENAL PROXIMAL EXTENSIONS. APPROXIMATELY FORTY-TWO (42) DAYS POST-INITIAL PROCEDURE, THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP EXAMINATION, DURING WHICH A POTENTIAL ENDOLEAK OF TYPE IA OR TYPE 2 WAS SUSPECTED. IN ORDER TO ASCERTAIN THE PRECISE NATURE OF THE OBSERVED ISSUE, THE PATIENT IS SCHEDULED TO UNDERGO AN ANGIOGRAM, A DIAGNOSTIC PROCEDURE AIMED AT ACCURATELY IDENTIFYING THE PRESENCE AND CHARACTERISTICS OF THE SUSPECTED ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 17347566 ↗
• InjuryMay 26, 2023Material Puncture/Hole; Lack of Effect; Material Puncture/Hole; Lack of Effect

  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 PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE 1A ENDOLEAK. CURRENTLY, PLANS FOR RE-INTERVENTION ARE UNDER CONSIDERATION. THE PATIENT WAS REPORTEDLY IN GOOD CONDITION. ADDITIONAL INFORMATION: A CLINICAL ASSESSMENT WAS CONDUCTED AND HAS REVEALED INDICATIONS OF ANEURYSM EXPANSION MEASURING 6.1MM, THE PRESENCE OF A TYPE II ENDOLEAK ORIGINATING FROM THE LUMBAR ARTERY, AS WELL AS THE IDENTIFICATION OF A TYPE IIIB ENDOLEAK STEMMING FROM THE DISTAL MAIN BODY. THESE FINDINGS WERE IDENTIFIED DURING THE REVIEW OF THE COMPUTERIZED TOMOGRAPHY (CT) SCANS CONDUCTED AT THE 3-MONTH AND 3-YEAR POST-IMPLANT ON JULY 12, 2023, AND WERE NOT INCLUDED IN THE INITIAL EVENT REPORT.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17015061 ↗
• InjuryDec 5, 2022Device Dislodged or Dislocated; Lack of Effect; Device Dislodged or Dislocated; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AND A VELA SUPRARENAL PROXIMAL EXTENSION. DURING THE PROCEDURE, IT WAS REPORTED THAT THE VELA SUPRARENAL SLIPPED DOWN AND CAUSED AN ENDOLEAK TYPE I. A SECONDARY VELA SUPRARENAL WAS IMPLANTED. THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Clinical Endoleak; Failure of Implant

  MAUDE report 15921127 ↗
• InjuryMar 24, 2022Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  THE PATIENT WAS BEING TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND TWO (2) AFX LIMB STENT GRAFT. THE AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL WERE DEPLOYED. DURING THE ADVANCEMENT OF AN AFX LIMB STENT GRAFT, THE AFX VELA SUPRARENAL WAS PUSHED PROXIMAL OVER THE RENALS WHILE TRYING TO RE-ADVANCE THE SHEATH TO PLACE THE AFX LIMB STENT GRAFT. AN ATTEMPT TO PULL THE AFX LIMB STENT GRAFT DOWN WAS MADE; HOWEVER, IT WAS UNSUCCESSFUL. THE PHYSICIAN ELECTED TO SURGICALLY OPEN THE AORTA, EXPLANTED THE AFX VELA SUPRARENAL, PLACED AN OPEN GRAFT (NON-ENDOLOGIX) UNDER THE RENALS, AND SEWED THE DISTAL PART OF THE OPEN GRAFT TO THE TOP OF THE AFX2 BIFURCATED STENT GRAFT. POST-PROCEDURE THE IMPLANTED DEVICES BECAME OCCLUDED. THE PATIENT UNDERWENT AORTOBIFEMORAL BYPASS. THE PATIENT WAS ON A VENTILATOR; HOWEVER, STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13891708 ↗
• InjuryMay 7, 2021Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE (5) YEARS POST INITIAL IMPLANT AND DURING ROUTINE FOLLOW-UP, THE CT (COMPUTED TOMOGRAPHY) SCAN IDENTIFIED CAUDAL MIGRATION OF THE PROXIMAL AFX GRAFT MEASURING GREATER THAN 10MM. THE PATIENT STATUS WAS NOT REPORTED. NOTE: THIS PATIENT IS PART OF A CLINICAL STUDY, REFERENCE MFR. REPORT # 3008011247-2021-00026 FOR INITIAL REPORT TO PATIENT ID (B)(6), WHICH WAS SUBMITTED WITH THE INCORRECT CFN/FEI #.

  Patient problems: Failure of Implant

  MAUDE report 11793641 ↗
• InjuryApr 13, 2021Migration; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL IMPLANT, DURING ROUTINE FOLLOW UP THE COMPUTED TOMOGRAPHY SCAN IDENTIFIED CAUDAL MIGRATION OF THE PROXIMAL AFX GRAFT > 10MM. NO FURTHER INFORMATION PROVIDED. PATIENT STATUS WAS NOT REPORTED. NOTE: THIS PATIENT IS PART OF A CLINICAL STUDY. ADDITIONAL INFORMATION: AFTER FURTHER REVIEW, THE INITIAL REPORT TO PATIENT ID (B)(6) WAS SUBMITTED WITH THE WRONG CFN/FEI # (B)(4), WHICH IS NOT ASSOCIATED WITH THE AFX PRODUCT LINE. THEREFORE, A CORRECTIVE INITIAL/FINAL REPORT WILL BE SUBMITTED FOR PATIENT ID (B)(6) WITH THE APPROPRIATE CFN/FEI # (B)(4). PLEASE SEE MFR. REPORT # 2031527-2021-00195. THIS EVENT PER MFR. REPORT # 3008011247-2021-00026 IS THUS NO LONGER REPORTABLE.

  Patient problems: Failure of Implant

  MAUDE report 11661290 ↗
• InjuryDec 16, 2020Use of Device Problem; Unintended Movement; Use of Device Problem; Unintended Movement

  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). APPROXIMATELY SIXTEEN (16) DAYS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN, NAUSEA AND VOMITING. A COMPUTED TOMOGRAPHY (CT) REVEALED THE PROXIMAL EXTENSION HAD SLIPPED DOWN (MIGRATED) CAUSING ANEURYSM GROWTH AND A RUPTURE. THE PHYSICIAN TREATED THIS EVENT BY IMPLANTING ANOTHER VELA SUPRARENAL STENT GRAFT EXTENSION . THE PATIENT WAS REPORTED AS BEING STABLE POST INTERVENTION.

  Patient problems: Aneurysm; Failure of Implant; Pain; Rupture

  MAUDE report 11024343 ↗
• InjurySep 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS PRESENT IN THE EMERGENCY ROOM (ER) WITH ABDOMINAL AND BACK PAIN. A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED AND SHOWED RETROPERITONEAL HEMORRHAGE. THE PATIENT WAS SENT TO ANOTHER HOSPITAL FOR AN INTERVENTION. UPON REVIEW OF THE COMPUTED TOMOGRAPHY (CT) BY THE PHYSICIAN AND RADIOLOGIST, A TYPE 1A ENDOLEAK WAS SUSPECTED AS THE PROXIMAL EXTENSION HAD MOVED 2 CM¿S FROM INITIAL IMPLANTATION. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH GORE (NON - ENDOLOGIX) STENTS TO RESOLVED THIS EVENT AND THE PATIENT WAS REPORTED AS DOING WELL POST INTERVENTION. ADDITIONAL INFORMATION: DURING THE INVESTIGATION OF THE REPORTED EVENT, CLINICAL ASSESSMENT CONFIRMED A RUPTURE BASED ON MEDICAL RECORDS AND IMAGING REVIEWED.

  Patient problems: Pain; Rupture

  MAUDE report 9136965 ↗
• InjuryAug 29, 2019Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT ON (B)(6) 2016. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, A TYPE IIIA ENDOLEAK WITH ANEURYSM ENLARGEMENT WAS DETECTED, AND THE PATIENT WAS RELINED WITH AN ADDITIONAL SUPRARENAL AFX DEVICE AT THE JUNCTION ON (B)(6) 2017 (REFERENCE MFR. REPORT # 2031527-2018-00262). ANOTHER TWO (2) YEARS LATER, THE PATIENT PRESENTED EMERGENTLY WITH A PULSATILE ANEURYSM, AND CT (COMPUTED TOPOGRAPHY) REVEALED AN ENLARGED ANEURYSM SAC (UNKNOWN DIAMETER) WITH ENDOTENSION; HOWEVER, THE EXACT DATE OF EVENT IS UNKNOWN. THE PHYSICIAN ELECTED TO CONVERT THE PATIENT TO OPEN REPAIR ON AN UNKNOWN DATE AND DISCOVERED TWO (2) LARGE HOLES (TYPE IIIB ENDOLEAK) IN THE MOST PROXIMAL SUPRARENAL DEVICE (IMPLANTED AT INITIAL CASE IN 2016). AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm

  MAUDE report 8946121 ↗
• InjuryJun 26, 2019Misconnection; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem; Misconnection; Material Puncture/Hole; Product Quality Problem; Material Integrity Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE, A TYPE IIIA ENDOLEAK WITH COMPONENT SEPARATION AND NON-INTACT FABRIC (TYPE IIIB ENDOLEAK) OF THE PROXIMAL EXTENSION WERE DETECTED DURING ROUTINE EXAM BY A CARDIOLOGIST. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXPLANTING THE AFX DEVICES ON (B)(6) 2019, BUT IT UNKNOWN IF THESE DEVICES ARE AVAILABLE FOR RETURN. THE PATIENT HAS BEEN DISCHARGED HOME WITH FATIGUE, BUT CONDITION IS IMPROVING. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8735811 ↗
• InjuryJun 14, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4.5 YEARS POST INITIAL PROCEDURE, (EXACT DATE WAS NOT PROVIDED) A TYPE 1A ENDOLEAK WAS DETECTED BY COMPUTERIZED TOMOGRAPHY (CTA) DURING ROUTINE FOLLOW-UP. THE FAMILY HAS NOT SCHEDULED AN INTERVENTION AT THIS TIME. THE PATIENT IS REPORTEDLY DOING WELL AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 8701020 ↗
• InjuryMar 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. ONE (1) DAY POST INITIAL PROCEDURE, THE PHYSICIAN NOTED THAT THE PATIENT HAD NO FLOW TO THE RENAL ARTERY, NO URINE OUTPUT, AND HIGH CREATININE LEVELS. AN ULTRASOUND SHOWED THAT THE RENAL ARTERY WAS COVERED; THE PHYSICIAN BELIEVES THAT THIS WAS A RESULT OF THE X-RAY TECHNICIAN INADVERTENTLY MOVING THE X-RAY TUBE DURING THE INITIAL PROCEDURE, WHICH MAY HAVE CHANGED THE LANDING MARK OF THE STENT GRAFT. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY PERFORMING A BYPASS PROCEDURE ON (B)(6) 2019. THE PATIENT WAS STABLE WHEN LEAVING THE OPERATING ROOM. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Occlusion

  MAUDE report 8400966 ↗
• InjuryJul 30, 2018Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF BOTH BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION WERE OCCLUDED. THE PATIENT WAS PRESENTED TO THE HOSPITAL ON (B)(6) 2018 WITH PAIN IN BOTH LEGS AND ABDOMEN. A COMPUTED TOMOGRAPHY (CT) SCAN DEMONSTRATED OCCLUDED BIFURCATED GRAFT AND CUFF. A REINTERVENTION WAS PERFORMED WHERE BOTH GROINS EXPOSED, AND THROMBECTOMY CATHETERS WERE PASSED THROUGH BOTH ILIACS, SFA'S, AND THE ABDOMINAL AORTA. THE CLOT (OCCLUSION) WAS REMOVED. THE MAIN BODY AND CUFF WERE BALLOONED, FOLLOWED BY THE PLACEMENT OF NON- ENDOLOGIX STENTS IN THE COMMON ILIACS TO SUCCESSFULLY RESTORING FLOW THROUGH THE STENT GRAFT AND BILATERAL ILIAC ARTERIES. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED. THIS COMPLAINT IS FOR THE SUPRARENAL STENT GRAFT EXTENSION ONLY ANOTHER REPORT WILL BE CREATED/ SUBMITTED FOR THE BIFURCATED STENT GRAFT .

  Patient problems: Failure of Implant

  MAUDE report 7732073 ↗
• InjuryFeb 15, 2018Partial Blockage; Occlusion Within Device; Partial Blockage; Occlusion Within Device

  PATIENT PRESENTED SYMPTOMATICALLY AND IT WAS DISCOVERED THAT THE PATIENT HAD A LEFT ILIAC LIMB OCCLUSION AND ABUNDANT THROMBUS INSIDE THE GRAFT. PATIENT REPORTED TO BE IN GOOD CONDITION. DURING CLINICAL EVALUATION THAT WAS COMPLETED ON (B)(6) 2018, IT WAS CONFIRMED THROUGH MEDICAL RECORDS THAT THE PATIENT HAD A RE-INTERVENTION ON (B)(6) 2017 WHERE A NON-ENDOLOGIX STENT WAS PLACED. PATIENT WAS DISCHARGED HOME ON (B)(6) 2017. NO ADDITIONAL PATIENT SEQUALAE HAS BEEN REPORTED.

  Patient problems: Claudication; Failure of Implant; Occlusion; Stenosis; Thrombus

  MAUDE report 7275500 ↗
• InjuryJan 5, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED AND VELA SUPRARENAL DEVICE. IT WAS REPORTED THAT THE NECK MEASUREMENT MIGHT BE OFF LABEL. APPROXIMATELY 3 YEARS POST IMPLANT, THE PATIENT PRESENTED WITH EITHER AN ENDOLEAK TYPE 1A OR 3A. ON (B)(6) 2017 THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX PROXIMAL CUFF AND THE LEAK PERSISTED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND UNDER THE CARE OF ANOTHER PHYSICIAN. THE NEW PHYSICIAN ELECTED TO PLACE ANOTHER NON-ENDOLOGIX AND PERFORMED A CHIMNEY/SNORKEL ON THE RIGHT RENAL TO SUCCESSFULLY RESOLVE THE LEAK. NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 7168374 ↗
• InjuryOct 10, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. A 30 DAY FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED THE PATIENT HAD A TYPE 1A ENDOLEAK AND TYPE 2 ENDOLEAK. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS FOR THIS PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 6935989 ↗
• InjuryDec 22, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT INITIALLY IMPLANTED WITH AN INFRARENAL AORTIC EXTENSION AND TWO SUPRARENAL AORTIC EXTENSIONS ON (B)(6) 2016. THE INITIAL IMPLANT DID NOT INCLUDE A MAIN BODY DEVICE DUE TO PATIENT HAVING A LARGE ANEURYSM AND A HYPOGASTRIC ARTERY ON THE LEFT LOCATED 6-8MM FROM THE NATIVE BIFURCATION. ON (B)(6) 2016 A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED A TYPE 1A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL SUPRARENAL AORTIC EXTENSION TO SEAL THE LEAK. THE PROCEDURE WAS COMPLETED AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 6197513 ↗
• InjuryAug 5, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2015 WITH A BIFURCATED DEVICE AND SUPRARENAL AORTIC EXTENSION. UPON FOLLOW UP, COMPUTED TOMOGRAPHY (CT) FROM (B)(6) 2016 SHOWED THE SUPRARENAL AORTIC EXTENSION HAD UNINTENTIONAL MOVEMENT, CAUSING A POTENTIAL TYPE 1A ENDOLEAK. ON (B)(6) 2016, THE PHYSICIAN IMPLANTED A SUPRARENAL AORTIC EXTENSION TO SEAL THE ENDOLEAK. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 5851930 ↗
• InjuryJul 29, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND AN INFRARENAL AORTIC EXTENSION ON (B)(6) 2013. ON (B)(6) 2014 THE PATIENT HAD AN ADDITIONAL SUPRARENAL AORTIC EXTENSION PLACED TO CORRECT A TYPE 1A ENDOLEAK. ON (B)(6) 2016 COMPUTED TOMOGRAPHY (CT) SHOWED AN UNKNOWN ENDOLEAK. ON (B)(6) 2016 AN ANGIOGRAM CONFIRMED A TYPE 1A ENDOLEAK. THE SUBSEQUENT ENDOVASCULAR PROCEDURE WAS DELAYED DUE TO THE POOR HEALTH OF THE PATIENT. THE PATIENT HAS BEEN SCHEDULED FOR AN INTERVENTION WHICH HAS NOT TAKEN PLACE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 5834928 ↗
• InjuryApr 29, 2016Fitting Problem; Activation, Positioning or Separation Problem; Fitting Problem; Activation, Positioning or Separation Problem

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND A LIMB EXTENSION ON (B)(6) 2016. DURING THE INITIAL IMPLANT WHEN DEPLOYING THE AORTIC EXTENSION THE IMPLANT WAS NOT THE CORRECT SIZE AND THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE. DURING THE REMOVAL OF THE DEVICE THE PHYSICIAN DAMAGED THE LEFT FEMORAL ARTERY. THE PHYSICIAN REPAIRED THE ARTERY AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Injury

  MAUDE report 5621280 ↗
• InjuryFeb 6, 2016Leak/Splash

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2016 WITH A BIFURCATED DEVICE AND TWO SUPRARENAL AORTIC EXTENSIONS. A FOLLOW UP ANGIOGRAM REVEALED A TYPE 1A ENDOLEAK AND THE PHYSICIAN ELECTED TO EXPLANT THE STENTS ON (B)(6) 2016. THE PATIENT IS DOING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 5414843 ↗

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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• 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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL

…and 1 more.