Confida™ GWBC30 (UDI 00643169583733)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169583733), received between Jul 13, 2017 and Aug 1, 2018 — classified as 4 deaths, 5 injuries.

The most frequently reported specific device problem is “Bent” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2018Failure to Align; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE CONFIDA GUIDEWIRE WAS INTRODUCED INTO A CATHETER WHICH WAS POSITIONED IN THE VENTRICLE. IT WAS REPORTED THAT THE GUIDEWIRE PERFORATED THE LEFT VENTRICLE. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED AND THE PERFORATION WAS REPAIRED SURGICALLY. THE VALVE WAS UNABLE TO BE IMPLANTED. IT WAS REPORTED THAT THE GUIDEWIRE WAS NOT SHAPED IN ANY WAY PRIOR TO USE AND THAT IT WAS NOT TWISTED OR TORQUED DURING USE. RESISTANCE WAS EXPERIENCED DURING GUIDEWIRE USE. PER THE PHYSICIAN, THE WIRE WAS ADVANCED IN ORDER TO ALIGN THE VALVE WITH THE OUTFLOW TRACK, WHICH CAUSED THE PERFORATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Low Cardiac Output; Perforation

  MAUDE report 7738307 ↗
• InjuryJul 25, 2018Material Perforation; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THIS CONFIDA GUIDEWIRE PERFORATED THE LEFT VENTRICLE. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS INITIATED AND THE PERFORATION WAS REPAIRED SURGICALLY. THE VALVE WAS ABLE TO BE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest; Cardiac Perforation; Low Blood Pressure/ Hypotension; Low Cardiac Output; No Known Impact Or Consequence To Patient

  MAUDE report 7719784 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE GUIDEWIRE APPEARED TO HAVE A CONTINUOUS CURVE AT THE END OF THE WIRE AND LACERATED THE VENTRICLE DURING POST DILATION. A FULL STERNOTOMY WAS PERFORMED TO REPAIR THE VENTRICLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 7402801 ↗
• DeathMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, THE GUIDEWIRE MAY HAVE BEEN PUSHED WITH TOO MUCH FORCE DURING IMPLANTATION. THE MOVEMENT OF THE GUIDEWIRE AGAINST THE WALL OF THE VENTRICLE MADE A HOLE IN THE LEFT VENTRICLE, THAT CAUSED A TAMPONADE. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND THE PROCEDURE WAS CONVERTED TO OPEN HEART SURGERY. THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Death

  MAUDE report 7375125 ↗
• DeathDec 19, 2017Material Torqued; Material Torqued

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, INTO A HEAVILY CALCIFIED BICUSPID VALVE WITH CALCIFICATION EXTENDING INTO THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT), THE ANNULUS WAS PRE-DILATED WITH A 18MM BALLOON AND A 26MM VALVE WAS IMPLANTED. A POST IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED AND THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM INDICATED A PERICARDIAL EFFUSION AND CARDIAC TAMPONADE. A LEFT VENTRICLE PERFORATION CAUSED BY THE GUIDEWIRE OCCURRED. IT WAS REPORTED THAT THE GUIDEWIRE HAD NOT BEEN RESHAPED AND HAD BEEN INSPECTED FOR ANY ABNORMALITIES PRIOR TO INTRODUCTION INTO THE PATIENT. NO RESISTANCE HAD BEEN FELT DURING USE, HOWEVER IT HAD BEEN ¿TORQUED OR TWISTED¿ DUE TO DIFFICULT ANATOMY AND SMALL LEFT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED AND MEDICATIONS TO SUPPORT THE PATIENT¿S BLOOD PRESSURE WERE ADMINISTERED. AN ANNULAR RUPTURE CAUSED BY THE BALLOON AORTIC VALVULOPLASTY (BAV) WAS ALSO CONFIRMED. A LAPAROTOMY WAS PERFORMED DUE TO A DISTENDED ABDOMEN AND CONFIRMED A LIVER LACERATION DUE TO A DIAGNOSTIC CATHETER. A SURGICAL REPAIR OF BOTH THE LIVER AND ANNULUS WAS PERFORMED, HOWEVER THE PATIENT

  Patient problems: Cardiac Perforation; Death; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 7129812 ↗
• DeathOct 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, PRIOR TO DEPLOYMENT THE GUIDEWIRE WAS POSITIONED INTO THE LEFT VENTRICLE (LV) THROUGH A PIGTAIL CATHETER. THERE WAS REPORTED DIFFICULTY POSITIONING THE WIRE INTO THE APEX DUE TO A SMALL LV AND SIGMOID SEPTUM. THE GUIDEWIRE PERFORATED THE LV AND CAUSED CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED AND SUBSEQUENT OPEN SURGICAL REPAIR OF THE PERFORATION. THE PATIENT SUBSEQUENTLY EXPIRED THE FOLLOWING MORNING.

  Patient problems: Cardiac Tamponade; Death; Perforation

  MAUDE report 6914872 ↗
• InjuryAug 21, 2017Bent; Adverse Event Without Identified Device or Use Problem; Scratched Material; Bent; Adverse Event Without Identified Device or Use Problem; Scratched Material

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE THE GUIDEWIRE WAS IN THE LEFT VENTRICLE AND THE DELIVERY CATHETER SYSTEM (DCS) WAS AT THE LEVEL OF THE ANNULUS, THE PATIENT BECAME HYPOTENSIVE AND A CARDIAC TAMPONADE WAS NOTED. THE VENTRICLE WAS REPAIRED AND THE PROCEDURE WAS CONVERTED TO A DIRECT AORTIC APPROACH WITH THE USE OF CARDIOPULMONARY BYPASS. THE VALVE WAS SUCCESSFULLY IMPLANTED AND THE PATIENT WAS PLACED ON AN INTRA-AORTIC BALLOON PUMP FOR HEMODYNAMIC SUPPORT. IT WAS SUSPECTED THAT THE GUIDEWIRE OR THE NON MEDTRONIC TERUMO STRAIGHT TIP WIRE HAD CAUSED THE TRAUMA TO THE VENTRICLE. THE PATIENT STABILIZED AND THE IABP WAS REMOVED THE FOLLOWING DAY. IT WAS REPORTED THE GUIDEWIRE HAD BEEN INTRODUCED THROUGH A PIGTAIL CATHETER. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 6806798 ↗
• DeathAug 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, A LEFT VENTRICLE PERFORATION WAS NOTE D AT THE APEX DURING VALVE DEPLOYMENT. SINCE THE BLOOD PRESSURE DECREASED AND WAS NOT RECOVERING, THE VALVE WAS PULLED UP INTO THE ASCENDING AORTA TO STABILIZE THE PATIENT. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED AND ANESTHESIA SUPPORT WAS PROVIDED BUT THE PATIENT SUBSEQUENTLY EXPIRED DUE TO THE PERFORATION. PER THE PHYSICIAN, THE PERFORATION WAS CAUSED BY THE MEDTRONIC GUIDEWIRE. NO AUTOPSY WAS PERFORMED.

  Patient problems: Cardiac Perforation; Death; Low Blood Pressure/ Hypotension

  MAUDE report 6768076 ↗
• InjuryJul 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE GUIDEWIRE PERFORATED THE LEFT VENTRICLE DURING THE PRE-BALLOON AORTIC VALVULOPLASTY (BAV). THE PATIENT RECOVERED WITH CARDIOPULMONARY RESUSCITATION (CPR) AND A PERICARDIAL DRAIN WAS PERFORMED. THE VALVE WAS IMPLANTED SUCCESSFULLY AND A POST BAV WAS PERFORMED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Perforation; Left Ventricular Hypertrophy

  MAUDE report 6712087 ↗