Smart Coil 400SMTSTD0410Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814548014609), received between Mar 13, 2017 and Mar 13, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Protrusion/Extrusion” (2 reports).

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.

• InjuryMar 13, 2017Material Protrusion/Extrusion; Unintended Movement; Material Protrusion/Extrusion; Unintended Movement

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, AFTER THE THIRD SMART COIL WAS DEPLOYED AND DETACHED, THE ANGIOGRAPHY SHOWED A PROTRUSION OF A PREVIOUSLY PLACED COIL. THE PHYSICIAN CONTINUED THE PROCEDURE BY PLACING SIX ADDITIONAL SMART COILS. TOWARDS THE END OF THE PROCEDURE, CLOT FORMATION WAS IDENTIFIED ON THE DISPLACED LOOP OF COIL AND AN INTEGRILIN DRIP WAS STARTED. THE PHYSICIAN THEN DECIDED TO PLACE A STENT IN ORDER TO TACK THE PROTRUDING COIL AGAINST THE WALL OF THE VESSEL. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2017. THE REPORTED CLOT FORMATION WAS ADJUDICATED TO HAVE NO RELATIONSHIP TO THE PENUMBRA DEVICES. HOWEVER, THE REPORTED COIL PROTRUSION WAS POSSIBLY RELATED TO THE ANEURYSM, PROCEDURE AND PENUMBRA SMART COILS. IT IS UNKNOWN WHICH OF THE THREE PREVIOUSLY PLACED SMART COILS PROTRUDED OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6401563 ↗
• InjuryMar 13, 2017Material Protrusion/Extrusion; Unintended Movement; Material Protrusion/Extrusion; Unintended Movement

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, AFTER THE THIRD SMART COIL WAS DEPLOYED AND DETACHED, THE ANGIOGRAPHY SHOWED A PROTRUSION OF A PREVIOUSLY PLACED COIL. THE PHYSICIAN CONTINUED THE PROCEDURE BY PLACING SIX ADDITIONAL SMART COILS. TOWARDS THE END OF THE PROCEDURE, CLOT FORMATION WAS IDENTIFIED ON THE DISPLACED LOOP OF COIL AND AN INTEGRILIN DRIP WAS STARTED. THE PHYSICIAN THEN DECIDED TO PLACE A STENT IN ORDER TO TACK THE PROTRUDING COIL AGAINST THE WALL OF THE VESSEL. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2017. THE REPORTED CLOT FORMATION WAS ADJUDICATED TO HAVE NO RELATIONSHIP TO THE PENUMBRA DEVICES. HOWEVER, THE REPORTED COIL PROTRUSION WAS POSSIBLY RELATED TO THE ANEURYSM, PROCEDURE AND PENUMBRA SMART COILS. IT IS UNKNOWN WHICH OF THE THREE PREVIOUSLY PLACED SMART COILS PROTRUDED OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6401555 ↗