DELTAFILLRecalls & reported problems across all models

We found 29 models of DELTAFILL by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 294 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2016 and Sep 28, 2026 — classified as 41 injuries, 253 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (57 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DELTAFILL problems

DELTAFILL models

29 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DELTAFILL DLF180415

  Device, Vascular, for Promoting Embolization
  32 reports
• DELTAFILL DLF180625

  Device, Vascular, for Promoting Embolization
  30 reports
• DELTAFILL DLF181040

  DEVICE, NEUROVASCULAR EMBOLIZATION
  30 reports
• DELTAFILL DLF180312

  Device, Vascular, for Promoting Embolization
  29 reports
• DELTAFILL DLF180835

  DEVICE, NEUROVASCULAR EMBOLIZATION
  22 reports
• DELTAFILL DLF182060

  Device, Vascular, for Promoting Embolization
  17 reports
• DELTAFILL DLF180733

  Device, Vascular, for Promoting Embolization
  15 reports
• DELTAFILL DLF181650

  Device, Vascular, for Promoting Embolization
  14 reports
• DELTAFILL DLF182460

  Device, Vascular, for Promoting Embolization
  13 reports
• DELTAFILL DLF180520

  Device, Vascular, for Promoting Embolization
  12 reports
• DELTAFILL DLF181242

  Device, Vascular, for Promoting Embolization
  11 reports
• DELTAFILL DLF100208

  Device, Vascular, for Promoting Embolization
  7 reports
• DELTAFILL DLF182260

  Device, Vascular, for Promoting Embolization
  7 reports
• DELTAFILL DLF100515

  Device, Vascular, for Promoting Embolization
  6 reports
• DELTAFILL DLF181855

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• DELTAFILL DLF100820

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• DELTAFILL DLF181445

  Device, Vascular, for Promoting Embolization
  5 reports
• DELTAFILL DLF100925

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• DELTAFILL DLF100308

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• DELTAFILL DLF100154

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• DELTAFILL DLF100408

  Device, Vascular, for Promoting Embolization
  3 reports
• DELTAFILL DLF100616

  Device, Vascular, for Promoting Embolization
  3 reports
• DELTAFILL DLF180935

  Device, Vascular, for Promoting Embolization
  3 reports
• DELTAFILL DLF100720

  Device, Vascular, for Promoting Embolization
  3 reports
• DELTAFILL DLF100410

  Device, Vascular, for Promoting Embolization
  2 reports
• DELTAFILL DLF100510

  Device, Vascular, for Promoting Embolization
  2 reports
• DELTAFILL DLF100612

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• DELTAFILL DLF100250

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAFILL DLF100310

  Device, Vascular, for Promoting Embolization
  1 report

Recent DELTAFILL adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break; Device Difficult to Setup or Prepare; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926013 ↗
• MalfunctionJun 12, 2026Material Rupture; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF A PULMONARY ARTERY TO TREAT A PULMONARY ARTERIOVENOUS FISTULA, THE 22MM X 60CM DELTAFILL 18 COIL (DLF182260 / 2232574S) WAS PREPARED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU). DURING USE, IT WAS REPORTED THAT RESISTANCE WAS FELT AT THE DISTAL TIP OF THE INTRODUCER. THE COIL DID NOT EXIT FROM THE TIP. WHEN THE DELIVERY WIRE WAS ADVANCED, THE COIL AND THE FLEXIBLE PORTION OF THE WIRE DEVIATED FROM THE SHEATH. THE COIL COULD NOT BE USED, AND IT WAS REPLACED WITH ANOTHER COIL OF THE SAME SIZE AND SPECIFICATIONS. TH PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT. CONTINUOUS FLUSH WAS MAINTAINED. THE ASSOCIATED MICROCATHETER USED WAS A LEONIS MOVA MICROCATHETER (SB-KAWASUMI LABORATORIES) THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE PRODUCT INVESTIGATION COMPLETED ON 12-JUN-2026. BASED ON THE COMPLETED PRODUCT INVESTIGATION, THIS EVENT HAS BEEN DETERMINED TO BE USFDA REPORTABLE UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25493946 ↗
• MalfunctionMay 26, 2026Product Quality Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY OF SPLENIC ARTERY TO TREAT SPLENIC ARTERY ANEURYSM; AFTER APPROACHING THE TARGET LESION, COIL EMBOLIZATION OF THE SPLENIC ARTERY ANEURYSM WAS INITIATED. THE 4MM X 15CM DELTAFILL 18 (DLF180415 / 31073003) WAS DELIVERED THROUGH THE PROWLER SELECT PLUS MICROCATHETER WITHOUT ¿ANY FEELING OF STRANGENESS; HOWEVER, THE COIL COULD NOT BE VISUALIZED UNDER FLUOROSCOPY.¿ THE DELTAFILL 18 COIL WAS WITHDRAWN AND VISUALLY INSPECTED OUTSIDE THE PATIENT¿S BODY, BUT THE COIL WAS STILL NOT LOCATED. IT WAS THEN REPORTED THAT, ¿CONSIDERING THE POSSIBILITY THAT THE COIL HAD FRACTURED WITHIN THE MICROCATHETER, THE MICROCATHETER WAS REMOVED AND INSPECTED OUTSIDE THE PATIENT¿S BODY; HOWEVER, THE COIL WAS NOT FOUND INSIDE THE MICROCATHETER.¿ THE DELTAFILL 18 COIL WAS REPLACED WITH A NEW COIL AND THEN THE SAME MICROCATHETER WAS USED. NO FURTHER ISSUES OCCURRED. CONTINUOUS FLUSH WAS MAINTAINED. THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT.ON 18-MAY-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN INVOLVED IN THE PROCEDURE WAS INTERVIEWED AND REPORTED THE SITUATION AS FOLLOWS: ¿AS THE COIL WAS NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284384 ↗
• MalfunctionMay 19, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A COIL EMBOLIZATION OF INFERIOR MESENTERIC ARTERY AND LUMBAR ARTERY PRIOR TO STENT GRAFT IMPLANTATION TO TREAT ABDOMINAL AORTIC ANEURYSM. AFTER EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY USING J&J COILS, EMBOLIZATION OF THE LUMBAR ARTERY WAS PERFORMED. AN ATTEMPT WAS MADE TO DEPLOY THE A DELTAFILL18 20MM X 60CM COIL (PRODUCT CODE: DLF182060, LOT NUMBER: 3422537S). HOWEVER, DETACHMENT WAS NOT POSSIBLE. THERE WERE NO ISSUES OBSERVED WITH THE CONTROL BOX, INCLUDING INDICATOR LIGHTS. SINCE COIL DETACHMENT HAD BEEN PERFORMED WITHOUT ANY PROBLEMS DURING EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY, THE ISSUE WAS CONSIDERED TO BE RELATED TO THE DELTAFILL18 COIL. THE DELTAFILL18 WAS THEREFORE WITHDRAWN AND REPLACED WITH ANOTHER NEW COIL OF THE SAME SPECIFICATION. THE REPLACEMENT COIL FUNCTIONED WITHOUT ANY PROBLEMS. THERE WAS NO DELAY THAT IMPACTED CLINICAL PRACTICE. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICE WAS COILINGSUPPORT MICROCATHETER. A 4 FR ANGIOGRAPHIC CATHETER COMBINED WITH COILING SUPPORT (MEDICOS HIRATA) SYSTEM WAS USED. THE DEVICES WERE USED ACCORDING TO THE INSTRUCT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216199 ↗
• MalfunctionMay 12, 2026Stretched; Difficult to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS AN ENDOVASCULAR EMBOLIZATION OF A SPLENIC ARTERY ANEURYSM, THE EMBOLIZATION OF SPLENIC ARTERY ANEURYSM WAS PERFORMED USING A 4FR ANGIOGRAPHIC CATHETER AND LIGHTHOUSE MICROCATHETER (MC). AFTER FRAMING WITH A TARGET XXL (STRYKER), THE USER INITIATED FILLING USING DLF COILS. AFTER USING ONE 18MM AND ONE 12MM COIL, THE USER ATTEMPTED TO PLACE A DELTAFILL18 10MM X 40CM (PRODUCT CODE: DLF181040, LOT NUMBER: 0282601S). THE PHYSICIAN NOTED STIFFNESS WHEN PLACING THE COIL COMPARED WITH USUAL. CONSIDERING THE POSSIBILITY THAT THE MICROCATHETER POSITION WAS NOT PROPER, RE-SHEATHED THE COIL AND ADJUSTED THE MICROCATHETER POSITION TWICE. WHILE ADVANCING AND RE-SHEATHING THE COIL THEREAFTER, IT UNRAVELED. THE DELTAFILL COIL WAS RETRIEVED WITH THE MICROCATHETER AND THE WHOLE SYSTEM WAS CHANGED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR¿S COIL. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149806 ↗
• MalfunctionApr 9, 2026Device Difficult to Setup or Prepare; Stretched; Difficult to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF THE SPLENIC ARTERY ANEURYSM, THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS STRONG RESISTANCE WAS FELT WITH A DELTA FILL 18 DELTA FILL 18 X 35CM (PRODUCT CODE: DLF180835, LOT NUMBER: 2592511S) WHICH WAS USED AS THE FIFTH COIL. THE COIL ATTEMPTED TO BE RE-SHEATHED, BUT COULD NOT. ADDITIONAL EVENT INFORMATION RECEIVED ON 07-APR-2026 INDICATED THAT THE INTRODUCER WAS NOT DAMAGED IN ANY WAY. THE EMBOLIC OIL WAS UNRAVELED. THERE WAS NO EXCESSIVE FORCE DURING UNSHEATHING OR RE-SHEATHING. THERE WAS NO DIFFICULTIES PREPPING THE DELIVERY SYSTEM. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THE EMBOLIC COIL WAS STILL ATTACHED TO THE DELIVERY WIRE WHEN REMOVED FROM THE PATIENT AND WAS PARTIALLY UNRAVELED. THE UNRUPTURED ANEURYSM MEASURED 18¿19 MM IN DIAMETER AND HAD A WIDE NECK. THEREFORE, THE MICROCATHETER HAD TO BE DEEPLY ENGAGED, MAKING THE SITUATION DIFFICULT TO ASSESS, SUCH AS WHETHER THE INTERMEDIATE CATHETER WAS PROTRUDING BEYOND THE MICROCATHETER TIP. AS A RESULT, THE COIL WAS LIKELY UNDER TENSION AT THE MICROCATHETER TIP, AND THE PHYSICIAN COULD NOT IMMEDIATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24833062 ↗
• MalfunctionApr 6, 2026Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT UPON OPENING THE PACKAGE OF DELTAFILL18 COIL (PRODUCT CODE: DLF180835, LOT NUMBER 2232558S) THE DELIVERY WIRE AND SHEATH WERE FOUND TO BE TORN, RENDERING THE DEVICE UNUSABLE. THE DEVICE WAS DISCARDED. THERE WAS NO VISIBLE DAMAGE TO THE OUTER BOX OR OTHER PACKAGING. THE DELTAFILL18 WAS REPLACED WITH ANOTHER NEW DEVICE OF THE SAME SPECIFICATION, WHICH WAS SUCCESSFULLY IMPLANTED. PATIENT IMPACT: NO ADVERSE EVENTS OR NEGATIVE CLINICAL IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790672 ↗
• MalfunctionMar 26, 2026Stretched; Difficult to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF THE SPLENIC ARTERY ANEURYSM, THE DEVICES WERE USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS PERFORMED USING THE TRIPLE COAXIAL TECHNIQUE WITH LEONIS HF AND BREAKTHROUGH. CONTINUOUS FLUSHING WAS MAINTAINED, BUT WHEN ATTEMPTING TO DELIVER THE DELTAFILL18 18 16MM X 50CM (PRODUCT CODE: DLF181650, LOT NUMBER 2952502S) INTO THE MICROCATHETER, STRONG RESISTANCE WAS ENCOUNTERED, AND THE COIL ALONG WITH BREAKTHROUGH MICROCATHETER (MC) WERE WITHDRAWN FROM THE PATIENT¿S BODY AS A SINGLE UNIT. VISUAL INSPECTION CONFIRMED AN UNRAVELING OF THE DELTAFILL18 18 16MM X 50CM, SO IT WAS REPLACED WITH FRAMES WHICH WAS IMPLANTED. THE PROCEDURE WAS CONTINUED WITH SMALLER SIZED COILS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. OTHER CONCOMITANT DEVICES WERE LEONISMOVA INTERMEDIATE CATHETER, ENPOWER CABLE, AND BREAKTHROUGH MICROCATHETER. ADDITIONAL EVENT INFORMATION RECEIVED ON 12-MAR-2026 INDICATED THAT COIL UNRAVELING OCCURRED WHILE THE ADJUNCTIVE CATHETER STILL CONTAINED THE COIL, ALTHOUGH MOST OF THE COIL REMAINED INSIDE THE ANEURYSM. THE PHYSICIAN COMMENTED THAT HE FELT AS IF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698510 ↗
• MalfunctionFeb 23, 2026Fracture; Difficult to Advance

  DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL ILIAC ARTERY TRUNK TO TREAT AN INTERNAL ILIAC ARTERY ANEURYSM, DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). THE PROCEDURE WAS PERFORMED USING A 4FR ANGIOGRAPHIC CATHETER (UNSPECIFIED BRAND) AND A PROWLER SELECT PLUS STRAIGHT MICROCATHETER. AFTER EMBOLIZING THE SUPERIOR AND INFERIOR GLUTEAL ARTERIES WITH MICRUSFRAME AND DELTAFILL COILS, EMBOLIZATION OF THE MAIN TRUNK WAS PERFORMED. DURING THE ATTEMPT TO USE THE 12MM X 42CM DELTAFILL 18 (DLF181242 / 2612521S) AS THE FIRST COIL, RESISTANCE WAS FELT AT THE PROXIMAL PORTION INSIDE THE MICROCATHETER. THE PHYSICIAN MANAGED TO ADVANCE THE COIL, BUT THE RESISTANCE WAS STRONG AND THE DELIVERY WIRE BROKE AT A THIN SECTION. THE PHYSICIAN SPLIT THE SHEATH UP TO THE BROKEN SECTION AND ATTEMPTED TO ADVANCE THE COIL, BUT IT WAS DIFFICULT. THE 12MM X 42CM DELTAFILL 18 WAS RETRIEVED. ANOTHER COIL FROM A DIFFERENT LOT OF THE SAME SPECIFICATIONS WAS USED AND DELIVERY WAS COMPLETED WITHOUT ANY RESISTANCE. IT WAS REPORTED AFTER PLACING ONE COIL OF THE SAME SPECIFICATION, ANOTHER 12MM X 42CM DELTAFILL 18 (DLF181242) FROM THE SAME LOT (2612521S) WAS INSERTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415879 ↗
• MalfunctionFeb 19, 2026Failure to Advance

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, TWO DELTAFILL10 2MM X 8CM COILS (PRODUCT CODES: DLF100208, LOT NUMBERS 2232554S AND 2232541S) AND A DELTAXSFT10 2MM X 4CM COIL (PRODUCT CODE: DLX100204, LOT NUMBER: 2022553S) COULD NOT BE INSERTED INTO THE ECHELON10, MEDTRONIC MICROCATHETER (MC). ADDITIONAL EVENT INFORMATION INDICATED THAT ANOTHER DELATAFILL AND DELTAXSFT COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER. THERE WAS NO NEED TO REMOVE OR REPLACE THE MICROCATHETER DURING THE PROCEDURE. THE TARGET VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA), AND SPECIFIC ANATOMICAL CHARACTERISTICS¿INCLUDING CALCIFICATION, TORTUOSITY, AND VESSEL DIAMETER¿WERE NOT AVAILABLE. THROUGHOUT THE INTERVENTION, THERE WERE NO OBSERVATIONS OF PHYSICAL DAMAGE TO THE DEVICES, AND NO OBSTRUCTIONS WITHIN THE MICROCATHETER WERE NOTED. A CONTINUOUS FLUSH WAS MAINTAINED FOR THE DURATION OF THE PROCEDURE. BASED ON THE PRODUCT ANALYSIS OF THE RETURNED DEVICE, THE EMBOLIC STENT WAS PREMATURLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393049 ↗
• MalfunctionFeb 19, 2026Failure to Advance

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, TWO DELTAFILL10 2MM X 8CM COILS (PRODUCT CODES: DLF100208, LOT NUMBERS: 2232554S AND 2232541S) AND A DELTAXSFT10 2MM X 4CM COIL (PRODUCT CODE: DLX100204, LOT NUMBER: 2022553S) COULD NOT BE INSERTED INTO THE ECHELON10, MEDTRONIC MICROCATHETER (MC). ADDITIONAL EVENT INFORMATION INDICATED THAT ANOTHER DELATAFILL AND DELTAXSFT COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER. THERE WAS NO NEED TO REMOVE OR REPLACE THE MICROCATHETER DURING THE PROCEDURE. THE TARGET VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA), AND SPECIFIC ANATOMICAL CHARACTERISTICS¿INCLUDING CALCIFICATION, TORTUOSITY, AND VESSEL DIAMETER¿WERE NOT AVAILABLE. THROUGHOUT THE INTERVENTION, THERE WERE NO OBSERVATIONS OF PHYSICAL DAMAGE TO THE DEVICES, AND NO OBSTRUCTIONS WITHIN THE MICROCATHETER WERE NOTED. A CONTINUOUS FLUSH WAS MAINTAINED FOR THE DURATION OF THE PROCEDURE. BASED ON THE PRODUCT ANALYSIS OF THE RETURNED DEVICE, THE EMBOLIC STENT WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392938 ↗
• MalfunctionJan 30, 2026Entrapment of Device; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF A GASTRIC VEIN WITH BALLOON OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) USING A 4 FR ANGIOGRAPHIC CATHETER AND AN EXCELSIOR® 1018® MICROCATHETER (STRYKER), DEVICES WERE USED IN ACCORDANCE WITH THEIR INSTRUCTIONS FOR USE (IFUS), THE FIRST TWO COILS USED WERE TARGET¿ XXL 24MM COILS (STRYKER) AND FRAMING WERE PERFORMED AFTER WHICH THE PHYSICIAN ATTEMPTED TO PLACE THE 24MM X 60CM DELTAFILL 18 (DLF182460 / 2862563S). IT WAS REPORTED THAT ¿BECAUSE IT WOULD NOT BE WOUND PROPERLY, [THE PHYSICIAN] ATTEMPTED TO REMOVE THE 24MM X 60CM DELTAFILL 18 COIL, BUT IT UNRAVELED.¿ THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT¿S BODY, AND A RE-APPROACH WAS MADE AND A NEW DELTAFILL COIL OF DIFFERENT SPECIFICATIONS WAS DEPLOYED. AFTERWARDS, COILS FROM A DIFFERENT MANUFACTURER WERE USED AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 23-JAN-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE COIL WAS NOT DETACHED WHEN IT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225127 ↗
• MalfunctionNov 19, 2025Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF AN INTERNAL ILIAC ARTERY PRIOR TO ENDOVASCULAR AORTIC REPAIR (EVAR) TO TREAT AN ABDOMINAL AORTIC ANEURYSM, DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). AFTER THE 4 FR DIAGNOSTIC CATHETER AND A CARRY LEÓN MICROCATHETER (UTM) APPROACHED THE INTERNAL ILIAC ARTERY, EMBOLIZATION WAS INITIATED. THE FIRST COIL USED WAS A 20MM X 60CM DELTAFILL 18 (DLF182060 / 0932403S), BUT THE SHEATH SPLIT AT APPROXIMATELY 20-30CM FROM THE TIP DURING THE COIL INSERTION, CAUSING THE COIL TO PROTRUDE MAKING INSERTION DIFFICULT. CONSEQUENTLY, THE COIL WAS REMOVED. IT WAS REPLACED WITH ANOTHER 20MM X 60CM DELTAFILL 18 (DLF182060 / 0932403S). AFTER TWO ADDITIONAL COILS WERE PLACED, THE 20MM X 60CM DELTAFILL 18 (DLF182060 / 0932403S) WAS USED AS THE SECOND COIL. IT WAS REPORTED THAT WHEN THE 20MM X 60CM DELTAFILL 18 WAS INSERTED INTO THE MICROCATHETER, THE COIL BECAME ¿TRAPPED AT THE HUB¿ AND COULD NOT ADVANCE. UPON WITHDRAWING THE COIL FROM THE PATIENT¿S ANATOMY, THE COIL AND THE DELIVERY WIRE WERE OBSERVED TO BE DEFORMED. IT WAS THEN REPLACED WITH ANOTHER 20MM X 60CM DELTAFILL 18 (DLF182060 / 0932403S). THREE (3)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598157 ↗
• MalfunctionNov 13, 2025Separation Failure; Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PROCEDURE WAS A COIL EMBOLIZATION OF INFERIOR MESENTERIC ARTERY AND LUMBAR ARTERY. THE EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY AND LUMBAR ARTERY WAS PERFORMED WITH THE SYSTEM CONSISTING OF A 4FR ANGIOGRAPHIC CATHETER AND COILING SUPPORT (MEDICOS HIRATA). DURING EMBOLIZATION OF THE LUMBAR ARTERY, ATTEMPTED TO PLACE THE DELTAFILL18 10MM X 40CM COIL (DLF181040, 2232527S). THE POWER INDICATOR LIT BUT COULD NOT DETACH THE COIL. THE DELTAFILL18 COIL WAS RETRIEVED AND REPLACED WITH A COIL OF THE SAME SPECIFICATION, WHICH WAS PLACED WITHOUT PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542915 ↗
• MalfunctionNov 12, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL ILIAC ARTERY TO TREAT AN ABDOMINAL AORTIC ANEURYSM, DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). AFTER THE ANGIOGRAPHY CATHETER AND COILING SUPPORT CATHETER (MEDICOS HIRATA) APPROACHED THE INTERNAL ILIAC ARTERY, A MICRUSFRAME COIL WAS PLACED AS THE FIRST COIL AND A 20MM X 60CM DELTAFILL 18 (DLF182060) WAS PLACED INSIDE. THE 24MM X 60CM DELTAFILL 18 (DLF182460 / 1712508S) WAS THE THIRD COIL USED. AN ATTEMPT WAS MADE TO DEPLOY THE COIL, BUT ¿IT COULD NOT BE ENERGIZED AND COULD NOT BE DETACHED.¿ IT WAS THEN REPORTED THAT ANOTHER COIL HAD BEEN SUCCESSFULLY DETACHED, THE PHYSICIAN DETERMINED THAT IT WAS THE THIRD COIL THAT HAD THE PROBLEM AND REMOVED IT FROM THE PATIENT¿S BODY. THE 24MM X 60CM DELTAFILL 18 (DLF182460) WAS REPLACED WITH ANOTHER COIL OF THE SAME SPECIFICATION, AND IT WAS IMPLANTED WITHOUT ANY ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. ON 06-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION CONFIRMED THAT THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS STILL ATTACHED TO THE DELIVERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534263 ↗

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