i-ED COIL 390-01H3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04540778176478), received between Jun 2, 2023 and Jun 4, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CASE WAS 3.39MM WIDE ANTERIOR COMMUNICATING ARTERY UNRUPTURED ANEURYSM. FIRST COIL WAS SUCCESSFULLY DEPLOYED WHICH WAS A 3X4 COMPLEX EXTRA SOFT COIL. THE SECOND COIL WAS DEPLOYED AND ABOUT TO DETACH IN THE ANEURYSM WHICH WAS A 1.5 X 3 SILK SOFT. THE CATHETER KICKED OUT IF THE ANEURYSM AND THE COIL WAS REMOVED AND SET ASIDE. NO ISSUE AT THAT TIME. THE ANEURYSM WAS THEN REENTERED WITH A 156CM HEADWAY DUO AND ADDITIONAL SUPPORT FROM THE .038 DAC MOVING DISTALLY. WHEN ENTERING THE ANEURYSM THE CATHETER DID MOVE THE ORIGINAL COIL AND THEN WE STARTED TO DEPLOY THE SECOND COIL. THE COIL WAS OUTSIDE THE ANEURYSM AND THE MD THOUGHT IT WAS THE COIL THAT CAUSED THE RUPTURE/BLEED. THE SECOND COIL REMAINED IN THE PATIENT AND THE MD THOUGHT IT WAS ENOUGH COIL TO PROTECT THE NOW RUPTURED ANEURYSM. UNFORTUNATELY, THE PATIENT HAS SOME SUBARACHNOID HEMORRHAGE (SAH) / INTRAVENTRICULAR HEMORRHAGE (IVH) AND WENT FOR EXTERNAL VENTRICULAR DRAIN (EVD). PATIENT WAS GIVEN MEDICATION.

  Patient problems: Ruptured Aneurysm

  MAUDE report 19464079 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TREATMENT OF LEFT MCA BIFURCATION ANEURYSM, PREVIOUS TREATED A YEAR AGO BY STENT ASSISTED COILING USING A "STRYKER NEUROFORM ATLAS STENT". SPACE TO BE COILED WAS 3.5MM X 2.5MM IN SIZE, BEHIND THE PREVIOUSLY PLACED STENT. "STRYKER EXCELSIOR SL10" MICROCATHETER SELECTED FOR COIL DELIVERY. MICROCATHETER TIP WAS PLACED INTO ANEURYSM THROUGH THE STENT STRUTS. 1ST COIL SELECTED WAS THE "IED COIL COMPLEX INFINI SILKYSOFT (393-020306)", DELIVERED INTO THE ANEURYSM WITHOUT COMPLICATIONS AND DEPLOYED. 2ND COIL SELECTED WAS THE "IED COIL COMPLEX SILKYSOFT (390-01H3)", DELIVERED INTO THE ANEURYSM AND POSITIONED READY FOR DEPLOYMENT. DURING A VISUAL CHECK BEFORE DEPLOYMENT, RUPTURE OF THE ANEURYSM AND CORRESPONDING HEMORRHAGE AND COIL LOOPS OUTSIDE OF THE ANEURYSM WALL INTO THE SUBDURAL SPACE CONFIRMED. CAUSE OF RUPTURE COULD NOT BE IDENTIFIED BUT NOT DIRECTLY RELATED TO COIL. AFTER HEMORRHAGE WAS CONFIRMED A FURTHER 8 IED COILS WERE DEPLOYED INTO THE SPACE TO STOP THE BLEEDING. HEMOSTASIS WAS ACHIEVED APPROXIMATELY 27MINUTES AFTER RUPTURE OF ANEURYSM. AFTER PROCEDURE AN HEMATOMA APPROXIMATELY 3CM WIDE IN SIZE WAS CONFIRMED AT THE POINT OF RUPTURE AND PATIENT WAS IN AN UNSTABLE CONDITION. ON 5/

  Patient problems: Aneurysm

  MAUDE report 17104901 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TREATMENT OF LEFT MCA BIFURCATION ANEURYSM, PREVIOUS TREATED A YEAR AGO BY STENT ASSISTED COILING USING A "STRYKER NEUROFORM ATLAS STENT". SPACE TO BE COILED WAS 3.5MM X 2.5MM IN SIZE, BEHIND THE PREVIOUSLY PLACED STENT. "STRYKER EXCELSIOR SL10" MICROCATHETER SELECTED FOR COIL DELIVERY. MICROCATHETER TIP WAS PLACED INTO ANEURYSM THROUGH THE STENT STRUTS. 1ST COIL SELECTED WAS THE "IED COIL COMPLEX INFINI SILKYSOFT (393-020306)", DELIVERED INTO THE ANEURYSM WITHOUT COMPLICATIONS AND DEPLOYED. 2ND COIL SELECTED WAS THE "IED COIL COMPLEX SILKYSOFT (390-01H3)", DELIVERED INTO THE ANEURYSM AND POSITIONED READY FOR DEPLOYMENT. DURING A VISUAL CHECK BEFORE DEPLOYMENT, RUPTURE OF THE ANEURYSM AND CORRESPONDING HEMORRHAGE AND COIL LOOPS OUTSIDE OF THE ANEURYSM WALL INTO THE SUBDURAL SPACE CONFIRMED. CAUSE OF RUPTURE COULD NOT BE IDENTIFIED BUT NOT DIRECTLY RELATED TO COIL. AFTER HEMORRHAGE WAS CONFIRMED A FURTHER 8 IED COILS WERE DEPLOYED INTO THE SPACE TO STOP THE BLEEDING. HEMOSTASIS WAS ACHIEVED APPROXIMATELY 27MINUTES AFTER RUPTURE OF ANEURYSM. AFTER PROCEDURE AN HEMATOMA APPROXIMATELY 3CM WIDE IN SIZE WAS CONFIRMED AT THE POINT OF RUPTURE AND PATIENT WAS IN AN UNSTABLE CONDITION. ON 5/

  Patient problems: Ruptured Aneurysm

  MAUDE report 17045876 ↗