TALENT® OCCLUDER OCL20USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994573063), received between Mar 20, 2018 and May 17, 2018 — classified as 1 death, 1 injury.

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.

• InjuryMay 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TALENT OCCLUDER DEVICE WAS IMPLANTED IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN IMPLANTED THE TALENT OCCULDER INTO THE LEFT COMMON ILIAC ARTERY. A RETROGRADE INJECTION WAS DONE TO SEE IF THE LEFT COMMON ILIAC ARTERY HAD BEEN OCCLUDED WHICH THEN SHOWED EXTRAVASATION INTO THE RETROPERITONEAL SPACE. THE PHYSICIAN PLACED A 16MM OCCLUDER PLUG TO STOP THE BLEEDING, HOWEVER, IT DID NOT WORK. A FLANK INCISION WAS MADE TO VISUALIZE THE LEFT COMMON ILIAC ARTERY AND THE 20MM TALENT OCCLUDER PLUG WAS REMOVED FROM THE VESSEL AS IT HAD TORN THROUGH THE ARTERY. THE 16MM OCCLUDER PLUG WAS ALSO REMOVED. THROUGH SOME DIFFICULTY DUE THE DAMAGED VESSEL, PROLENE SUTURES WERE SOWN OVER THE ARTERY TO STOP THE BLEEDING AND HOMEOSTASIS WAS ACHIEVED. AT THE END OF THE PROCEDURE A FINAL ANGIOGRAM WAS PERFORMED AND NO EXTRAVASATION WAS APPARENT IN THE RETROPERITONEAL SPACE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE CALCIFICATION IN THE LEFT COMMON ILIAC. IT WAS NOTED BY THE PHYSICIAN THAT THERE IS A POSSIBILITY THAT A DISSECTION WAS CREATED IN THE ILIAC AS THE OC

  Patient problems: Vascular Dissection

  MAUDE report 7521473 ↗
• DeathMar 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED UNKNOWN DIAMETER ABDOMINAL AORTIC ANEURYSM AND SUBSEQUENT IMPLANTATION OF ANOTHER ANEURX STENT GRAFT AND ENDURANT STENT GRAFT WAS ALSO PERFORMED. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS RECEIVING TREATMENT WITH THE ATTEMPTED IMPLANTATION OF AN AUI DEVICE BUT THEN EXPIRED DURING THIS PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO MIGRATION OF THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death

  MAUDE report 7353710 ↗