DELTAMAXX CERECYTERecalls & reported problems across all models

We found 13 models of DELTAMAXX CERECYTE by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2016 and Jan 28, 2022 — classified as 11 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (19 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 DELTAMAXX CERECYTE problems

DELTAMAXX CERECYTE models

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

• DELTAMAXX CERECYTE CDX180312-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  12 reports
• DELTAMAXX CERECYTE CDX180835-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• DELTAMAXX CERECYTE CDX180415-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• DELTAMAXX CERECYTE CDX180520-30

  Device, Vascular, for Promoting Embolization
  6 reports
• DELTAMAXX CERECYTE CDX180625-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• DELTAMAXX CERECYTE CDX181650-30

  Device, Vascular, for Promoting Embolization
  4 reports
• DELTAMAXX CERECYTE CDX182460-30

  Device, Vascular, for Promoting Embolization
  3 reports
• DELTAMAXX CERECYTE CDX181040-30

  Device, Vascular, for Promoting Embolization
  2 reports
• DELTAMAXX CERECYTE CDX180733-30

  Device, Vascular, for Promoting Embolization
  1 report
• DELTAMAXX CERECYTE CDX180935-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAMAXX CERECYTE CDX181445-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAMAXX CERECYTE CDX181855-30

  Device, Vascular, for Promoting Embolization
  1 report
• DELTAMAXX CERECYTE CDX182060-30

  Device, Vascular, for Promoting Embolization
  1 report

Recent DELTAMAXX CERECYTE adverse event reports

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

• InjuryJan 28, 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, A (B)(6) YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE (CAD), DYSLIPIDEMIA, RENAL INSUFFICIENCY, AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 63MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED A TYPE II ENDOLEAK OF THE LUMBAR ARTERY 110 DAYS FOLLOWING THE PROCEDURE. ENDOVASCULAR REINTERVENTION WAS PERFORMED AS TREATMENT. THE PATIENT THEN UNDERWENT ENDOVASCULAR REINTERVENTION OF A TYPE IB ENDOLEAK 113 DAYS POST-PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA. THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 1,864 DAYS PRIOR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. ONE (1) CERENOVUS COIL, A 3MM X 12CM DELTAMAXX COILS (CDX18031230 / UNKNOWN LOT NUMBER) WAS IMPLANTED AT THE LUMBAR ARTERY. COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS.

  Patient problems: Aneurysm

  MAUDE report 13388938 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE AAA STUDY, A (B)(6) MALE PATIENT WITH A PAST MEDICAL HISTORY OF DYSLIPIDEMIA AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 54MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED TYPE II ENDOLEAK 221 DAYS AFTER THE PROCEDURE REQUIRING REINTERVENTION. THE PATIENT ALSO HAD A TYPE II ENDOLEAK OF A PREVIOUSLY UNIDENTIFIED VESSEL 161 DAYS POST-PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA; THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 1,993 DAYS PRIOR TO THIS PROCEDURE. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. TWO (2) 3MM X 12CM DELTAMAXX COILS (CDX18031230 /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 13388733 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE AAA STUDY, A (B)(6) MALE PATIENT WITH A PAST MEDICAL HISTORY OF DYSLIPIDEMIA AND SMOKING (PREVIOUS) UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 54MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED TYPE II ENDOLEAK 221 DAYS AFTER THE PROCEDURE REQUIRING REINTERVENTION. THE PATIENT ALSO HAD A TYPE II ENDOLEAK OF A PREVIOUSLY UNIDENTIFIED VESSEL 161 DAYS POST-PROCEDURE. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA; THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 1,993 DAYS PRIOR TO THIS PROCEDURE. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. TWO (2) 3MM X 12CM DELTAMAXX COILS CDX18031230 / 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 13388721 ↗
• 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) FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION AND DYSLIPIDEMIA UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 77MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED A TYPE II ENDOLEAK 178 DAYS FOLLOWING THE PROCEDURE. OPEN REINTERVENTION WAS PERFORMED AS TREATMENT. IT IS NOT KNOWN WHETHER THE TYPE II ENDOLEAK WAS ASSOCIATED WITH THE TARGET VESSEL. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA. THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 402 DAYS PRIOR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. TWO (2) 3MM X 12CM DELTAMAXX COILS (CDX18031230 /UNKNOWN LOT NUMBER) WERE IMPLANTED AT THE LUMBAR ARTERY. COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS.

  Patient problems: Aneurysm

  MAUDE report 13335221 ↗
• 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) FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION AND DYSLIPIDEMIA UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF A 77MM INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE AND EXPERIENCED A TYPE II ENDOLEAK 178 DAYS FOLLOWING THE PROCEDURE. OPEN REINTERVENTION WAS PERFORMED AS TREATMENT. IT IS NOT KNOWN WHETHER THE TYPE II ENDOLEAK WAS ASSOCIATED WITH THE TARGET VESSEL. THE STUDY PROCEDURE WAS REINTERVENTION OF AAA. THE INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) WAS PERFORMED 402 DAYS PRIOR. THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. TWO (2) 3MM X 12CM DELTAMAXX COILS (CDX18031230 / UNKNOWN LOT NUMBER) WERE IMPLANTED AT THE LUMBAR ARTERY. COIL EMBOLIZATION WAS CONSIDERED SUCCESSFUL. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS.

  Patient problems: Aneurysm

  MAUDE report 13335219 ↗
• InjuryDec 23, 2021Adverse 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) FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, DIABETES, CEREBROVASCULAR DISEASE, AND DYSLIPIDEMIA UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 46MM ABDOMINAL AORTIC ANEURYSM (AAA) AND EXPERIENCED TYPE II TARGET VESSEL ENDOLEAKS AT DAYS 81 AND 179. THE PROCEDURE WAS AN INITIAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. STENT GRAFT USED WAS A GORE EXCLUDER LEG. A TOTAL OF TWO SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE INFERIOR MESENTERIC ARTERY (IMA): ONE 4MM X 15CM DELTAMAXX (CDX18041530 / LOT# UNKNOWN) AND ONE 5MM X 20CM DELTAMAXX (CDX18052030 / LOT# UNKNOWN). FLUOROSCOPY TIME WAS 157 MINUTES. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED TEN DAYS.

  Patient problems: Aneurysm

  MAUDE report 13080216 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED VIA THE AAA STUDY, A (B)(6) FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF HYPERTENSION, DIABETES, CEREBROVASCULAR DISEASE, AND DYSLIPIDEMIA UNDERWENT ENDOVASCULAR COIL EMBOLIZATION OF AN INFRARENAL 46MM ABDOMINAL AORTIC ANEURYSM (AAA) AND EXPERIENCED TYPE II TARGET VESSEL ENDOLEAKS AT DAYS 81 AND 179. THE PROCEDURE WAS AN INITIAL ABDOMINAL ENDOVASCULAR ANEURYSM REPAIR (EVAR). THE ETIOLOGY OF THE AAA WAS ATHEROSCLEROSIS. STENT GRAFT USED WAS A GORE EXCLUDER LEG. A TOTAL OF TWO SPECTRA (CERENOVUS) COILS WERE IMPLANTED AT THE INFERIOR MESENTERIC ARTERY (IMA): ONE 4MM X 15CM DELTAMAXX (CDX18041530 / LOT# UNKNOWN) AND ONE 5MM X 20CM DELTAMAXX (CDX18052030 / LOT# UNKNOWN). FLUOROSCOPY TIME WAS 157 MINUTES. THE COIL EMBOLIZATION WAS DEEMED SUCCESSFUL. THE PATIENT WAS HOSPITALIZED TEN DAYS.

  Patient problems: Aneurysm

  MAUDE report 13080211 ↗
• MalfunctionDec 28, 2020Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 24MM X 60CM DELTAMAXX CERECYTE® COIL (CDX18246030 / C38840) WAS THE FIRST COIL CHOSEN FOR THE PROCEDURE. THE PHYSICIAN DECIDED TO RETRACT THE COIL FOR REDEPLOYMENT, (THE SECOND ATTEMPT TO BETTER POSITION THE COIL). DURING THE RESHEATHING, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 24MM X 60CM DELTAMAXX CERECYTE® COIL AS REPLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED STRETCHED AND KINKED. BASED ON THE PRODUCT ANALYSIS 12/28/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11083620 ↗
• MalfunctionAug 14, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 8X35 DELTAMAXX CERECYTE 18SYS (CDX18083530, S13453) WAS BEING USED FOR FILLING, HOWEVER, THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RESHEATHING THE COIL, THE INTRODUCER WAS DEFECTED NOT TO BE UNZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893077 ↗
• MalfunctionApr 3, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN USED TWO OF THE DELTAMAXX CERECYTE 18SYS 16 X 50 COILS (CDX1815030), THE FIRST COIL (CDX1815030 / C29347) FAILED TO DETACH AS EXPECTED DESPITE THE USE OF TWO DIFFERENT DETACHMENT SYSTEMS. THE COIL WAS RETRIEVED AND REMOVED FROM THE PATIENT. THE SECOND COIL WAS USED AND IT DETACHED AS EXPECTED USING ONE OF THE DETACHMENT SYSTEMS. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION, NO SIGNIFICANT DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393479 ↗
• MalfunctionNov 17, 2017Kinked; Kinked

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT, DURING A PROCEDURE, FAILURE TO RE-SHEATH THE COIL WAS EXPERIENCED WITH A DELTAMAXX COIL (CDX18073330/C39304) AND A KINK WAS FOUND ON THE TIP OF AN ENVOY GUIDE CATHETER (67125805D/E11270) UPON OPENING THE BOX. THE PHYSICIAN USED ANOTHER OF THE SAME SIZE PRODUCTS TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7040810 ↗
• MalfunctionSep 27, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE COIL INTRODUCER OF A DELTAMAXX COIL (CDX18031230/S11045) GOT DAMAGED AND DURING PRODUCT ANALYSIS, IT WAS CONFIRMED THAT THE COIL WAS STRETCHED. THE PROCEDURE WAS PRE-SG TYPE II ENDOLOEAK PROPHYLAXIS COIL EMBOLIZATION OF AN ANEURYSM AT THE INFERIOR MESENTERIC ARTERY AND THE LUMBAR ARTERY. THE PATIENT WAS A MALE WHOSE VESSEL WAS MILDLY TORTUROUS AND NOT CALCIFIED. THE TARGET BLOOD VESSEL WAS ONE LOWER MESENTERIC ARTERY AND TWO LUMBAR ARTERIES. A PUNCTURE WAS MADE IN THE RIGHT FEMORAL ARTERY AND A GUIDING CATHETER, A GUIDEWIRE AND MICRO CATHETER WERE INSERTED. CONTRAST WAS PERFORMED WITH THE GUIDING CATHETER AND COIL EMBOLIZATION WAS STARTED AT THE LOWER MESENTERIC ARTERY. THE DELTAMAXX (COMPLAINT PRODUCT) WAS SELECTED AS THE 1ST COIL AND IT WAS PREPARED ACCORDING TO IFU. THE COIL WAS INSERTED BUT IT WAS UNDER SIZED FOR THE VASCULAR DIAMETER. THE PHYSICIAN TRIED TO RE-SHEATH THE COIL BUT ITS INTRODUCER GOT DAMAGED AND THE COIL COULD NOT BE RE-SHEATHED. THE COIL WAS REMOVED FROM THE PATIENT¿S BODY AND OTHER COILS (DELTAMAXX5MMX20CM/ DELTAMAXX4MMX15CM) WERE PLACED WITHOUT ANY PROBLEM. REPORTEDLY THERE WERE NO ISSUES WHEN THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6899412 ↗
• MalfunctionSep 4, 2017Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE COIL EMBOLIZATION, THE DELTAMAXX COIL (CDX18031230/ S10390) COULD NOT BE ADVANCED VIA THE UNSPECIFIED MICROCATHETER, AND DURING PRODUCT ANALYSIS, IT WAS FOUND THAT THE COIL HAD PROTRUDED THROUGH THE INTRODUCER AND WAS STRETCHED. THEY WITHDREW THE COIL AND USED A NEW COIL TO COMPLETE THE PROCEDURE. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THE MICROCATHETER AND DELTAMAXX DID NOT APPEAR DAMAGED DURING THE PROCEDURE. THE PRODUCTS WERE PREPPED AND USED AS PER THE IFU. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6840949 ↗
• MalfunctionJul 28, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A SUBCLAVIAN ARTERY ANEURYSM FOR TYPE 1A ENDOLEAK, A DELTAMAXX COIL (CDX18165030/ S00037) FAILED TO DETACH USING AN ENPOWER CONTROL CABLE (ECB00018200/ S13060). A 5FR MSKIT WAS INSERTED INTO THE VESSEL AND IT WAS TAKEN TO THE STENT GRAFT AT DISTAL END. FROM THAT ROUTE, THE MICROCATHETER WAS INSERTED INTO THE END LEAK PORTION THEN THE EMBOLIZATION WAS STARTED. AFTER 10 COILS (DELTAMAXX) WERE PLACED IN THE LESION, THE COMPLAINT DELTAMAXX WAS OPENED. ALL 10 COILS HAD DETACHED WITH THE SAME ENPOWER CONTROL CABLE. AFTER PRE-DEPLOYMENT ELECTRICAL CHECK, THE MICROCATHETER WAS INSERTED TOWARD THE DETACHMENT POINT. THE COMPLAINT COIL WAS CONNECTED TO THE COMPLAINT CABLE FOR DETACHMENT, BUT THE POWER LAMP DID NOT ILLUMINATE. THE DELIVERY WIRE WAS MOVED A LITTLE BACK AND FORTH, THEN THE POWER LAMP ILLUMINATED. THEN THE PHYSICIAN PRESSED THE DETACHMENT BUTTON, BUT IT COULD NOT BE DETACHED. HE MOVED THE DELIVERY COIL A LITTLE REPEATEDLY, BUT THE ISSUE CONTINUED. THEREFORE, THE ENPOWER CONTROL CABLE WAS REPLACED, BUT THE LAMP WAS ILLUMINATED INTERMITTENTLY. ENPOWER CONTROL BOX WAS REPLACED, BUT THE ISSUE CONTINUED. FINALLY, TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6749818 ↗
• MalfunctionJul 18, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE RESISTANCE WAS EXPERIENCED WHEN USING A DELTAMAXX COIL (CDX18083530/S10381) WHICH HAD ALSO UNRAVELED. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM AT THE ABDOMINAL STENT GRAFT INTERPOLATION AT THE RIGHT INTERNAL ILIAC ARTERY. THE PATIENT WAS (B)(6) MALE WHOSE VESSEL WAS MILDLY TORTUROUS AND NOT CALCIFIED. THE DELTAMAXX COIL (COMPLAINT PRODUCT) WAS INSERTED INTO THE MICRO CATHETER HOWEVER RESISTANCE WAS FELT. THE COIL WAS REMOVED FROM THE PATIENT AND WAS FOUND TO BE UNRAVELED. THE COIL WAS REPLACED WITH ANOTHER ONE (DIFFERENT LOT#). THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL BE RETURNED FOR I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6723313 ↗

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