CP StentRecalls & reported problems across all models

We found 16 models of CP Stent by B Braun Interventional Systems, Inc in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2016 and Jun 23, 2023 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. 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 CP Stent problems

CP Stent models

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

• CP Stent™ 614311

  Aortic stent
  6 reports
• CP Stent™ 614308

  Aortic stent
  3 reports
• CP Stent™ 614309

  Aortic stent
  3 reports
• CP Stent™ 614310

  Aortic stent
  3 reports
• CP Stent™ 614516

  Aortic stent
  2 reports
• CP Stent™ 614376

  Aortic stent
  2 reports
• CP Stent™ 614478

  Aortic stent
  1 report
• CP Stent™ 614497

  Aortic stent
  1 report
• CP Stent™ 614509

  Aortic stent
  1 report
• CP Stent™ 614307

  Aortic stent
  1 report
• CP Stent™ 614363

  Aortic stent
  1 report
• CP Stent™ 614367

  Aortic stent
  1 report
• CP Stent™ 614368

  Aortic stent
  1 report
• CP Stent™ 614371

  Aortic stent
  1 report
• CP Stent™ 614375

  Aortic stent
  1 report
• CP Stent™ 614380

  Aortic stent
  1 report

Recent CP Stent adverse event reports

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

• MalfunctionJun 23, 2023Difficult to Insert; Device Dislodged or Dislocated; Difficult to Insert; Device Dislodged or Dislocated

  AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - MOUNTED COVERED CP WOULD NOT GO THROUGH A 12 FR D'VILL INTRODUCER. IT GOT STUCK IN THE SHEATH AND CAME OFF THE SHAFT. DR. KANTER CUT THE D'VILL TO TRY TO SALVAGE THE CP BUT IT WAS TOO DAMAGED TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192311 ↗
• MalfunctionJul 27, 2022Device Handling Problem; Device Handling Problem

  AS PER THE INITIAL REPORT FROM THE FOREIGN DISTRIBUTOR / USER FACILITY - "ALL THE STENT THE OUTER COVER WAS FLOPPY AND EASILY PEELABLE. HENCE WE HAD DIFFICULTY AS THE OUTER COVER WOULD MOVE AND THE STENT WORKED AS BARE STENT. THE MOUNTED STENT TOO THE BALLOON WAS ALREADY CRIMPED IE LOOKED LIKE USED BALLON ON WHICH THIS STENT WAS MOUNTED WAS REUSED. DEFINITELY NOT A PREMOUNTED STENT." UNMOUNTED COVERED CP STENTS HAD COVERING ISSUES ACCORDING TO THIS USER FACILITY. WILL BE REPORTED WITH 1318694-2022-00008. BOTH DEVICES WERE USED ON THE SAME PATIENT DURING THE SAME PROCEDURE. A COVERED MOUNTED STENT WAS THEN USED WITH NO REPORTED ISSUES WITH THE COVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15110874 ↗
• MalfunctionJul 27, 2022Device Handling Problem; Device Handling Problem

  AS PER THE INITIAL REPORT FROM THE FOREIGN DISTRIBUTOR / USER FACILITY - "ALL THE STENT THE OUTER COVER WAS FLOPPY AND EASILY PEELABLE. HENCE WE HAD DIFFICULTY AS THE OUTER COVER WOULD MOVE AND THE STENT WORKED AS BARE STENT. THE MOUNTED STENT TOO THE BALLOON WAS ALREADY CRIMPED IE LOOKED LIKE USED BALLON ON WHICH THIS STENT WAS MOUNTED WAS REUSED. DEFINITELY NOT A PREMOUNTED STENT." (2) UNMOUNTED COVERED CP STENTS HAD COVERING ISSUES ACCORDING TO THIS USER FACILITY. WILL BE REPORTED WITH 1318694-2022-00009. BOTH DEVICES WERE USED ON THE SAME PATIENT DURING THE SAME PROCEDURE. A COVERED MOUNTED STENT WAS THEN USED WITH NO REPORTED ISSUES WITH THE COVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15110871 ↗
• MalfunctionMay 6, 2022Material Separation; No Apparent Adverse Event; Material Separation; No Apparent Adverse Event

  AS PER THE REPORT SENT IN FROM THE DISTRIBUTOR / USER FACILITY - WHILE PREPPING THE STENT, THE GORTEX COVER CAME OFF OF THE METAL STENT FRAME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14305162 ↗
• MalfunctionOct 7, 2021No Apparent Adverse Event; No Apparent Adverse Event

  AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - AFTER CRIMPING THE COVERED STENT ON A 18MM OD BIB BALLOON - PRIOR TO ADVANCING IN 22MM GORE DRYSEAL SHEATH, THE COVERING WAS NOTED TO BE COMPLETELY OFF THE STENT. IT HAD BEEN SOAKING IN NS WITH HEPARIN SOLUTION 15 MINUTES PRIOR TO CRIMPING. INDICATION THE PHYSICIAN WAS USING THE STENT: SINUS VENOSUS ASD CLOSING. THERE WAS NO DIFFICULTY MOUNTING THE STENT. PROCESS FOR CRIMPING: SQUEEZED STENT. THE RING MANDRIL WAS NOT USED DURING THE CRIMPING PROCESS. THE STENT DID NOT SLIP. COVERING CAME OFF PRIOR TO INTRODUCTION INTO SHEATH. THE BLUE INTRODUCER TOOL WAS NOT USED. THE CATHETER SHAFT WAS NOT KINKED. ANOTHER COVERED CP STENT WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591612 ↗
• MalfunctionJul 2, 2021No Apparent Adverse Event; No Apparent Adverse Event

  AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR: PHYSICIAN WAS PREPPING AND THE STENT COVERING CAME OFF OF THE STENT, THE COVERING PEELED OFF. PHYSICIAN USED ANOTHER CP STENT THE EXACT SAME SIZE AND IT WORKED PERFECTLY. PHYSICIAN STATED THAT THIS HAS NEVER HAPPENED BEFORE. THE PRODUCT IS SAVED IN THE TUBE. THE SIZE OF THE BALLOON THE STENT WAS MOUNTED ON: BIB 16X3. PHYSICIAN BARELY BEGAN TO CRIMP AND THE COVERING CAME OFF OF THE STENT. THE RING MANDRIL WAS USED DURING THE CRIMPING PROCESS. THE COVERING CAME OFF BEFORE IT COULD BE USED. PHYSICIAN IS A LONG TIME CP STENT CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 12108329 ↗
• MalfunctionMar 11, 2021Improper or Incorrect Procedure or Method; Malposition of Device; Difficult to Advance; Material Split, Cut or Torn

  AS PER THE REPORT FROM THE DISTRIBUTOR / USER FACILITY - 14 FR D'VILL SHEATH IN RVOT, LUNDERQUIST WIRE, DIFFICULTY PASSING THE BALLOON STENT COMBO THOUGH THE CHECK FLOW VALVE, WITHOUT PROTECTOR. BEFORE THE STENT BALLOON COMBO EXITED THE DISTAL END OF THE SHEATH, A MAL-POSITION OF THE STENT ON THE BALLOON WAS NOTED. THE STENT BALLOON COMBO WAS REMOVED FROM THE SHEATH UNEVENTFULLY, ALTHOUGH A SLIGHT DAMAGE GORETEX ON THE DISTAL END OF THE STENT WAS NOTED. ON THE BACK TABLE THE BALLOON USED TO EXPAND THE STENT RESULTED IN FURTHER TEAR OF GORETEX WITH ONLY ABOUT 1/3 OF THE STENT COVERED AFTER EXPANSION. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR WAS CONDUIT REHABILITATION PRIOR TO TPVR. THE BLUE INTRODUCER TOOL PROVIDED BY NUMED WAS NOT USED. THERE WAS AN ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE. NEITHER BALLOON WAS INFLATED IN THE PATIENT, ON THE BACK TABLE THE INNER WAS INFLATED FIRST. THE CATHETER SHAFT WAS NOT KINKED.

  Patient problems: Insufficient Information

  MAUDE report 11466588 ↗
• MalfunctionNov 12, 2020No Apparent Adverse Event; Device Handling Problem; No Apparent Adverse Event; Device Handling Problem

  AS REPORTED TO NUMED BY THE DISTRIBUTOR / USER FACILITY - WHILE CRIMPING THE STENT ONTO A 24X4 BIB THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE COVERING WAS SLIDING OFF THE STENT. THE INDICATION THE PHYSICIAN AS USING THE PRODUCT FOR: INTIMAL TEAR IN RV-PA CONDUIT. THERE WAS NO DIFFICULTY MOUNTING THE STENT. CRIMPING WAS MANUAL, BY HAND. THE RING MANDRIL WAS NOT USED DURING THE CRIMPING PROCESS. THE STENT WAS NOT USED ON THE PATIENT. THE BLUE INTRODUCER TOOL PROVIDED BY NUMED WAS NOT USED. THEY DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE AT ANY TIME. CONTRAST MEDIA WAS USED DURING PREP. THE BALLOON WAS NOT INFLATED, NO INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10828360 ↗
• MalfunctionFeb 24, 2020Detachment of Device or Device Component

  AS REPORTED BY THE DISTRIBUTOR / USER FACILITY - THE SLEEVE JUST CAME OFF THE STENT. I INTRODUCED THE CP COVERED STENT THE WAY I ALWAYS INTRODUCE IT, BUT IT WAS SOMEWHAT DIFFICULT TO GET THROUGH THE 14FR D'VILL SHEATH. THE STENT WAS ON AN 18MM BIB AND IT SHOULD HAVE GONE WITHOUT A SNAG. WE REDID IT WITH A DIFFERENT CP STENT AND EVERYTHING WENT GREAT AND NO SNAGS, SO I DON'T KNOW IF THERE WAS SOMETHING WITH THE SLEEVE ITSELF BUT THE SLEEVE COMPLETELY CAME OFF. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR WAS COARCTATION OF THE AORTA. THERE WAS NO DIFFICULTY MOUNTING THE STENT. THE COVERING CAME COMPLETELY OFF WHEN BEING INTRODUCED INTO THE 14FR D'VILL. (B)(6) 2020 - IN AN EMAIL FROM THE ACCOUNT: ONLY SALINE WAS USED DURING THE PREP. PHYSICIAN HAND MOUNTED IN THE USUAL WAY AND USED THE ENCLOSED SLEEVE TO INTRODUCE THROUGH THE VALVE OF THE D'VILL SHEATH. INSTRUCTIONS FOR USE AND MOUNTING PROCEDURE WERE FOLLOWED. THE 14FR INTRODUCER INCLUDED IN THE PACKET WITH THE CP COVERED STENT WAS USED. WITH INTRODUCTION OF THE STENT/BALLOON COMPLEX PHYSICIAN FELT RESISTANCE GOING THROUGH THE D'VILL SHEATH. PHYSICIAN DID NOT FEEL COMFORTABLE PUSHING ANY FURTHER AND THEREFORE REMOVED THE C

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9744204 ↗
• MalfunctionJan 3, 2020Unraveled Material

  AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - THE STENT COVER MATERIAL STARTED TO UNRAVEL FROM THE STENT AS IT WAS BEING ADVANCED THROUGH THE STENT INSERTION/DELIVERY TUBE. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR: PULMONARY ARTERY STENTING FOR PULMONARY VALVE IMPLANT. THE STENT WAS MOUNTED ON A 14MM X 4MM BIB 614412 WITHOUT DIFFICULTY. THE STENT WAS HAND CRIMPED, THE RING MANDRIL WAS USED DURING CRIMPING. THE STENT DID NOT SLIP. THE COVERING MATERIAL UNRAVELED DURING THE STENT ADVANCEMENT THROUGH THE INSERTION TOOL DURING INSERTION PAST THE SHEATH VALVE. THE BLUE INTRODUCER TOOL THAT CAM IN THE PACKAGE WAS USED. THERE WAS NO ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE AT ANY TIME. INCIDENT OCCURRED PRIOR TO THE NEED FOR INFLATION. A B. BRAUN 14FR D'VILL INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NO EVENT INVOLVING THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9548230 ↗
• MalfunctionDec 3, 2019Material Fragmentation

  AS PER THE REPORT FROM THE DISTRIBUTOR / USER FACILITY - "WHEN TRYING TO DEPLOY, SOME OF THE OUTER COATING STARTED TO COME OFF. PHYSICIAN MANAGED TO REMOVE THE REST OF IT, AND KEEP THE STENT IN PLACE. IMPLANT WAS USED FOR PLACING, TO MAKE A STABLE LANDING ZONE FOR POSSIBLE TRANSCATHETER VALVE PLACEMENT. THE STENT DID NOT SLIP. THERE WAS NO DIFFICULTY WHILE INSERTING THE BIB/STENT INTO THE INTRODUCER. THE BLUE INTRODUCER TOOL PROVIDED BY NUMED WAS NOT USED. THEY DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE AT ANY TIME. CONTRAST WAS USED IN THE BALLOON TO VISUALIZE AND SALINE WAS USED TO WIPE THE EXCHANGE WIRE. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE INTRODUCER SHEATH USED WAS 18FR 85CM LENGTH. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT'S CONDITION POST PROCEDURE WAS GOOD." THE STENT WAS PLACED WITHOUT THE COVERING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9402043 ↗
• MalfunctionOct 7, 2019Detachment of Device or Device Component

  AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - COVERED MOUNTED CP STENT COVERING CAME OFF WHEN INSERTING INTO THE D'VILL SHEATH. IT NEVER MADE IT INTO PATIENT. UPDATE 9/10/2019 - IN AN EMAIL FROM THE ACCOUNT: THE D'VILL WAS 14FR X 85CM CATALOG # 612845 LOT #: DV-0145 ST-1203; GUIDEWIRE USED WAS A .035 X 260CM LUNDERQUIST WIRE MADE BY COOK MEDICAL; PHYSICIAN DID NOT USE THE BLUE INSERTION TOOL, BUT DID CUT OFF THE END OF A TERUMO SHEATH TO USE AS AN INSERTION TOOL, WHICH WAS NOT SAVED; PHYSICIAN DID MANUALLY CRIMP THE STENT OUT OF THE PACKAGE BEFORE INSERTING INTO THE SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9162941 ↗
• MalfunctionSep 4, 2019Detachment of Device or Device Component

  AS PER THE REPORT FROM THE HOSPITAL / DISTRIBUTOR - THE SLEEVE DETACHED AND BEGAN TO SLIP OFF THE STENT WHEN CRIMPING ONTO THE BIB. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR: COARCTATION OF THE AORTA. THE BALLOON THE STENT WAS BEING MOUNTED ON: BB033. THEY DID NOT COMPLETELY MOUNT THE STENT DUE TO THE SLEEVE SEPARATING FROM THE STENT. THEY PLACED ANOTHER CP STENT WITH SUCCESS. THE STANDARD PROCESS OF CRIMPING WAS USED. THE BLUE INTRODUCER TOOL PROVIDED BY NUMED WAS NOT USED. THEY DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE AT ANY TIME. SALINE WAS USED DURING PREP. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE CATHETER SHAFT WAS NOT KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8961013 ↗
• MalfunctionApr 25, 2019Detachment of Device or Device Component; Physical Resistance/Sticking

  AS REPORTED TO NUMED ON A REPORT FROM THE DISTRIBUTOR: "INADEQUATE COVER FIXATION TO STENT. THE CP STENT COVER GOT STUCK IN A COOK CHECKFLO 18FR INTRODUCER SHEATH WHILE ADVANCING THE STENT THROUGH THE SHEATH. THE PHYSICIAN SAW THE STENT VIA FLUOROSCOPY AND FELT RESISTANCE. THEY RETRACTED BACK THROUGH THE HEMOSTASIS VALVE AND THE COVER CAME OUT SEPARATELY FROM THE STENT. UMBILICAL TAPE WAS USED TO TRY TO RE-CRIMP THE STENT, HOWEVER IT DID NOT WORK. THE STENT WAS ADVANCED UNCOVERED INTO THE VALVE SUCCESSFULLY. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR: RVOT AND TRANSCATHETER VALVE IMPLANT. CRIMPING WAS INVOLVED ONLY AFTER THE COVER CAME OFF OF THE STENT AFTER INITIAL ADVANCEMENT INTO INTRODUCER. THE RING MANDRIL WAS NOT USED DURING THE CRIMPING PROCESS. THE STENT DID NOT SLIP. NEITHER SALINE NOR CONTRAST MEDIA WAS USED DURING PREP. THE INNER BALLOON WAS INFLATED BEFORE THE OUTER BALLOON. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT CONDITION POST PROCEDURE WAS GOOD, THE CASE WAS SUCCESSFUL". "IT IS UNCLEAR IF THE HEMOSTASIS TOOLS WERE USED".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8549187 ↗
• MalfunctionAug 31, 2018Detachment of Device or Device Component

  AS REPORTED BY BIS "TEFLON COVER DETACHED FROM THE STENT. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR: COARCTATION REPAIR. THE BALLOON THE STENT WAS MOUNTED ON: 12X4 BIB. THE CRIMPING PROCESS USED: CRIMPED USING UMBILICAL TAPE AND LIGHT FINGER PRESSURE. THE RING MANDRIL WAS USED DURING THE CRIMPING PROCESS. THE STENT DID NOT SLIP. THE COVERING BECAME DETACHED AS THE BIB/STENT WAS BEING ADVANCED INTO THE SHEATH USING THE LOADER PROVIDED WITH THE STENT. THERE WAS NO DIFFICULTY ENCOUNTERED WHILE INSERTING THE BIB/STENT INTO THE INTRODUCER. THE BLUE INTRODUCER TOOL PROVIDED BY NUMED WAS USED. ACCOUNT DID NOT ATTEMPT TO PULL THE STENT BACK THROUGH THE HEMOSTASIS VALVE. SALINE MEDIA WAS USED DURING PREP. THE BALLOON WAS NOT INFLATED. A 9F INTRODUCER SHEATH WAS USED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE CATHETER SHAFT WAS NOT KINKED. THE PATIENT CONDITION POST PROCEDURE WAS NORMAL". "THE 12F HEMOSTASIS TOOL WAS USED".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838037 ↗

Other B Braun Interventional Systems, Inc products

• Multi-Track2 models · 0 reports · 2 recalls
• CELSITE7 models · 17 reports · 1 recall
• BIB6 models · 5 reports · 1 recall
• VENA TECH2 models · 48 reports
• TYSHAK II12 models · 25 reports