CERECYTE PRESIDIORecalls & reported problems across all models

We found 16 models of CERECYTE PRESIDIO by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 88 adverse event reports in the FDA's MAUDE database, received between Sep 7, 2016 and Jan 30, 2024 — classified as 1 death, 4 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Stretched” (30 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 CERECYTE PRESIDIO problems

CERECYTE PRESIDIO models

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

• CERECYTE PRESIDIO PC4100517-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  17 reports
• CERECYTE PRESIDIO PC4100626-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 death16 reports
• CERECYTE PRESIDIO PC4100412-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  12 reports
• CERECYTE PRESIDIO PC4100730-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  9 reports
• CERECYTE PRESIDIO PC4181034-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• CERECYTE PRESIDIO PC4181240-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• CERECYTE PRESIDIO PC4181137-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• CERECYTE PRESIDIO PC4181647-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  4 reports
• CERECYTE PRESIDIO PC4181846-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• CERECYTE PRESIDIO PC4180933-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• CERECYTE PRESIDIO PC4181447-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• CERECYTE PRESIDIO PC4181550-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• CERECYTE PRESIDIO PC4182050-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• CERECYTE PRESIDIO PC4100829-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• CERECYTE PRESIDIO PC4180830-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• CERECYTE PRESIDIO PC4181750-30

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent CERECYTE PRESIDIO adverse event reports

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

• MalfunctionJan 30, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING THE PROCEDURE, THE PHYSICIAN FILLED THE ANEURYSM WITH A PRESIDIO 10 CERE 5MMX17CM COIL ((B)(6)). IT WAS FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610194 ↗
• MalfunctionJan 18, 2024Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR EMBOLIZATION PROCEDURE, A 5MM X 17CM PRESIDIO 10 CERECYTE COIL ((B)(4) / 30429071) FILLED IN THE ANEURYSM AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 18-JAN-2024, PER THE CERENOVUS SALES REPRESENTATIVE, NO ADDITIONAL INFORMATION CAN BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18537234 ↗
• MalfunctionJan 17, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS WERE FOUND UNRAVELED/STRETCHED, A PRESIDIO 10 CERE 6MMX26CM (PC (B)(4) AND A MSPHERE 10 PLAT 4MMX7.5CM SPH (B)(4). A PRESIDIO 10 CERE 6MMX26CM COIL (PC (B)(4) FAILED TO DETACH. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525829 ↗
• MalfunctionJan 17, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, TWO COILS WERE FOUND UNRAVELED/STRETCHED, A PRESIDIO 10 CERE 6MMX26CM (B)(4) AND A MSPHERE 10 PLAT 4MMX7.5CM (SPH10040020, 30443972). A PRESIDIO 10 CERE 6MMX26CM COIL (B)(4)) FAILED TO DETACH. NEW COILS WERE SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525826 ↗
• MalfunctionDec 28, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED INTERNAL CAROTID ARTERY (ICA) ANEURYSM EMBOLIZATION PROCEDURE, WITH THE (B)(6) FEMALE PATIENT UNDER GENERAL ANESTHESIA, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE COMPLAINT COIL, A 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC410051730 / K10429) IN THE MICROCATHETER, BUT IT THE COIL BECAME IMPEDED IN THE HUB SECTION OF THE MICROCATHETER (UNSPECIFIED BRAND). IT WAS REPORTED THAT FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AND THE COMPLAINT DEVICE WAS NOT SUBJECTED TO EXCESSIVE FORCE. THE PHYSICIAN RETRACTED THE COIL; IT WAS NOT USED IN THE PATIENT AND IT DID NOT GO THROUGH THE MICROCATHETER. A NEW COIL WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT. THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. DURING THE MICROSCOPIC INSPECTION OF THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL, THE EMBOLIC COIL WAS OBSERVED PROTRUDING FROM THE INTRODUCER AND IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 28 DEC 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13098589 ↗
• MalfunctionDec 6, 2021Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED EMBOLIZATION OF THE RIGHT INTERNAL CAROTID ARTERY, A COMPETITOR¿S MICROCATHETER (MC) WAS AT TARGET POSITION. A PRESIDIO 18 CERE 11MMX37CM COIL (PC418113730, 30399458) WAS DELIVERED TO THE MICROCATHETER AND PARTIALLY ARRIVED AT ANEURYSM. THE PHYSICIAN TRIED TO RETRACT THE COIL ¿A LITTLE¿ FOR ADJUSTING ITS POSITION, BUT FELT RESISTANCE. THE PHYSICIAN THEN DECIDED TO CONTINUE TO FILL THE ANEURYSM WITH THE REMAINING COIL, HOWEVER, THE COIL WAS DIFFICULT TO ADVANCE ANYMORE. AFTER SEVERAL ATTEMPTS, THE COIL ¿BROKE¿, ONE PART OF THE COIL THAT WAS ORIGINALLY INSIDE THE ANEURYSM REMAINED WHILE THE OTHER PART OF THE COIL OUTSIDE THE ANEURYSM WAS REMOVED. THE PHYSICIAN FILLED THE ANEURYSM WITH ANOTHER COIL AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORT. RETURNED MEDICAL IMAGING WAS REVIEWED BY A NEUROINTERVENTIONALIST. THE ASSESSMENT READS AS FOLLOWS: "THE EVENT DESCRIPTION PROVIDED BY THE PHYSICIAN INDICATES THE COIL DID NOT RESPOND WHICH CAN BE DUE TO PREMATURE DETACHMENT OR COIL STRETCHING. THE CONDITIONS OF PREMATURE DETACHMENT OR COIL STRETCHING ARE DESCRIBED IN LITERATURE AND KNOWN TO OCCUR IN = 2,5% OF CASES AND ARE N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932811 ↗
• MalfunctionOct 1, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION OF THE MIDDLE CEREBRAL ARTERY (M1 SEGMENT), A PRESIDIO 10 CERE 6MMX26CM COIL (PC410062630, 30399457) BECAME IMPEDED IN HUB PART WHEN IT TRYING TO ADVANCE WITHIN AN ECHELON10 MICROCATHETER (MC) DURING GENERAL ANESTHESIA SURGERY. THE PHYSICIAN RETRACTED IT (COIL WAS NOT USED IN PATIENT) AND REPLACED IT WITH A PRESIDIO 10 CERE 5MMX17CM COIL. THE NEW COIL DETACHED WITHOUT CHANGING THE MICROCATHETER. THERE WAS NOT PATIENT INJURED REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DAMAGE TO THE MC AT ANY TIME. THE COMPLAINT COIL DID NOT APPEAR DAMAGED AT ANY TIME. THERE WAS NOTHING OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561143 ↗
• MalfunctionSep 9, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED EMBOLIZATION PROCEDURE WITH THE TARGET LOCATION ON THE INTERNAL CAROTID ARTERY, IT WAS REPORTED THAT THE 6MM X 26CM PRESIDIO 10 CERECYTE COIL (PC410062630 / 30399457) WAS IMPEDED WHEN THE COIL WAS ADVANCING THROUGH THE CONCOMITANT ECHELON¿ 10 MICROCATHETER (MEDTRONIC). IT WAS REPORTED THAT THE COIL WAS SEVERAL CENTIMETERS AT THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN WITHDREW THE COIL; IT WAS STATED THAT THE COIL DID NOT DIRECTLY CONTACT THE PATIENT¿S BODY. THE PHYSICIAN SUCCESSFULLY REMOVED THE COMPLAINT COIL FROM THE PATIENT WITHOUT REMOVING THE MICROCATHETER; TARGET POSITION WAS NOT LOST. THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC410051730) WAS USED AS REPLACEMENT AND IT WAS SUCCESSFULLY DETACHED. THE PATIENT DID NOT SHOW ANY UNUSUAL SYMPTOMS AFTER THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE. ADDITIONAL INFORMATION INDICATED THAT THE MICROCATHETER WAS NOT DAMAGED DURING THE MANIPULATION OF THE DEVICE. THE COMPLAINT COIL DID NOT APPEAR DAMAGE. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451491 ↗
• MalfunctionJun 21, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE, THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC (B)(4) / LOT# UNKNOWN) FAILED TO DETACH. THE PHYSICIAN SWITCHED TO ANOTHER COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033392 ↗
• MalfunctionJun 8, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC410051730 / S15008) COULD NOT BE DETACHED WHEN IT WAS DELIVERED TO THE TARGET CEREBRAL POSITION. THE PHYSICIAN WITHDREW THE COIL ONLY (NOT MOVE THE MICROCATHETER) AND SWITCHED TO A NEW COIL (MEDTRONIC); THE REPLACEMENT COIL WAS REPORTED TO WORK SUCCESSFULLY. THEN THE PHYSICIAN THEN INSERTED THE 4.5MM X 22MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452200 / 6253757) AND DELIVERED IT TO THE TARGET POSITION VIA THE 150CM X 5CM PROWLER SELECT PLUS (606S255X / 30487605). WHEN THE STENT COMPONENT WAS HALF DEPLOYED, THE PHYSICIAN THOUGHT THE POSITION SHOULD BE ADJUSTED. HE PLANNED TO WITHDRAW THE STENT BACK INTO THE MICROCATHETER, BUT THE ATTEMPT WAS NOT SUCCESSFUL. THE PHYSICIAN WITHDREW THE STENT AND THE MICROCATHETER FROM THE PATIENT. OUTSIDE THE PATIENT¿S BODY, THE MICROCATHETER WAS OBSERVED BENT. THE PHYSICIAN SWITCHED TO A NEW STENT (MEDTRONIC) AND MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958012 ↗
• MalfunctionMay 18, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, PRESIDIO 18 CERE COIL 14MMX47CM (PC418144730, L11951) BECAME IMPEDED. IT COULDN'T ADVANCE WITHIN THE UNSPECIFIED MICRO CATHETER (MC). NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842108 ↗
• MalfunctionMay 10, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE, WHEN THE 6MM X 26CM PRESIDIO 10 CERECYTE COIL (PC410062630 / K10342) REACHED THE TARGET POSITION, IT COULD NOT BE DETACHED. THE PHYSICIAN REMOVED IT FROM THE PATIENT¿S BODY AND SWITCHED TO A NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11800981 ↗
• MalfunctionMar 9, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE, THE 9MM X 33CM PRESIDIO 18 CERECYTE COIL (PC418093330 / K10442) WAS DELIVERED TO THE TARGET POSITION BUT IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED. THE PHYSICIAN REMOVED THE COMPLAINT COIL FROM THE PATIENT AND SWITCHED TO ANOTHER COIL TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. A PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT FILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448748 ↗
• MalfunctionDec 29, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ANEURYSM COIL EMBOLIZATION PROCEDURE, THE INDICATOR LIGHT OF THE DETACHMENT CONTROL BOX DID NOT WORK AND COULD NOT DETACH THE 5MM X 17CM PRESIDIO 10 CERECYTE COIL (PC410051730 / K10430). THE DETACHMENT CONTROL BOX (DCB) WAS REPORTED TO HAVE FULL ELECTRICITY. THE COMPLAINT COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED. THE COIL WAS NOT IN STRETCHED CONDITION WHEN IT WAS REMOVED. THE PHYSICIAN SWITCHED TO A NEW 5MM X 17CM PRESIDIO 10 CERECYTE COIL TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL ENPOWER DCB AND ENPOWER CONTROL CABLE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED BEFORE THE ATTEMPT TO DETACH THE COMPLAINT COIL. THE FAULT LIGHT WAS NOT SEEN, AND THE SYSTEM READY LIGHT DID NOT ILLUMINATE. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT AND THE AUDIBLE SIGNAL BEEP WAS NOT HEARD. ALL CONNECTIONS FIT PROPERLY WITHOUT THE APPLICATION OF FORCE. THE EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT PROCEDURE DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089979 ↗
• MalfunctionDec 14, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION TO THE LEFT INTERNAL CAROTID ARTERY (ICA), A 4MMX11.5CM PRESIDIO 10 CERE COIL (PC410041230, 459685) WAS UNABLE TO BE RELEASED. THE PHYSICIAN SWITCHED TO ANOTHER NEW COIL TO COMPLETE THE PROCEDURE. THERE WAS NOT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED. THE SAME DETACHABLE CONTROL BOX (DCB) WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS AND THE SAME CABLE WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THERE WAS NO COIL STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. THERE WAS NO ADDITIONAL INTERVENTION NEEDED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS SIMPLY WITHDRAWN WITH THE PUSHER. IT WAS NOT NECESSARY TO REMOVE THE HEADWAY 17 MICROVENTION CATHETER. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WAS A 20-MINUTE PROCEDURAL DELAY DUE TO THE EVENT. THE CONCOMITANT DEVICES FUNCTION AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003190 ↗

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