DELTAFILL DLF180312Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886704077190), received between Nov 15, 2017 and Oct 17, 2025 — classified as 5 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (6 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Stretched; Positioning Problem; Material Split, Cut or Torn; Stretched; Positioning Problem; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A RENAL ARTERY ANEURYSM, DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE. THE APPROACH TO THE TARGET SITE WAS MADE VIA DOUBLE CATHETER TECHNIQUE. A PARENT PLUS 45 AND A 2.4 FR LEONIS MOVA MICROCATHETER (SB-KAWASUMI LABORATORIES), 5 FR ANGIOGRAPHIC CATHETER AND A BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC) WERE USED. TWO OF THE MICROCATHETERS WERE ADVANCED INSIDE THE ANEURYSM. THE FRAMING WAS PERFORMED VIA THE LEONIS MOVA USING AN 18MM MICRUSFRAME AND A 16MM MICRUSFRAME. THEN AN ATTEMPT WAS MADE TO PLACE A 16MM X 50CM DELTAFILL 18 (DLF181650 / 1952542S) IN THE ANEURYSM. THE 16MM X 50CM DELTAFILL 18 COIL WAS INSERTED INTO THE MICROCATHETER, BUT IT COULD NOT BE ADVANCED FURTHER DUE TO RESISTANCE. THE INTRODUCER BECAME SPLIT, AND THE DELIVERY WIRE PROTRUDED FROM THE INTRODUCER SHEATH. WHEN THE COIL WAS WITHDRAWN FROM THE MICROCATHETER, IT WAS OBSERVED TO HAVE BECOME UNRAVELED. IT WAS REPLACED WITH A NEW COIL OF THE SAME SIZE (16MM X 50CM). SUBSEQUENTLY, A TOTAL OF 11 COILS INCLUDING COILS FROM OTHER MANUFACTURERS WERE USED AND NO SIMILAR ISSUE OCCURRED. THE 3MM X 12CM D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23325331 ↗
• MalfunctionFeb 5, 2025Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION OF INFERIOR MESENTERIC ARTERY PRIOR TO ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE DELTAFILL18 3MM X 12CM COIL (DLF180312, 30910219) WAS PREPARED AND DELIVERED WITH NO PROBLEMS, BUT THE COIL WAS OVERSIZED AND WAS ATTEMPTED TO BE RETRIEVED. THE COIL COULD NOT BE RE-SHEATHED AND THE COIL AND DELIVERY WIRE COULD NOT BE RETRACTED IN THE INTRODUCER SHEATH, THEREFORE BECAME UNUSABLE. REPLACED WITH ANOTHER NEW DELTA SERIES COIL. THE COIL EMBOLIZATION WAS SUCCESSFULLY COMPLETED WITH DELTA SERIES COILS, WITHOUT FURTHER RE-SHEATHS ATTEMPTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE MARVEL MICROCATHETER (MC), ENPOWERCABLE. ADDITIONAL EVENT INFORMATION RECEIVED ON 29-JAN-2025 INDICATED THAT POOR CONFORMABILITY LED TO RESHEATHING THE COIL. ADDITIONAL EVENT INFORMATION RECEIVED ON 05-FEB-2025 INDICATED THAT THE COIL PROTRUDED AND COULD NOT BE USED. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314544 ↗
• MalfunctionOct 23, 2023Fracture; Difficult to Advance; Fracture; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY (IMA) PRIOR TO STENT GRAFT IMPLANTATION, THE COMPLAINT DEVICES, A 3MM X 12CM DELTAFILL 18 COIL (DLF180312 / 30942954) AND A 150CM X 5CM, 2 MARKERS PROWLER SELECT LPES (606S155X / 30633467) WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). IT WAS REPORTED THAT WHILE INSERTING THE COMPLAINT COIL AS THE 11TH COIL, VIA THE INTRODUCER INTO THE PROWLER SELECT MICROCATHETER, STRONG RESISTANCE WAS FELT INSIDE THE MICROCATHETER. WHEN THE DELIVERY WIRE WAS PULLED, THE COIL WAS FOUND TO HAVE BECOME FRACTURED INSIDE THE MICROCATHETER. THE COIL AND THE MICROCATHETER WERE REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONTINUOUS FLUSH WAS REPORTED AS NOT MAINTAINED DURING THE PROCEDURE. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. ON 11-OCT-2023, LIMITED ADDITIONAL INFORMATION WAS PROVIDED. THE INFORMATION CONFIRMED THAT THE COIL BECAME FRACTURED INSIDE THE MICROCATHETER. ON 18-OCT-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT STRONG RESISTANCE WAS NOT EXPERIENCED WITH THE PREVIOUS COILS. PER THE INFORMATION, CONTINUOUS FLUSH WAS NOT MAINTAINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17991347 ↗
• MalfunctionAug 24, 2023Separation Failure; Premature Separation; Separation Failure; Premature Separation

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION OF THE LUMBAR ARTERIES AND PRIOR TO STENT GRAFT IMPLANTATION FOR ABDOMINAL AORTA ANEURYSM. COIL EMBOLIZATION OF TWO LUMBAR ARTERIES WAS PERFORMED USING GALAXY G3 AND DELTA COILS. NO OTHER COILS WERE USED. USING TOTAL 5 COILS OF GALAXY G3 AND DELTAFILL IN THE FIRST LUMBAR ARTERY. FOR THE SECOND LUMBAR ARTERY, A DELTAFILL18 3MM X 12CM COIL (DLF180312, 30910219) WAS USED AS THE THIRD COIL AND WAS PLACED AND DETACHED. THE THIRD DELTAFILL18 COIL SEEMED TO BE DETACHED WITHOUT ANY PROBLEM UNDER FLUOROSCOPY, BUT WHEN THE COIL WIRE WAS PULLED, THE COIL CAME OUT FROM THE HUB OF THE EXSELSIOR 1018 MICROCATHETER (MC). IT WAS NOT UNRAVELED OR STRETCHED. THE NEXT DELTAFILL COIL OF A DIFFERENT SIZE WAS IMPLANTED WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT CONSEQUENCE. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE INCLUDES AN ENPOWER CONTROL CABLE (ECB000182-00, UNKNOWN LOT). ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. NO NECK REMODELING WAS UTILIZED. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL WAS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17613809 ↗
• MalfunctionMar 30, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A TYPE II ENDOLEAK, AFTER THE GUIDING CATHETER WAS DELIVERED FROM THE LEFT INTERNAL ILIAC ARTERY (IIA) TO THE TYPE II ENDOLEAK, A CARNELIAN® MARVEL® MICROCATHETER (TOKAI MEDICAL) WAS DELIVERED TO THE TARGET LESION AND COIL EMBOLIZATION WAS INITIATED. SEVERAL DELTA COILS WERE IMPLANTED AND ONE OF THE COMPLAINT COILS, A 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208 / 30871979) WAS USED BUT IT BECAME IMPEDED IN THE MICROCATHETER AND WAS UNABLE TO BE DELIVERED. IT WAS REPLACED WITH ANOTHER 2MM X 8CM GALAXY G3 XSFT HELICAL (GLX120208) FROM THE SAME LOT (30871979) BUT THE SAME ISSUE OCCURRED AND THE COIL WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE DELIVERED. IT WAS REPLACED WITH A DELTA COIL (UNSPECIFIED SIZE) AND THIS DELTA COIL WAS DELIVERED TO THE TARGET LESION. IT WAS REPORTED THAT THE LEFT TYPE II ENDOLEAK WAS EMBOLIZED. THE GUIDING CATHETER WAS THEN DELIVERED TO THE TYPE II ENDOLEAK FROM THE RIGHT IIA. THE MICROCATHETER WAS DELIVERED AND COIL EMBOLIZATION WAS INITIATED. 4MM X 15CM DELTA COIL(S) WERE IMPLANTED AND ONE COMPLAINT COIL, A 3MM X 12CM DELTAFILL 18 (DLF180312 / 30810117) WAS USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16650795 ↗
• MalfunctionFeb 9, 2023Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAFILL18 3MM X 12CM COIL (DLF180312, 30803114) WAS ATTEMPTED TO BE INSERTED INTO A MICROCATHETER (PHENOM 17) BUT THERE WAS RESISTANCE FELT SHORTLY AFTER THE COMPLAINT COIL WAS ADVANCED. THE PHYSICIAN THOUGHT THE UNSPECIFIED MICROCATHETER WAS KINKED THEREFORE, THE COIL WAS REMOVED, AND THE PHYSICIAN TRIED AGAIN AFTER THE MICROCATHETER WAS REPLACED WITH ANOTHER MICROCATHETER (SL-10) BUT RESISTANCE OCCURRED AT THE SAME POINT. THERE WAS A POSSIBILITY THAT SOMEWHERE OF THE SHEATH AND THE DELIVERY WIRE GOT STUCK. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL (SAME CATALOG NUMBER) AND THE REPLACEMENT COIL WAS INSERTED. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334827 ↗
• MalfunctionJul 13, 2022Entrapment of Device; Stretched; Difficult to Advance; Premature Separation; Entrapment of Device; Stretched; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A TRANSVENOUS EMBOLIZATION PROCEDURE FOR A DURAL ARTERIOVENOUS FISTULA, THE 3MM X 12CM DELTAFILL 18 COIL (DLF180312 / 30396178) WAS THE 8TH COIL USED. IT WAS REPORTED THAT AT THE TIME OF INDUCTION, THERE WAS SLIGHT RESISTANCE FELT IN THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER), BUT DELIVERY WAS POSSIBLE. THE COMPLAINT COIL WAS INSERTED AS IT IS. THE COIL MASS WAS NOT AGGREGATED AND THE COIL WAS RE-WOUND SEVERAL TIMES. THE COMPLAINT COIL BECAME UNRAVELED DURING THE RE-WINDING. AS THE COIL REMAINED IN THE MICROCATHETER, THE PHYSICIAN ATTEMPTED TO EXTRUDE THE COIL WITH THE GUIDEWIRE BUT WAS NOT SUCCESSFUL. THE COIL WAS REMOVED WITH THE ENTIRE SYSTEM. AFTER THAT, THE PHYSICIAN MADE AN APPROACH WITH THE MICROCATHETER AND AGAIN IMPLANTED SEVEN ADDITIONAL COILS AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT; NO PATIENT ADVERSE EVENT OR PATIENT COMPLICATION REPORTED. ON 12-JUL-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE COMPLAINT COIL HAD NOT BEEN WITHDRAWN AND REPOSITIONED. NO RESISTANCE WAS REPORTED BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15003949 ↗
• MalfunctionMay 24, 2022Entrapment of Device; Separation Failure; Entrapment of Device; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF PULMONARY ARTERIOVENOUS (AVM), THE PHYSICIAN USED A DOUBLE CATHETER TECHNIQUE. DUE TO SLOW PROGRESSION OF THE EXSELSIOR 1018 MICROCATHETER (MC) FROM THE BLOOD VESSEL RUNNING, THE COILING WAS PERFORMED WITH THE STATE THAT THE MICROCATHETER SLIGHTLY APPLIED TENSION, AND THE COMPLAINT PRODUCT, A DELTAFILL18 3MM X 12CM COIL (DLF180312, L17126) WAS USED IN THE LAST STAGE OF THE COILING. THERE WAS AN ATTEMPT TO DETACH THE DELTAFILL18 COIL, THE DETACHMENT BUTTON WAS PRESSED TO CONFIRM DETACHMENT SOUND, AND THE DELIVERY WIRE WAS REMOVED. HOWEVER, THE COIL WAS NOT ABLE TO BE DETACHED, AND IT BECAME CAUGHT WITH OTHER COILS. AFTER THAT, AS THE PHYSICIAN WAS ABLE TO PROCEED WITH THE MICROCATHETER AND CAREFULLY RETURN THE COIL TO THE INSIDE OF THE MICROCATHETER. THE COMPLAINT PRODUCT WAS REMOVED FROM THE PATIENT'S BODY WITH THE MICROCATHETER TOGETHER. AFTER THAT, ANOTHER GALAXY G3 COIL WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT AND THE PATIENT'S CONDITION IS STABLE AFTER THE PROCEDURE. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14487967 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT UNDERWENT A COIL EMBOLIZATION OF A HEMORRHAGIC MONUMENTAL ANEURYSM ON AN UNKNOWN DATE. TRANSARTERIAL EMBOLIZATION (TAE) WAS PERFORMED FOR POSTERIOR GASTRIC ARTERY HEMORRHAGE. THE RIGHT COMMON FEMORAL ARTERY WAS PUNCTURED. A 5F SHEATH WAS INSERTED INTO THE CELIAC ARTERY. CONTRAST IMAGING SHOWED A DEVELOPED AND TORTUOUS POSTERIOR GASTRIC ARTERY. NO OBVIOUS EXTRAVASATION WAS OBSERVED. NO MONUMENTAL TRUNK WAS FOUND, AND ANASTOMOTIC BRANCHES WITH THE GASTROEPIPLOIC ARTERY WERE DEVELOPED. A BALLOON WAS USED TO INSERT THE HEADWAY MICROCATHETER (MICROVENTION) INTO THE POSTERIOR GASTRIC ARTERY WHILE BALLOON OCCLUSION WAS PERFORMED AT THE ORIGIN OF THE CELIAC ARTERY. HOWEVER, BUT THE MICROCATHETER COULD NOT FOLLOW THE HEADWAY. THEREFORE, THE PARENT CATHETER WAS REPLACED WITH ANOTHER ONE (4F) AND IT WAS ADVANCED TO THE PROXIMAL SIDE OF THE POSTERIOR GASTRIC ARTERY. THE MICROCATHETER WAS REPLACED WITH A VELOUTE (ASAHI INTECC) MICROCATHETER AND THE CATHETER WAS INSERTED BEYOND THE TORTUOUS PORTION TO THE ANASTOMOSIS WITH THE MONUMENTAL ARTERY. FIRST, COILING WAS ATTEMPTED WITH A 4MM X 8CM TARGET XL COIL (STRYKER), BUT THE COIL WAS NOT STABLE A

  Patient problems: Perforation of Vessels

  MAUDE report 13483058 ↗
• MalfunctionFeb 2, 2022Material Rupture; Positioning Problem; Material Rupture; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION PROCEDURE FOR MAJOR AORTOPULMONARY COLLATERAL ARTERIES (MAPCA), AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A SHEATH (4FR). AN ANGIO CATHETER WAS ADVANCED TO THE LEFT INTERNAL THORACIC ARTERY (LITA). FROM THERE, A CONCOMITANT MICROCATHETER WAS ADVANCED TOWARD A SHUNT. AFTER IMPLANTING SEVERAL COMPETITIVE COILS, A GALAXY G3 XSFT 2.5MM X 5CM COIL (GLX122505, 30558377) WAS OPENED FOR ADDITIONAL EMBOLIZATION AND INSERTED INTO THE MICROCATHETER. THE PHYSICIAN TOOK OUT THE COIL AND ROLLED IT, BUT IT WAS NOT ABLE TO MAKE A SHAPE AS THE PHYSICIAN INTENDED, AND IT WAS DECIDED TO RE-SHEATH IT ONCE. AT THAT TIME, THE USER TRIED TO RE-SHEATH, BUT EVEN THOUGH THE RE-SHEATH TOOL WAS SLIDING, THE INTRODUCER SHEATH DID NOT RETURN TO ITS ORIGINAL SHAPE, AND THE WIRE WAS EXPOSED MIDWAY. THEREFORE, THE PHYSICIAN STOPPED USING IT AND REMOVED THE ENTIRE DELIVERY SYSTEM FROM THE PATIENT¿S BODY. THE PHYSICIAN TOOK OUT ANOTHER GALAXY G3 COIL OF THE SAME CATALOG NUMBER, AND ROLLED UP IT, AND THIS ONE WAS ROLLED UP AS THE PHYSICIAN WANTED, SO THE PROCEDURE PROCEEDED. THE LITA WAS IMPLANTED WITH THE GALAXY G3 COILS, AND A DELTAFILL18 3MM X 12CM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423317 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, AN (B)(6) YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE, AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN 83MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED TYPE II ENDOLEAK 15 DAYS AFTER THE PROCEDURE; OPEN REINTERVENTION WAS SUBSEQUENTLY PERFORMED. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA; THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 2187 DAYS PRIOR TO THIS PROCEDURE. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. A TOTAL OF THREE (3) 3MM X 12CM DELTAFILL18 COILS (DLF180312 / UNKNOWN LOT NUMBER) WERE IMPLANTED AT THE LUMBAR ARTERY. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THERE WERE NO PROCEDURAL COMPLICATIONS. THE PATIENT WAS HOSPITALIZED TEN DAYS. THE COMPLAINT COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Aneurysm

  MAUDE report 13335140 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE AAA STUDY, AN (B)(6) MALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE, AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN 83MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED TYPE II ENDOLEAK 15 DAYS AFTER THE PROCEDURE; OPEN REINTERVENTION WAS SUBSEQUENTLY PERFORMED. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA; THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 2187 DAYS PRIOR TO THIS PROCEDURE. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. A TOTAL OF THREE (3) 3MM X 12CM DELTAFILL18 COILS (DLF180312 / UNKNOWN LOT NUMBER) WERE IMPLANTED AT THE LUMBAR ARTERY. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THERE WERE NO PROCEDURAL COMPLICATIONS. THE PATIENT WAS HOSPITALIZED TEN DAYS. THE COMPLAINT COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Aneurysm

  MAUDE report 13335135 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE AAA STUDY, AN (B)(6) MALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE, AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN 83MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED TYPE II ENDOLEAK 15 DAYS AFTER THE PROCEDURE; OPEN REINTERVENTION WAS SUBSEQUENTLY PERFORMED. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA; THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 2187 DAYS PRIOR TO THIS PROCEDURE. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. A TOTAL OF THREE (3) 3MM X 12CM DELTAFILL18 COILS (DLF180312 / UNKNOWN LOT NUMBER) WERE IMPLANTED AT THE LUMBAR ARTERY. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THERE WERE NO PROCEDURAL COMPLICATIONS. THE PATIENT WAS HOSPITALIZED TEN DAYS. THE COMPLAINT COILS REMAIN IMPLANTED AND ARE THUS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Aneurysm

  MAUDE report 13335130 ↗
• MalfunctionDec 6, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION FOR AN ARTERIOVENOUS FISTULA (D-AVF), RESISTANCE WAS FELT AT THE TIME OF COIL IMPLANT, SO THE PHYSICIAN ATTEMPTED TO ¿REFURBISH¿ THE 3MM X 12CM DELTAFILL 18 COIL (DLF180312 / 30546454), BUT THE COIL HAD UNRAVELED. THE COMPLAINT COIL WAS REMOVED WITH THE CONCOMITANT SL-10® MICROCATHETER (STRYKER) TOGETHER. IT WAS REPORTED THAT THERE WAS CONTINUOUS FLUSH MAINTAINED THROUGH THE MICROCATHETER. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. THE COMPLAINT PRODUCT IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. ON 28-NOV-2021, ADDITIONAL INFORMATION WAS PROVIDED. THE INFORMATION INDICATED THAT THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THERE WERE NO KINKS ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE UNRAVELING OF THE COMPLAINT COIL; THERE WAS NO ADDITIONAL DAMAGE NOTED ON THE COIL OTHER THAN THE REPORTED UNRAVELED CONDITION. THE REPORTED ISSUE DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12934364 ↗
• MalfunctionSep 21, 2021Failure to Advance; Premature Separation; Failure to Advance; Premature Separation

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION AT THE INFERIOR MESENTERIC ARTERY BEFORE PLACEMENT OF A STENT GRAFT FOR ABDOMINAL AORTIC ANEURYSM. THE COMPLAINT COIL, A DELTAFILL18 3MM X 12CM (DLF180312, 30490114) WAS USED BUT IT GOT STUCK IN A CARNELIAN MICROCATHETER, MARVEL. IT WAS ABOUT TO BE RETRIEVED BUT IT WAS DETACHED IN THE MICROCATHETER (MC). THE CATHETER WAS RETRIEVED TOGETHER, AND A NEW PRODUCT WAS USED FOR EMBOLIZATION. IT WAS UNCLEAR IF CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT REPLACED COIL WAS USED TOGETHER WITH THE MC. NOTHING WAS OBSTRUCTING THE MICROCATHETER. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO MICROCATHETER DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THERE WAS NO DAMAGE TO THE ACTUAL COIL. THERE WAS NO PROLONGATION DURING THE PROCEDURE DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506785 ↗
• MalfunctionMar 27, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE OF A DURAL ARTERIOVENOUS FISTULA (DAVF) WITH THE TARGET ON THE OCCIPITAL ARTERY, THE 3MM X 12CM DELTAFILL 18 COIL (DLF180312 / 30412473) WAS USED, BUT IT WAS NOT ABLE TO BE DETACHED. THE COMPLAINT COIL WAS USED WITH THE ENPOWER DETACHMENT CONTROL BOX (DCB) (CATALOG AND LOT# UNKNOWN) AND THE ENPOWER CONTROL CABLE ((B)(4) / LOT# UNKNOWN). ALL THE CONNECTIONS APPEARED TO FIT WITHOUT APPLICATION OF FORCE. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS RESUMED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11578933 ↗
• MalfunctionJan 12, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN ATTEMPTED TO DETACH A 3MM X 12CM DELTAFILL18 COIL (DLF180312, 30396178) WAS IT FAILED TO DETACH, USING AN ENPOWER CONTROL CABLE (ECB00018200,30424846). THE COMPLAINT CABLE WAS REPLACED WITH ANOTHER CABLE, BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SAME SIZED COIL AND IT WAS DETACHED. THE REPLACED CABLE WAS USED SUCCESSFULLY WITH THE SECOND SAME SIZE COIL THAT DETACHED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THERE WAS NO PROLONGATION IN THE PROCEDURE DUE TO THE EVENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154478 ↗
• MalfunctionApr 14, 2020Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION AT THE SUPERIOR GLUTEAL ARTERY AND THE INFERIOR GLUTEAL ARTERY, THE PACKAGE CONTAINING THE 3MM X 12CM DELTAFILL 18 COIL (DLF180312 / L16201) WAS OPENED, THE COIL WAS NOTED TO BE DETACHED BEFORE THE PHYSICIAN COULD USE IT. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9958826 ↗
• MalfunctionDec 23, 2019Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT GRAFT AT THE INTERNAL ILIAC ARTERY (IIA), THE 3MM X 12CM DELTAFILL 18 (DLF180312 / L15375) WAS USED BUT THERE WAS RESISTANCE BETWEEN THE MICROCATHETER HUB AND THE COIL. THE DELTAFILL 18 WAS RESHEATHED REPEATEDLY, BUT IT BECAME UNRAVELED. ANOTHER DELTAFILL 18 WAS USED AS A REPLACEMENT AND THE PROCEDURE COMPLETED WITH THE IMPLANTATION OF FOURTEEN COILS. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511565 ↗
• MalfunctionOct 29, 2019Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, OF A HEMORRHAGE, A 3MM X 12CM DELTAFILL18 COIL (DLF180312, L14781) WAS USED AS THE SIXTH COIL. AN ELECTRICAL CHECK WAS PERFORMED WITH THE COMPLAINT CABLE, COIL AND MICROCATHETER BUT THE COIL WAS NOT ABLE TO BE DETACHED. THE DETACHMENT BUTTON WAS PRESSED SEVERAL TIMES. THE COIL WAS ATTEMPTED TO BE RE-SHEATHED BUT A GUIDEWIRE WAS NOT ABLE TO BE PULLED OUT. THE PHYSICIAN REMOVED IT WITH THE MICROCATHETER. THE BLOOD FLOW HAD ALMOST STOPPED WITH THE FIFTH COIL AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9250406 ↗
• MalfunctionJul 19, 2019Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE FOR A SUBARACHNOID HEMORRHAGE (SAH), AFTER SEVERAL SPECTRA COILS WERE USED AND IMPLANTED WITHOUT ANY ISSUE, THE 3MM X 12CM DELTAFILL 18 COIL (DLF180312 / L14828) WAS USED BUT THE COIL SIZE DID NOT FIT. THE PHYSICIAN WAS ATTEMPTING TO RESHEATH THE COIL, BUT IT BECAME PREMATURELY DETACHED IN THE HEADWAY® MICROCATHETER (MICROVENTION). THE COIL WAS REMOVED FROM THE PATIENT¿S BODY WITH THE CONCOMITANT MICROCATHETER. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT WITH THE MICROCATHETER TO ACCESS THE TARGET LESION AND AGAIN, SEVERAL COILS WERE USED. THE PROCEDURE WAS COMPLETED WITH THE 4MM X 15CM DELTAFILL 18 COIL. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. THE PRODUCT WAS RETURNED AND IS PENDING EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8809511 ↗
• MalfunctionJun 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF THE MAJOR AORTOPULMONARY COLLATERAL ARTERIES (MAPCA) AT THE COLLATERAL CIRCULATION COMING FROM THE RIGHT INTERNAL MAMMARY ARTERY, A 4MM X 12CM GALAXY G3 COIL (GLY120412, L12742) WAS USED, BUT THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. THEREFORE, IT WAS REPLACED WITH ANOTHER GALAXY G3 COIL. THEN, THE COIL OF A 3MM X 12CM DELTAFILL 18 (DLF180312, L13558) PREMATURELY DETACHED INSIDE THE SHEATH INTRODUCER. THEREFORE, THIS COIL WAS ALSO REPLACED WITH ANOTHER COIL. THERE WAS NO REPORTED PATIENT INJURY AND THE PROCEDURE WAS COMPLETED. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717416 ↗
• InjuryJun 5, 2019Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TO TARGETING AN ANEURYSM ON THE STENOSED CORONARY ARTERY OF THE (B)(6) MALE PATIENT, AN UNSPECIFIED BALLOON CATHETER WAS INFLATED IN THE STENOSED TARGET LESION AND A BARE STENT WAS IMPLANTED. A PROGREAT® MICROCATHETER (TERUMO) WAS USED BUT IT COULD NOT BE ADVANCED TO THE LESION; IT WAS REPLACED WITH THE 150CM X 5CM PROWLER SELECT LPES, 45 DEG TIP MICROCATHETER (606S155FX / 30161573) AND THE COIL EMBOLIZATION WAS INITIATED. THE 3MM X 12CM DELTAFILL 18 COIL (DLF180312 / L15212) WAS THE THIRD COIL CHOSEN; IT WAS INSERTED INTO THE MICROCATHETER, BUT THERE WAS RESISTANCE BETWEEN THE COIL AND THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, BUT THE COIL BECAME UNRAVELED. THE COIL DID NOT DETACH NOR SEPARATE. THE PHYSICIAN THEN CUT THE HUB OF THE MICROCATHETER WITH THE COIL INSIDE OF IT, THE COIL WAS REMOVED USING A SNARE CATHETER. THE MICROCATHETER AND THE COIL WERE REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE IMPLANTATION OF THREE ADDITIONAL COILS. THERE WAS NO KNOWN PATIENT COMPLICATION AS A RESULT OF THE EVENT. IT WAS REPORTED THAT THE PRODUCT IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Code Available

  MAUDE report 8672704 ↗
• MalfunctionNov 2, 2018Off-Label Use; Separation Failure; Material Twisted/Bent; Off-Label Use; Separation Failure; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BRONCHIAL-INTERCOSTAL ARTERY, THE FIFTH SPECTRA COIL FAILED TO DETACH IN THE TARGET LESION. SEVERAL ATTEMPTS WERE MADE TO DETACH THE COIL WITHOUT SUCCESS; THEREFORE, THE ENPOWER CONTROL CABLE (ECB000182-00/S14572) WAS REPLACED AND THE COIL WAS DETACHED SUCCESSFULLY. THE 3MM X 12CM DELTAFILL18 (DLF180312/S14732) THERMO-MECHANICAL COIL WAS THEN CONNECTED TO THE CONTROL CABLE, BUT THE POWER LAMP DID NOT ILLUMINATE. THE COIL WAS REPLACED. TWO ADDITIONAL SPECTRA COILS WERE PLACED. THE 3MM X 6CM DELTAXTRASOFT (DLX100306/S14197) THERMO-MECHANICAL COIL WAS THEN INSERTED INTO THE PATIENT, BUT THE COIL FAILED TO BE DETACHED DESPITE MULTIPLE ATTEMPTS. THE POWER LAMP WAS ON AND THE CONTROL CABLE WAS NEW. THE COIL WAS REPLACED WITH A SAME-SIZED COIL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE COIL D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8033450 ↗
• MalfunctionAug 15, 2018Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TO TREAT AN UNRUPTURED ANEURYSM IN A (B)(6) FEMALE PATIENT, DURING THE DELIVERY OF THE DELTAFILL 18 3 MM X 12 CM COIL (DLF180312 / L10330), THE COIL PREMATURELY DETACHED BEFORE IT WAS FULLY INSERTED INTO THE ANEURYSM. THE PHYSICIAN WAS ABLE TO PUSH THE COIL INTO THE ANEURYSM USING THE COIL DELIVERY WIRE AND THE COIL WAS IMPLANTED. THE EVENT DID NOT RESULT IN ANY CLINICAL DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7786975 ↗