TALENT® OCCLUDER OCL12USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994573148), received between May 10, 2017 and Jun 26, 2018 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJun 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT STENT GRAFT SYSTEM AND TALENT OCCLUDER PLUGS WERE IMPLANTED IN A PATIENT FOR THE EMERGENCY ENDOVASCULAR TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM AND WAS GREY IN COLOR UPON ARRIVAL. IT WAS REPORTED THAT THE PHYSICIAN CHOSE THE SIZING OF THE DEVICES VIA ANGIOGRAM CHOOSING AN ENDURANT AUI AND A 16X24X93 ENDURANT LIMB. TWO TALENT OCCLUDER PLUGS WERE IMPLANTED ON THE RIGHT SIDE TO OCCLUDE THE ILIAC ARTERY. ONCE THE EVAR PROCEDURE WAS COMPLETED THE PROCEDURE TRANSITIONED TO A FEM-FEM BYPASS. IT WAS REPORTED THAT THE PATIENTS¿ BLOOD PRESSURE WAS LOW DURING THE ENTIRE PROCEDURE AND REMAINED LOW AFTER THE EVAR. THE PHYSICIAN REMARKED THAT THE PATIENTS ABDOMEN FELT LIKE A DRUM AND THE DECISION WAS MADE TO OPEN UP THE ABDOMEN TO EXPLORE FOR INTERNAL BLEEDING, NONE WAS FOUND YET THE PATIENTS¿ BLOOD PRESSURE KEPT DROPPING. RESUSCITATION WAS ATTEMPTED FOR 20 MINUTES BUT THE PATIENT EXPIRED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO MULTIPLE COMORBIDITIES; CHRONIC RENAL FAILURE AND SHOCK. THE DEFINITIVE CAUSE OF THE RUPTURE COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUEL

  Patient problems: Cardiac Arrest; Death

  MAUDE report 7637046 ↗
• InjuryMay 10, 2017Leak/Splash; Difficult to Remove; Malposition of Device; Leak/Splash; Difficult to Remove; Malposition of Device

  AN ENDURANT II AUI STENT GRAFT SYSTEM AND A TALENT OCCLUDER WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED AS VERY TIGHT AND CALCIFIED AORTIC BIFURCATION. THE RIGHT ILIAC ARTERY MEASURED BETWEEN 6 MM AND 7 MM IN DIAMETER. THE LEFT ILIAC ARTERY MEASURED FROM BETWEEN 4 MM AND 5 MM IN DIAMETER TO BETWEEN 5 MM AND 6 MM IN DIAMETER. THE PROXIMAL AORTIC NECK MEASURED 24 MM IN DIAMETER. THERE WAS SEVERE LEFT ILIAC CALCIFICATION. THERE WAS MODERATE TO SEVERE RIGHT ILIAC CALCIFICATION. THERE WAS MILD CALCIFICATION AT THE PROXIMAL AORTIC NECK. THE PATIENT HAD A WIDE AND CONICAL PROXIMAL AORTIC NECK. THE LEFT RENAL ARTERY WAS THE LOWEST RENAL ARTERY AND THE RIGHT RENAL ARTERY WAS ATROPHIC. IT WAS REPORTED THAT ENDURANT AUI WAS ADVANCED UP TO THE LEFT RENAL STENT. THE ENDURANT AUI WAS INITIALLY DEPLOYED AND IMPLANTED AT THE INTENDED LANDING ZONE. HOWEVER, WHEN THE DELIVERY SYSTEM WAS BEING REMOVED, THERE WERE DIFFICULTIES REMOVING THE DELIVERY SYSTEM. THE GRAFT COVER WAS BELOW THE AREA OF CALCIFIED/TIGHT AORTA AND THE SPINDLE AND TAPER TIP COULD NOT BE RETRACTED BACK TO THE GRAFT COVER. THE PHYSIC

  Patient problems: Injury

  MAUDE report 6557392 ↗