Smart Coil 400SMTSFT0408Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00814548015088), received between Dec 9, 2015 and Nov 9, 2021 — classified as 6 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (11 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN USED FORCEPS TO DETACH THE SMART COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, A NON-PENUMBRA CATHETER AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783702 ↗
• MalfunctionNov 9, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY USING PENUMBRA SMART COILS (SMART COIL), NON-PENUMBRA COILS, AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR NON-PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A SMART COIL PAST THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SMART COIL WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE SMART COIL WAS RETRACTED AND REMOVED. IT WAS REPORTED THAT THE MICROCATHETER WAS FLUSHED INTERMITTENTLY. THE PROCEDURE WAS COMPLETED USING THREE SMART COILS, TWO NON-PENUMBRA COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783032 ↗
• MalfunctionJul 1, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COIL (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL; HOWEVER, WHILE RETRACTING, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY TO PUSH THE DETACHED SMART COIL INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100111 ↗
• MalfunctionJan 9, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED FOUR SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. AFTERWARDS, FOUR SMART COILS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE FOUR SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11144081 ↗
• MalfunctionDec 23, 2020Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE HANDLE WAS REMOVED AND SAVED FOR LATER USE. THE PHYSICIAN MADE ANOTHER ATTEMPT TO DETACH THE SMART COIL USING A NEW HANDLE, BUT THE SMART COIL STILL FAILED TO DETACH. THEREFORE, THE PHYSICIAN USED A HEMOSTAT ON THE BACK OF THE PUSHER ASSEMBLY TO MANUALLY DETACH THE SMART COIL. NEXT, ANOTHER SMART COIL WAS ADVANCED INTO THE VESSEL AND THE PHYSICIAN ATTEMPTED TO DETACH IT USING BOTH HANDLES; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE COIL STILL FAILED TO DETACH. THEREFORE, BOTH HANDLES AND THE SMART COIL WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11066894 ↗
• MalfunctionNov 26, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED SIX NON-PENUMBRA COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. AFTERWARDS, THE PHYSICIAN ADVANCED A SMART COIL INTO THE TARGET LOCATION USING THE MICROCATHETER AND DETACHED IT USING THE HANDLE. WHILE RETRACTING THE PUSHER ASSEMBLY OF THE SMART COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE SMART COIL BECAME STUCK WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER AND THE PUSHER ASSEMBLY OF THE SMART COIL WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL SMART COIL, THE SAME HANDLE, AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10909161 ↗
• MalfunctionOct 9, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PUSH A SMART COIL THROUGH THE FRICTION LOCK OF THE INTRODUCER SHEATH. THE SAME ISSUE OCCURRED WITH TWO OTHER SMART COILS. THE PHYSICIAN PULLED THE THREE SMART COILS BACKWARDS OUT OF THE INTRODUCER SHEATH, CUT THE FRICTION LOCK, AND ADVANCED THE SMART COILS INTO THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING THE SAME SMART COILS AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10658826 ↗
• MalfunctionSep 3, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), NON-PENUMBRA COILS, AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A SMART COIL IN THE TARGET VESSEL USING THE FIRST MICROCATHETER AND TWO OTHER COILS USING THE SECOND MICROCATHETER. WHILE RETRACTING THE PUSHER ASSEMBLY OF THE IMPLANTED SMART COIL THROUGH THE PROXIMAL END OF THE PHENOM, THE PUSHER ASSEMBLY TIP SUDDENLY BECAME STUCK. THEREFORE, THE FIRST MICROCATHETER CONTAINING THE STUCK PUSHER ASSEMBLY WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE NON-PENUMBRA COILS AND THE SAME SECOND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10491773 ↗
• MalfunctionJul 30, 2020Separation Problem; Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL USING THE MICROCATHETER AND MADE TWO ATTEMPTS TO DETACH THE SMART COIL USING THE HANDLE. HOWEVER, THE HANDLE FAILED TO DETACH THE SMART COIL. SUBSEQUENTLY, A HEMOSTAT WAS USED TO MANUALLY DETACH THE SMART COIL. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10345152 ↗
• MalfunctionDec 3, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED TWO SMART COILS IN THE TARGET VESSEL AFTER MAKING MULTIPLE ATTEMPTS IN DETACHING THE COILS USING THE HANDLE. WHILE ATTEMPTING TO PLACE TWO MORE SMART COILS USING A SECOND HANDLE, THE PHYSICIAN AGAIN MADE MULTIPLE ATTEMPTS IN DETACHING THE COILS USING THE HANDLE. ALL FOUR COILS WERE PLACED SUCCESSFUL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405998 ↗
• MalfunctionAug 9, 2019Failure to Fold; Physical Resistance/Sticking; Failure to Fold; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED FIVE SMART COILS IN THE ANEURYSM. THE PHYSICIAN EXPERIENCED SEVERAL CATHETER KICKBACKS WHILE DELIVERING MULTIPLE SMART COILS INTO THE ANEURYSM. THE PHYSICIAN ADVANCED A NEW SMART COIL IN THE ANEURYSM; HOWEVER, THE COIL DID NOT FORM CORRECTLY IN THE ANEURYSM AND WAS REMOVED FROM THE PATIENT. THE SAME INCIDENT OCCURRED WITH A SECOND SMART COIL. THE PHYSICIAN NOTED THAT WHEN REMOVING THE TWO SMART COILS, THERE WAS AN UNCOMFORTABLE GRITTINESS. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881091 ↗
• MalfunctionJun 18, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED A SMART COIL USING A NON-PENUMBRA MICROCATHETER. WHILE RETRACTING TO REMOVE THE PUSHER ASSEMBLY, THE PHYSICIAN FELT RESISTANCE AND THE PUSHER ASSEMBLY BECAME "HUNG UP" AT THE TIP OF THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE PUSHER ASSEMBLY BUT FOUND THAT THE TIP WAS DAMAGED AND A LITTLE PIECE WAS "FLARED UP". THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707849 ↗
• MalfunctionMar 20, 2019Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ADVANCED A SMART COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER AND USED THE HANDLE TO DETACH IT. THE PHYSICIAN THEN ADVANCED A NEW SMART COIL INTO THE TARGET VESSEL, BUT WAS UNABLE TO DETACH THE COIL USING THE HANDLE. AFTER MULTIPLE FAILED ATTEMPTS, A NEW HANDLE WAS OPENED AND USED TO SUCCESSFULLY DETACH THE SAME SMART COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING THE SAME NEW HANDLE, FOUR SMART COILS, TWO OTHER COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436115 ↗
• MalfunctionNov 16, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO A NON-PENUMBRA MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY ADVANCED ANOTHER SMART COIL IN THE TARGET VESSEL. NEXT, ANOTHER SMART COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8081819 ↗
• MalfunctionOct 24, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE A SMART COIL THROUGH ITS INTRODUCER SHEATH AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL, ADDITIONAL COILS, AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8000635 ↗
• MalfunctionSep 5, 2018Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A SMART COIL WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN ATTEMPTED TO SLIGHTLY RETRACT AND RE-ADVANCE THE SMART COIL, HOWEVER, THE SMART COIL WAS STUCK. THE SMART COIL WAS, THEREFORE, REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7848748 ↗
• MalfunctionAug 31, 2018Difficult or Delayed Activation; Difficult or Delayed Separation; Difficult or Delayed Activation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL AND USED A HANDLE TO DETACH IT; HOWEVER, THE DETACHMENT ZONE WAS NOT SEPARATED. THE PHYSICIAN THEN MADE A COUPLE MORE ATTEMPTS AND THE SMART COIL WAS SUCCESSFULLY DETACHED AFTER THE THIRD ATTEMPT. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND THE SECOND SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837820 ↗
• MalfunctionAug 31, 2018Difficult or Delayed Activation; Difficult or Delayed Separation; Difficult or Delayed Activation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL AND USED A HANDLE TO DETACH IT; HOWEVER, THE DETACHMENT ZONE WAS NOT SEPARATED. THE PHYSICIAN THEN MADE A COUPLE MORE ATTEMPTS AND THE SMART COIL WAS SUCCESSFULLY DETACHED AFTER THE THIRD ATTEMPT. NEXT, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND THE SECOND SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7837774 ↗
• MalfunctionJul 31, 2018Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN WAS UNABLE TO REMOVE A PENUMBRA SMART COIL (SMART COIL) OUT OF ITS DISPENSER HOOP; THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7735764 ↗
• InjuryJul 25, 2018Malposition of Device; Malposition of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CEREBRAL ARTERY (ACA) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE FIRST SMART COIL IN THE ANEURYSM LUMEN, THE SMART COIL KEPT HERNIATING INTO THE ANTERIOR COMMUNICATING ARTERY (ACOM). AFTER SEVERAL ATTEMPTS IT WAS NOTED THAT A SMALL THROMBUS ON THE COIL TIP HAD FORMED, CAUSING A STROKE. THEREFORE, THE SMART COIL WAS REMOVED AND 10 MG REOPRO INTRAVENOUS (IV) WAS INFUSED TO START. THE PHYSICIAN THEN PERFORMED A THROMBECTOMY PROCEDURE TO TREAT THE STROKE. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY (B)(6) 2018. THE STROKE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT TO THE PATIENT WITH DEFINITE RELATIONSHIP TO THE SMART COIL SYSTEM AND UNRELATED TO THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 7720455 ↗
• MalfunctionJul 19, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE SMART COIL BECAME STUCK AFTER GETTING INSIDE THE HUB OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN PLACED TWO OTHER COILS IN THE TARGET VESSEL USING THE SAME MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL ALSO BECAME STUCK AT THE SAME POSITION AS THE FIRST SMART COIL; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704711 ↗
• MalfunctionJul 17, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A SMART COIL. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A SMART COIL AT ALL WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695534 ↗
• MalfunctionJul 2, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A SMART COIL INTO THE HUB OF A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL TIP OF THE SMART COIL INTRODUCER SHEATH; THEREFORE, THE SMART COIL WAS REMOVED. UPON REMOVAL, THE PHYSICIAN INSPECTED THE SMART COIL ON THE BACK TABLE AND NOTICED THAT IT WOULD NOT ADVANCE OUT OF THE TIP OF ITS INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL, OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7655430 ↗
• InjuryApr 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A BALLOON ASSISTED COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS) WITH NO REPORTED COMPLICATIONS. ON (B)(6) 2017, THE PATIENT EXPERIENCED AN ISCHEMIC STROKE AND PRESENTED TO THE EMERGENCY ROOM (ER) WITH LEFT UPPER EXTREMITY NUMBNESS AND WEAKNESS. IT WAS REPORTED THAT THE PATIENT WAS ON WARFARIN FOR STROKE PREVENTION WITH ATRIAL FIBRILLATION BUT HELD HER THERAPY ONE WEEK PRIOR FOR THREE DAYS, FOR A COLONOSCOPY. THEREFORE, THE PATIENT RECEIVED INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) AND WAS ADMITTED TO THE NEUROLOGICAL INTENSIVE CARE UNIT (ICU). THE PATIENT¿S MEDICATION WAS ALSO SWITCHED TO ELIQUIS AND ASPIRIN AND THE STROKE RESOLVED. ON (B)(6) 2017, THE PATIENT WAS DISCHARGED TO INPATIENT REHAB. THE REPORTED ISCHEMIC STROKE WAS ADJUDICATED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PENUMBRA SMART COIL SYSTEM AND THE PROCEDURE.

  Patient problems: Ischemia; Numbness; Weakness

  MAUDE report 7408240 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIVE SMART COIL AND A NON-PENUMBRA STENT. DURING THE PROCEDURE THERE WAS THROMBUS FORMATION, AND THEREFORE THE HOSPITAL STAFF IMMEDIATELY ADMINISTERED THROMBOLYTICS INTRA-ARTERIALLY. THERE WAS COMPLETE RESTORATION OF FLOW, AND THE PATIENT DEMONSTRATED NO NEW RESIDUAL NEUROLOGIC DEFICITS FROM THIS EVENT. THIS ADVERSE EVENT WAS RESOLVED. THE THROMBUS FORMATION WAS ADJUDICATED TO HAVE A PROBABLE RELATIONSHIP TO THE SMART COIL SYSTEM.

  Patient problems: Thrombus

  MAUDE report 7339858 ↗