Confida™ GWBC30 (UDI 00763000060886)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00763000060886), received between Jul 10, 2018 and Jul 18, 2025 — classified as 21 deaths, 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (9 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, FOLLOWING FULL DEPLOYMENT, A POST-IMPLANT BALLOON DILATION WAS PERFORMED USING A 22 MM BALLOON. UPON REMOVAL, THE BALLOON INTERACTED WITH THE MEDTRONIC GUIDEWIRE. THIS INTERACTION CAUSED THE VALVE TO DISLODGE FROM POSITION. SUBSEQUENTLY, A SECOND VALVE WAS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE POST-DILATION WAS PERFORMED DUE TO A PARAVALVULAR LEAK. THE PATIENT WAS RAPID PACED DURING THE POST-IMPLANT BALLOON DILATION. THE VALVE IMPLANT DEPTH WAS ORIGINALLY 4 MM, BUT IT DISLODGED IN THE AORTIC DIRECTION. THE SECOND VALVE WAS IMPLANTED AT A DEPTH OF 3 MM ON THE NON-CORONARY CUSP AND LEFT CORONARY CUSP.

  Patient problems: Foreign Body In Patient

  MAUDE report 22542863 ↗
• DeathMar 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT PER THE PHYSICIAN, NEITHER THE GUIDEWIRE, VALVE, NOR THE DELIVERY CATHETER SYSTEM CAUSED OR CONTRIBUTED TO THE ADVERSE EVENTS.

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 21709183 ↗
• MalfunctionFeb 7, 2024Peeled/Delaminated; Material Twisted/Bent; Peeled/Delaminated; Material Twisted/Bent

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE USE OF THIS CONFIDA GUIDEWIRE, THE WIRE WAS REPORTED TO HAVE BROKE. FURTHER DETAILS ON THE BROKEN WIRE WERE NOT PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18661031 ↗
• DeathOct 23, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN TIME DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, A LEFT VENTRICLE PERFORATION WAS REPORTED AND THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Perforation

  MAUDE report 17990358 ↗
• DeathOct 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE IMPLANT OF THE TRANSCATHETER BIOPROSTHETIC VALVE, THE TIP OF THE GUIDEWIRE WAS NOT MANIPULATED PRIOR TO USE. THE GUIDEWIRE WAS PLACED IN THE APEX OF THE LEFT VENTRICLE USING A PIGTAIL CATHETER. THE GUIDEWIRE POSITION WAS MONITORED THROUGHOUT THE PROCEDURE AND WAS NOT REPOSITIONED. THE GUIDEWIRE POSITION WAS VISUALLY MONITORED USING TWO PROJECTIONS. PER THE PHYSICIAN, THE CAUSE OF THE LEFT VENTRICLE PERFORATION WAS UNKNOWN AND UNKNOWN IF THE GUIDEWIRE CONTRIBUTED TO THE EVENT.

  Patient problems: Cardiac Tamponade; Perforation

  MAUDE report 17977549 ↗
• InjuryNov 11, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VIA DIRECT AORTIC APPROACH, USING AN 18MM NON-MEDTRONIC SHEATH AND THE MEDTRONIC GUIDEWIRE, BLEEDING IN THE HEART WAS NOTED AND A LEFT VENTRICLE PERFORATION WAS REPORTED. ATTEMPTS WERE MADE TO IMPLANT THE MEDTRONIC VALVE, BUT THE PROCEDURE WAS CONVERTED TO OPEN HEART SURGERY DUE TO THE PATIENT¿S INCREASED HEMODYNAMIC INSTABILITY. SUBSEQUENTLY, A NON-MEDTRONIC SURGICAL VALVE WAS IMPLANTED AND THE LEFT VENTRICLE WAS REPAIRED WITH SUTURES. ULTIMATELY, THE BLEEDING STOPPED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15785136 ↗
• InjuryJun 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A TEMPORARY PACEMAKER ELECTRODE WAS PLACED IN THE RIGHT VENTRICLE. A PRE-IMPLANT DILATION WAS PERFORMED. THE VALVE WAS SUCCESSFULLY IMPLANTED. ECHOCARDIOGRAM AND ANGIOGRAPHY DID NOT SHOW ANY REGURGITATION. IT WAS REPORTED THAT THE PATIENT REMAINED STABLE THROUGHOUT THE VALVE IMPLANT. AT THE CONCLUSION OF THE PROCEDURE, PERICARDIAL EFFUSION WAS EVIDENT ON ECHOCARDIOGRAM. DRAINAGE WAS PERFORMED. THE PATIENT LEFT THE OPERATING ROOM WITH A VACUUM DRAIN. IT WAS REPORTED THAT THE PATIENT WAS WELL. PER THE PHYSICIAN, IT IS NOT KNOW WHETHER THE PACEMAKER OR THE GUIDEWIRE WITHIN THE LEFT VENTRICLE HAD PERFORATED RESULTING IN THE CARDIAC TAMPONADE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Perforation; Pericardial Effusion

  MAUDE report 14625601 ↗
• DeathMay 25, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, AS THE DELIVERY CATHETER SYSTEM (DCS) WAS BEING ADVANCED, THE GUIDEWIRE CAUSED A LEFT VENTRICLE RUPTURE. TAMPONADE OCCURRED AS A RESULT AND DRAINAGE WAS PERFORMED. SUBSEQUENTLY, THE PATIENT DIED THE SAME DAY. PER THE PHYSICIAN THE CAUSE OF DEATH WAS THE LEFT VENTRICLE LACERATION AND TAMPONADE CAUSED BY THE GUIDEWIRE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Rupture

  MAUDE report 14496394 ↗
• DeathMar 10, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHILE ADVANCING THE DELIVERY CATHETER SYSTEM (DCS) TOWARDS THE ANNULUS, A DECREASE IN BLOOD PRESSURE WAS REPORTED. CARDIAC ARREST ENSUED. THE VALVE WAS DEPLOYED AND IMPLANTED. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE PATIENT DID NOT SURVIVE. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC TAMPONADE IN THE APEX OF THE LEFT VENTRICLE.

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

  MAUDE report 13721671 ↗
• DeathFeb 9, 2022Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, DURING THE FINAL ANGIOGRAPHIC IMAGE WITH CONTRAST, A LEFT VENTRICLE PERFORATION WAS IDENTIFIED. PER THE PHYSICIAN, THE CAUSE OF THE PERFORATION WAS THAT THE MEDTRONIC GUIDEWIRE WAS SUSPECTED TO HAVE BEEN UNINTENTIONALLY PUSHED TOO HARD INTO THE APEX, RESULTING IN THE PERFORATION. THE PHYSICIAN CONFIRMED THAT THE MEDTRONIC GUIDEWIRE WAS THE ONLY WIRE USED IN THE LEFT VENTRICLE POSITION. CARDIAC TAMPONADE DEVELOPED; A PERICARDIOCENTESIS WAS ATTEMPTED, BUT WAS UNSUCCESSFUL. THE PATIENT'S CONDITION CONTINUED TO DETERIORATE AND CARDIAC SURGERY COULD NOT BE PERFORMED. SUBSEQUENTLY, THE PATIENT DIED.

  Patient problems: Cardiac Tamponade; Perforation of Vessels

  MAUDE report 13500628 ↗
• DeathNov 19, 2021Failure to Advance; Positioning Problem; Patient Device Interaction Problem; Failure to Advance; Positioning Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, INTO A PATIENT WITH A HIGHLY CALCIFIED BICUSPID, A PRE-IMPLANT DILATATION WAS PERFORMED WITH A 20 MM BALLOON AND A NON-MEDTRONIC STIFF WIRE. THE DELIVERY CATHETER SYSTEM (DCS) WAS UNABLE TO ADVANCE ACROSS THE VALVE. THE DCS WAS STOPPED AT THE NON-CORONARY CUSP (NCC). ANOTHER PRE-IMPLANT DILATATION WAS PERFORMED WITH A 23 MM BALLOON AND AN ADDITIONAL WIRE. THE DCS WAS STILL UNABLE TO ADVANCE PAST THE NCC. MULTIPLES ATTEMPTS WERE MADE TO ADVANCE, INCLUDING THE USE OF A CONFIDA WIRE. THE ATTEMPTS TO CROSS CONTINUED FOR APPROXIMATELY AN HOUR. THE PATIENT'S BLOOD PRESSURE DROPPED. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION AND PUNCTURE OF THE PERICARDIUM. CARDIAC TAMPONADE ENSUED. THE PROCEDURE WAS CONVERTED TO A THORACOTOMY. A DISSECTION WAS OBSERVED, WITH THE ORIGIN AT THE AORTIC ARCH EXTENDING TO THE AORTIC VALVE. THE PATIENT ULTIMATELY DIED. THE CAUSE OF DEATH WAS NOT REPORTED.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion; Vascular Dissection

  MAUDE report 12846306 ↗
• DeathNov 17, 2021Device Dislodged or Dislocated; Patient Device Interaction Problem; Device Dislodged or Dislocated; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 29 MM TRANSCATHETER BIOPROSTHETIC VALVE INTO A PATIENT WITH A BICUSPID AORTIC VALVE (FUSED LEFT CORONARY CUSP (LCC) AND RIGHT CORONARY CUSP (RCC)) AND EXTREME CALCIFICATION IN THE RIGHT CORONARY SINUS, THREE PRE-IMPLANT BALLOON DILATIONS WERE PERFORMED USING A 23MM BALLOON. AFTER THE BALLOON DILATIONS, SEVERE AORTIC INSUFFICIENCY WAS NOTED. UPON PLACEMENT OF THE CONFIDA GUIDEWIRE INTO THE VENTRICLE, THE PATIENT DECOMPENSATED. LOW CARDIAC OUTPUT WAS REPORTED. VENTRICULAR FIBRILLATION (VFIB) AND HYPOTENSION OCCURRED. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS PROVIDED, AND AN ATTEMPT WAS MADE TO IMPLANT THE VALVE. ON THE FIRST ATTEMPT, THE VALVE WAS POSITIONED HIGH AND WAS RECAPTURED. THE VALVE WAS REPOSITIONED AND FULLY DEPLOYED AT A DEPTH OF 1MMM, WHICH WAS THE PLANNED IMPLANT DEPTH. THE PATIENT REMAINED IN VFIB WITH LOW SYSTOLIC AND DIASTOLIC PRESSURES. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND THE USE OF ECMO CONTINUED DUE TO CARDIAC ARREST. THE VALVE DISLODGED UP AS A RESULT OF RESUSCITATION MEASURES. IT WAS ALSO REPORTED THAT THE PATIENT HAD PREVIOUSLY CORONARY REVASCULARIZATION AND THE IMPLANT TEAM

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cardiac Arrest; Cardiovascular Dysfunction/Insufficiency; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension; Low Cardiac Output; Ventricular Fibrillation

  MAUDE report 12832542 ↗
• DeathAug 20, 2021Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE FOR A TRANSCATHETER BIOPROSTHETIC VALVE, A NON-MEDTRONIC STRAIGHT WIRE WAS INTRODUCED INTO THE LEFT VENTRICLE (LV). A NON-MEDTRONIC CATHETER WAS THEN USED. THE IMPLANT TEAM INTENDED TO EXCHANGE THE CATHETERS, HOWEVER IT WAS NOT POSSIBLE TO EXCHANGE THE CATHETER FOR A PIGTAIL CATHETER BECAUSE THE NATIVE AORTIC VALVE WAS UNABLE TO BE RE-CROSSED. THE NON-MEDTRONIC CATHETER WAS REINTRODUCED INTO THE LV AND THIS GUIDEWIRE WAS PLACED THROUGH THE CATHETER AND INTO THE LV. A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. THE VALVE WAS IMPLANTED. FOLLOWING THE VALVE IMPLANT, TACHYCARDIA AND HYPOTENSION WERE REPORTED. A LV PERFORATION WAS REPORTED. RESUSCITATION WAS PERFORMED, BUT WAS NOT SUCCESSFUL. SUBSEQUENTLY, THE PATIENT DIED.

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

  MAUDE report 12347664 ↗
• DeathDec 11, 2020Adverse 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, USING A MEDTRONIC GUIDEWIRE, THE VALVE WAS DEPLOYED WITHOUT ISSUE. HOWEVER, A LEFT VENTRICLE PERFORATION OCCURRED. IT WAS SUSPECTED THAT THE GUIDEWIRE CAUSED THE PERFORATION. AS A RESULT, THE PATIENT DIED DURING THE PROCEDURE. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Cardiac Perforation

  MAUDE report 10991712 ↗
• DeathNov 19, 2020Adverse 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, THIS GUIDEWIRE WAS MANIPULATED TO ADVANCE THE SYSTEM. THE GUIDEWIRE CAUSED A LEFT VENTRICLE PERFORATION AND PERICARDIAL EFFUSION. IT WAS REPORTED THAT A PRE-EXISTING PERICARDIAL EFFUSION WAS PRESENT. PERICARDIOCENTESIS WAS ATTEMPTED. CARDIOPULMONARY RESUSCITATION (CPR) COMPRESSIONS WERE PERFORMED AND MEDICATION WAS ADMINISTERED. IT WAS REPORTED THAT SURGERY WAS NOT AN OPTION FOR THE PATIENT AND THE PATIENT SUBSEQUENTLY EXPIRED. PER THE PHYSICIAN, WIRE MANIPULATION BY THE OPERATOR CAUSED THE PERFORATION.

  Patient problems: Perforation of Vessels; Pericardial Effusion

  MAUDE report 10868779 ↗
• DeathNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, A LEFT VENTRICLE PERFORATION OCCURRED WITH THIS GUIDEWIRE. THE PATIENT STABILIZED AND THE VALVE WAS IMPLANTED. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM, BUT EXPIRED. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS UNKNOWN. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: Cardiac Perforation; Death

  MAUDE report 10813815 ↗
• DeathAug 11, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A LEFT VENTRICLE RUPTURE OCCURRED FOLLOWING DEPLOYMENT OF THE VALVE WHEN THE PATIENT'S BLOOD PRESSURE DROPPED FROM 160 TO 40. THE RUPTURE WAS TREATED WITH AN OPEN SURGICAL REPAIR. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN LOST THE WIRE AND HAD TO RE-ENTER IT INTO THE VENTRICLE 3 - 4 TIMES. THE GUIDEWIRE WAS INTRODUCED THROUGH A CATHETER PER NORMAL PROTOCOL. THE GUIDEWIRE WAS NOT TORQUED OR TWISTED DURING THE PROCEDURE. THE TIP OF THE GUIDEWIRE WAS NOT MANIPULATED PRIOR TO USE. THE PATIENT HAD FRIABLE TISSUE, WHICH MAY HAVE CONTRIBUTED TO THE INJURY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Death; Low Blood Pressure/ Hypotension; Rupture; Stroke/CVA

  MAUDE report 10392347 ↗
• InjuryJul 14, 2020Adverse 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 INTO A PATIENT WITH A SMALL LEFT VENTRICLE, BEFORE THE VALVE WAS DELIVERED, THE GUIDEWIRE PERFORATED THE LEFT VENTRICLE. THERE WAS NO ISSUE WITH THE GUIDEWIRE REPORTED. OPEN SURGERY WAS PERFORMED TO REPAIR THE PERFORATION USING SUTURE. A SECOND VALVE WAS OPENED AND PREPPED AS THE REPAIR TO THE VENTRICLE TOOK OVER TWO HOURS. A TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED. THE GUIDEWIRE WAS DELIVERED VIA A PIGTAIL CATHETER. THERE WERE NO ABNORMALITIES NOTED WITH THE TECHNIQUE FOR USING THE GUIDEWIRE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Perforation

  MAUDE report 10270806 ↗
• InjuryFeb 26, 2020Adverse 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, INTO A PATIENT WITH A NATIVE BICUSPID VALVE, A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY WAS PERFORMED OVER THE CONFIDA GUIDEWIRE. ON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE WAS CONSTRAINED AND IN A HIGH POSITION. THE PATIENT'S BLOOD PRESSURE WAS LOW; THEREFORE, THE VALVE WAS RECAPTURED. THE PRESSURE REMAINED LOW. THE VALVE WAS RE-ADVANCED AND SUCCESSFULLY DEPLOYED IN AN ADEQUATE POSITION. THE PATIENT'S PRESSURES REMAINED LOW, AND AN EFFUSION WAS REPORTED VIA ECHOCARDIOGRAM. IMAGING OF THE LEFT VENTRICLE CONFIRMED A PERFORATION IN THE APEX OF THE LEFT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED. THE PROCEDURE WAS CONVERTED TO OPEN HEART SURGERY FOR REPAIR OF THE APEX. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 9757831 ↗
• DeathJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS 29MM TRANSCATHETER BIOPROSTHETIC VALVE, USING A 6 FR DILATOR WITH THIS GUIDEWIRE, THE BLOOD PRESSURES WERE LOW AND DID NOT IMPROVE. A CONTRAST INJECTION IN THE LEFT VENTRICLE SHOWED EXTRAVASATION FROM A PERFORATION AT THE APEX OF THE HEART. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS TRANSFERRED TO THE OPERATING SUITE TO REPAIR THE PERFORATION. ATTEMPTS TO SUTURE THE PERFORATION CAUSED MICRO TEARS DUE TO THE PATIENT¿S FRIABLE TISSUE. FOLLOWING THE ATTEMPT TO SURGICALLY REPAIR THE VENTRICLE, THE PATIENT DIED. PER THE PHYSICIAN, THE PERFORATION LIKELY OCCURRED DURING VALVE DEPLOYMENT WITH FORWARD PRESSURE ON THE CONFIDA GUIDEWIRE IN A VERY FRAGILE, EXTREMELY SMALL VENTRICLE WITH FRIABLE TISSUE DUE TO THE PATIENT'S MEDICAL HISTORY. IT WAS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

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

  MAUDE report 9611456 ↗
• DeathDec 20, 2019Adverse 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, AT 80% DEPLOYMENT, HYPOTENSION WAS NOTED. THE VALVE WAS DEPLOYED AND FUNCTIONING, HOWEVER THE BLOOD PRESSURE DID NOT RECOVER. ECHOCARDIOGRAM INDICATED A PERICARDIAL EFFUSION. THE EFFUSION WAS DRAINED AND ANTICOAGULATION WAS REVERSED. SUBSEQUENTLY, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN, HOWEVER IT WAS REPORTED THAT THERE WAS A POSSIBLE LEFT VENTRICULAR PERFORATION CAUSED BY THE GUIDEWIRE. AN AUTOPSY WAS NOT PERFORMED.

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

  MAUDE report 9504653 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AFTER REMOVAL OF THE GUIDEWIRE A DROP IN BLOOD PRESSURE WAS SEEN. A LEFT VENTRICLE PERFORATION WAS NOTED AND THE PATIENT WAS PUT ON BYPASS AND CONVERTED TO OPEN SURGICAL REPAIR. PER THE PHYSICIAN, THE CAUSE OF THE PERFORATION WAS THE WIRE, HOWEVER, THERE WAS NO MENTION OF USER ERROR AND THE PATIENT'S "FRIABLE TISSUE" WAS SUGGESTED AS A POTENTIAL FACTOR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 9202882 ↗
• InjuryOct 3, 2019Adverse 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 VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE ADVANCED ACROSS THE AORTIC ANNULUS. THE PATIENT BECAME HYPOTENSIVE. A TEMPORARY PACER WAS ATTEMPTED TO BE PLACE, BUT THERE WERE POSITIONING DIFFICULTIES. THE PHYSICIAN REMOVED THE EVOLUT SYSTEM AND EXCHANGED IT FOR A 16 FR SHEATH. IT WAS THOUGHT THAT THE GUIDEWIRE AND EVOLUT SYSTEM WERE CONTRIBUTING TO THE HYPOTENSION BY KEEPING THE NATIVE VALVE OPEN. THE PRESSURE DID NOT RECOVER. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. AN ANGIOGRAM REVEALED A PERFORATION IN THE APEX OF THE LEFT VENTRICLE. THE PHYSICIAN ATTEMPTED AN OPEN REPAIR BY PLACING PATCHES AT THE APEX. IT WAS REPORTED THAT THE TISSUE WAS FRIABLE BECAUSE IT WAS DIFFICULT FOR THE SURGEON TO PATCH. THE PATIENT WAS STABLE AT THE END OF THE REPAIR. NO VALVE WAS EVER IMPLANTED. PER THE PHYSICIAN, THE CAUSE OF THE PERFORATION WAS UNKNOWN. IT WAS SUGGESTED THAT THE STRAIGHT WIRE DURING CROSSING OF THE NATIVE VALVE, OR THE GUIDE WIRE DURING INSERTION OF THE EVOLUT SYSTEM MAY HAVE CAUSED THE PERFORATION. THE TIP OF THE GUIDEWIRE WAS NOT PRE-SHAPED PRIOR TO USE, IT WAS UNKNOWN WH

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

  MAUDE report 9152084 ↗
• InjurySep 11, 2019Adverse 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 VALVE WAS PREPPED AND LOADED SUCCESSFULLY. THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED VIA THE LEFT GROIN ACCESS USING A 16 FR INLINE SHEATH OVER THE GUIDEWIRE. THE VALVE WAS NAVIGATED UP THE AORTA AND OVER THE ARCH. THE VALVE WAS ABLE TO CROSS WITHOUT COMPLICATION. THE VALVE WAS SUCCESSFULLY DEPLOYED AND RELEASED AT A DEPTH OF 4 MILLIMETER (MM). THE PRESSURE DID NOT RECOVER POST DEPLOYMENT. AN ECHOCARDIOGRAM IDENTIFIED A PERICARDIAL EFFUSION. THE DELIVERY CATHETER SYSTEM (DCS) WAS REMOVED AND A PERICARDIAL WINDOW WAS PERFORMED. A LEFT VENTRICULAR APEX PERFORATION WAS IDENTIFIED DUE TO THE GUIDEWIRE. THE CHEST WAS OPENED. PERFUSION AND A PATCH WAS APPLIED TO THE LEFT VENTRICLE PERFORATION. IT WAS REPORTED THAT THE PATIENT HAD THICK MYOCARDIUM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 8996887 ↗
• DeathJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, ASSESSMENT OF THE ECHOCARDIOGRAM SHOWED THE LEFT VENTRICLE WAS LACERATED. THE LACERATION WAS REPORTED TO HAVE BEEN CAUSED BY A MEDTRONIC GUIDEWIRE. APPROXIMATELY FOURTEEN HOURS FOLLOWING VALVE IMPLANT, THE LEFT VENTRICLE RUPTURED. IT WAS REPORTED THAT NO MEDICAL INTERVENTION WAS PERFORMED TO ADDRESS THE LACERATION OR RUPTURED VENTRICLE. SUBSEQUENTLY, THE PATIENT DIED. AN AUTOPSY WAS PERFORMED; THE CAUSE OF DEATH WAS DUE TO THE RUPTURED LEFT VENTRICLE. IT WAS REPORTED THAT A 14FR INLINE SHEATH WAS USED AND THERE WAS NOTHING OF NOTE IN TERMS OF PATIENT ANATOMY THAT CONTRIBUTED TO THE INJURY.

  Patient problems: Death; Laceration(s); Rupture

  MAUDE report 8710412 ↗