SJM Regent™ AGFN-756 (REF 21AGFN-756)Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 05414734005975), received between Jul 4, 2018 and May 13, 2024 — classified as 3 deaths, 28 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (25 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6)2024, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. DURING PREPARATION, THE LEAFLET MOVING WAS TESTED USING SPECIALIZED INSTRUMENTS. DURING PROCEDURE, POOR ACTIVITY WAS NOTED WITH OPENING AND CLOSING OF THE LEAFLETS. ANEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN AND COMPLETED THE PROCEDURE WHILE PATIENT REMAINED ON THE BYPASS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19306173 ↗
• InjuryMay 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. THE VALVE WAS IMPLANTED. AFTER THE IMPLANTATION, IT WAS NOTED THAT THE MECHANICAL LOBE HAD A LIMITATIONS IN MOBILITY. THE CARDIOPULMONARY BYPASS PLACED BACK ON, THE VALVE WAS EXPLANTED AND A NEW 19MM JM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN AND COMPLETED THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, BUT IT DIDN'T LEAD TO ANY ADVERSE EVENTS. THE PATIENT WAS REPORTED DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240327 ↗
• MalfunctionApr 2, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR A PROCEDURE. THE VALVE WAS IMPLANTED. WHEN THE PHYSICIAN TRIED TO ROTATE THE VALVE, THE VALVE WAS NOT ABLE TO BE ROTATED, RESISTANCE WAS FELT. THE VALVE WAS REPLACED WITH NEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF VALVE. THE REPLACEMENT VALVE WAS SUCCESSFULLY IMPLANTED. THERE WAS NO DELAY AND NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020231 ↗
• MalfunctionApr 1, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  USER FACILITY MEDWATCH REPORT (B)(4) RECEIVED THAT STATES "AFTER SUTURING IN THE SIZE 21 ST. JUDE REGENT VALVE IN THE PATIENT, THE SURGEON ATTEMPTED TO TURN THE MECHANICAL VALVE WITH DIFFICULTY. THE SURGEON ATTEMPTED AGAIN AND ONE OF THE VALVE LEAFLETS BROKE OFF. THE VALVE HAD TO BE EXPLANTED. A NEW VALVE WAS THEN IMPLANTED". IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR AN AORTIC VALVE REPLACEMENT PROCEDURE. DURING PROCEDURE, AFTER SUTURING THE VALVE IN THE PATIENT THE PHYSICIAN ATTEMPTED TO TURN THE MECHANICAL VALVE WITH DIFFICULTY. THE PHYSICIAN TRIED AGAIN AND ONE OF THE VALVE LEAFLETS BROKE OFF. THE VALVE HAD TO BE EXPLANTED AND NEW UNKNOWN SIZE VALVE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014541 ↗
• MalfunctionMar 20, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM REGENT AORTIC MHV,FLEX C UFF WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE LEAFLET COATING PEELED FROM OUTER FRAME DURING IMPLANTATION. THE DEVICE WAS REPLACED WITH A 19MM REGENT AORTIC MHV,FLEX C UFF THAT WAS SUCCESSFULLY IMPLANTED AND COMPLETED THE PROCEDURE. THE PATIENT'S CONDITION IS STABLE. ABBOTT EMPLOYEE DID NOT PRESENT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18945259 ↗
• MalfunctionJan 9, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON 15 DECEMBER 2023 A 21MM REGENT MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANTATION. AFTER IMPLANT, THE LEAFLETS DID NOT OPEN. THE VALVE WAS EXPLANTED AND A NON-ABBOTT VALVE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475472 ↗
• MalfunctionJan 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS SELECTED FOR AN IMPLANT. IT WAS NOTED THAT DURING DEVICE PREPARATION THE LEAFLET FUNCTION FOR THE INITIAL VALVE WAS TESTED USING A NON-ABBOTT RUBBER SLEEVE AND FOUND THAT THE LEAFLETS WERE NOT MOVING NORMALLY. DURING THE PROCEDURE, AFTER IMPLANTATION, IT WAS FOUND THAT THE LEAFLETS DID NOT OPEN AND CLOSE WELL. THE DEVICE WAS EXPLANTED AND PHYSICIAN REPLACED WITH A NEW 21MM SJM REGENT HEART VALVE WITH FLEX CUFF THAT SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT WAS NOTED TO BE TAKING WARFARIN AS THEIR ANTI-THROMBOTIC MEDICATION. THE PATIENT'S LATEST INTERNATIONAL NORMALIZED RATIO (INR) WAS BETWEEN 2.0-3.0. THE PATIENT IS STABLE AT THE TIME OF REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439023 ↗
• InjuryDec 21, 2023Physical Resistance/Sticking; Intravalvular regurgitation; Physical Resistance/Sticking; Intravalvular regurgitation

  IT WAS REPORTED THAT ON 11 SEPTEMBER 2023, A 21MM REGENT AORTIC MECHANICAL VALVE WAS IMPLANTED SUCCESSFULLY. AFTER IMPLANTATION ON (B)(6) 2023, IT WAS REPORTED THAT THE BLOOD FLOW WAS UNSTABLE IN THE OPINION OF THE CARDIAC SURGEON. THERE WAS CENTRAL REGURGITATION AND THE LEAFLETS WOULD NOT OPEN EVENLY ON BOTH SIDES. THE PATIENT WAS REPORTED TO BE STABLE AND UNDER MONITORING.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18377717 ↗
• MalfunctionDec 20, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANT. AFTER SUTURING THE VALVE, PRIOR TO TAKING THE PATIENT OFF BYPASS, THE GRADIENT WAS OBSERVED TO INCREASE DUE TO ANATOMICAL CHALLENGES. IT WAS DECIDED TO EXPLANT THE VALVE. A REPLACEMENT 19MM SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS REPORTED TO BE DISCHARGED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364380 ↗
• MalfunctionDec 19, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS SELECTED FOR AN IMPLANT PROCEDURE IN A PATIENT WITH PRIOR AORTIC STENOSIS AND RESPIRATORY DISTRESS. IT WAS NOTED DURING PROCEDURE THAT THE VALVE HAD BEEN OVERSIZED AND WOULD NOT ENTER THE ANNULUS FULLY, BUT THE VALVE HAD ALREADY BEEN SUTURED. IT WAS NOTED THAT THE EVENT RESULTED IN EXACERBATION OF THE PATIENT'S AORTIC STENOSIS AND RESPIRATORY DISTRESS. THE DECISION WAS MADE TO REMOVE AND REPLACE THE 21MM SJM REGENT HEART VALVE WITH FLEX CUFF, WITH A 21MM EPIC SUPRA VALVE TO COMPLETE THE PROCEDURE. THERE WAS NO OTHER TREATMENT PERFORMED DUE TO THE PATIENT'S EXACERBATED AORTIC STENOSIS AND RESPIRATORY DISTRESS. THE PATIENT WAS NOT TAKEN OFF BYPASS DUE TO THIS EVENT. THE PATIENT WAS REPORTED AS STABLE AT THE TIME OF REPORT.

  Patient problems: Aortic Valve Stenosis; Respiratory Insufficiency

  MAUDE report 18360196 ↗
• MalfunctionDec 14, 2023Fracture; Fracture

  ON (B)(6), 2023, A REGENT MECHANICAL HEART VALVE 21AGFN-756 (SERIAL: (B)(6) WAS USED IN AN AORTIC VALVE REPLACEMENT SURGERY. DURING THE PROCESS OF IMPLANTING THE VALVE, IT WAS A CRACK WAS DISCOVERED IN THE VALVE FRAME, SO THE VALVE WAS REMOVED AND USED ANOTHER VALVE 21AGFN-756 (SERIAL: (B)(6) TO COMPLETE THE OPERATION. THE VALVE WAS ROTATED WITH THE VALVE ROTATOR, NO RESISTANCE WHILE ROTATING, NO INSTRUMENTS ENCOUNTERED THE VALVE AT THE TIME OF FRACTURE, HOLDER HANDLE WAS FULLY INSERTED INTO ORIFICE AT 90 DEGREE ANGLE, VALVE WAS IN CLOSED POSITION WHEN IT WAS ROTATED. THE PATIENT REMAINED ON CARDIOPULMONARY BYPASS THROUGHOUT THE PROCEDURE. THERE WAS A 20 MINUTE DELAY IN THE PROCEDURE THAT WAS CONSIDERED CLINICALLY ACCEPTABLE BY THE PHYSICIAN. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT'S CONDITION IS CURRENTLY STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329343 ↗
• MalfunctionNov 8, 2023Incomplete Coaptation; Physical Resistance/Sticking; Incomplete Coaptation; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM REGENT VALVE WAS CHOSEN FOR IMPLANTATION. ONCE IMPLANTED, THE VALVE LEAFLETS WOULD NOT OPEN OR CLOSE WHEN TESTING THE VALVE. IT WAS REPORTED THAT IT WAS POSSIBLE THAT THE VALVE WAS OVERSIZED. THE 21MM REGENT WAS REMOVED, AND A REPLACEMENT 19MM REGENT VALVE WAS IMPLANTED SUCCESSFULLY. AT THE END OF THE PROCEDURE, THE PATIENT HAD DIFFICULTY BEING REMOVED FROM CARDIOPULMONARY BYPASS (CPB). THE PATIENT WAS PLACED ON AN IMPELLA DEVICE. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL. ON AN UNKNOWN DATE, THE PATIENT DIED DUE TO AN UNKNOWN CAUSE. THE PHYSICIAN THOUGHT IT WAS UNRELATED TO THE VALVE AND THAT IT WAS POSSIBLY DUE TO UNDIAGNOSED PULMONARY HYPERTENSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092908 ↗
• InjuryNov 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED ON (B)(6) 2023 A 21MM SJM REGENT HEART VALVE WAS SELECTED FOR AN IMPLANT. AT THE TIME OF DEVICE PREPARATION, THE LEAFLETS WAS MOVING NORMALLY WHEN TESTED WITH RUBBER SUCTION TUBE. POST IMPLANT, THE PHYSICIAN FOUND THAT THE VALVE LEAFLET DID NOT OPEN AND CLOSE WELL, AND AFTER REMOVAL, A NEW 21MM SJM REGENT HEART VALVE WAS REIMPLANTED. THE PATIENT WAS GIVING WARFARIN WITH RECENT INTERNATIONAL NORMALIZED RATIO (INR) OF 1.8-2.0. THE PATIENT REMAIN STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092264 ↗
• InjuryOct 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT HEART VALVE WAS SUCCESSFULLY IMPLANTED IN A 55-YEAR-OLD PATIENT DUE TO SEVERE AORTIC REGURGITATION. ON (B)(6) 2023 THE PATIENT WENT TO THE HOSPITAL FOR FOLLOW-UP CONSULTATION AND FOUND THAT THE OPENING AND CLOSING OF THE VALVE LEAFLETS WAS RESTRICTED BY ULTRASONOGRAPHY, SEVERE AORTIC REGURGITATION, AND MODERATE MITRAL REGURGITATION WAS OCCURRING. SO THE DOCTOR DECIDED TO PERFORM A SECOND OPERATION TO REPLACE THE VALVE OF THE SAME TYPE ON (B)(6) 2023, A 21MM SJM REGENT HEART VALVE WAS IMPLANTED. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS IN STABLE CONDITION. THE PATIENT WAS PUT ON WARFARIN AND ASPIRIN POST IMPLANT WITH LATEST INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.5.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18038807 ↗
• MalfunctionOct 31, 2023Incomplete Coaptation; Detachment of Device or Device Component; Physical Resistance/Sticking; Incomplete Coaptation; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS CHOSEN FOR IMPLANT DURING AN AORTIC VALVE REPLACEMENT. ONCE THE VALVE WAS PLACED, IT WAS OBSERVED THAT ONE OF THE LEAFLETS DID NOT OPEN COMPLETELY DUE TO INTERFERENCE FROM THE MYOCARDIUM. THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. THERE WAS SOME RESISTANCE FELT WHEN ROTATING. THE VALVE WAS IN THE SEMI-OPEN POSITION DURING ROTATION. ON SECOND ATTEMPT WHEN THE VALVE WAS ROTATED WITH THE VALVE ROTATOR, THERE WAS RESISTANCE AGAIN, AND ONE OF THE LEAFLETS DISLODGED AS ONE PIECE. THE PIECE WAS RECOVERED FROM THE PATIENT. THE VALVE WAS REMOVED AND REPLACED WITH A 19MM SJM REGENT HEART VALVE WITH FLEX CUFF. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038612 ↗
• MalfunctionOct 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM REGENT AORTIC MHV,FLEX CUFF WAS SELECTED FOR AN IMPLANT. THE PHYSICIAN ROTATED THE VALVE WITH THE VALVE ROTATOR AND THE HOLDER HANDLE FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. DURING THE PROCEDURE, THE PHYSICIAN DISCOVERED THAT ONE LEAFLET WAS DETACHED AND WAS REMOVED FROM THE PATIENT. A 19MM REGENT AORTIC MHV,FLEX CUFF WAS SELECTED AND IMPLANTED AS A REPLACEMENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976640 ↗
• MalfunctionOct 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, WHILE LOWERING THE VALVE, ONE OF THE VALVE LEAFLETS DISLODGED AS ONE PIECE. AFTER MANIPULATING WITH FORCEPS/SURGICAL CLAMP, THE LEAFLET GOT FRACTURED. THE PIECES WERE RECOVERED FROM THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW 21MM SJM REGENT MECHANICAL HEART VALVE, THAT WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871061 ↗
• MalfunctionSep 20, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT HEART VALVE WAS SELECTED FOR AN IMPLANT. A RUBBER HOSE WAS USED TO TEST LEAFLET FUNCTION. DURING THE PROCEDURE, AFTER IMPLANTATION OF THE VALVE, THE PHYSICIAN FOUND THAT THE VALVE LEAFLET OPENED AND CLOSED ABNORMALLY, AND THEN REPLACED WITH A NEW 21MM SJM REGENT HEART VALVE THAT SUCCESSFULLY COMPLETED THE PROCEDURE. THE PATIENT RECEIVED WARFARIN SODIUM POST PROCEDURE. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785576 ↗
• MalfunctionAug 9, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED ON 14 JULY 2023, A 21MM SJM REGENT HEART VALVE W/ FLEX CUFF WAS CHOSEN FOR IMPLANT. IT WAS REPORTED AFTER IMPLANT, THE PHYSICIAN ATTEMPTED TO ROTATE THE VALVE WITH THE VALVE HOLDER. IT WAS REPORTED THE VALVE HOLDER WAS FULLY INSERTED INTO THE ORIFICE AT 90 DEGREE ANGLE AND THE VALVE WAS IN A CLOSED POSITION. THERE WAS A LITTLE RESISTANCE FELT WHEN ROTATING THE VALVE AND ONE LEAFLET FRACTURED INTO MULTIPLE PIECES AND DISLODGED FROM THE PIVOT POINT. IT WAS REPORTED DISLODGED LEAFLETS WERE COMPLETELY REMOVED FROM THE PATIENT. A DECISION WAS MADE TO EXPLANT THE VALVE AND REPLACED WITH A NEW 21MM SJM REGENT HEART VALVE W/ FLEX CUFF. THE REPLACEMENT VALVE WAS SUCCESSFULLY IMPLANTED WITH NO ADVERSE PATIENT CONSEQUENCES. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17494916 ↗
• MalfunctionAug 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM REGENT AORTIC MHV,FLEX C UFF WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE AND THERE WAS NO RESISTANCE FELT WHEN ROTATING THE VALVE. THE VALVE FRACTURED INSIDE THE PATIENT AT THE TIME OF IMPLANTATION AND WAS RECOVERED FROM THE PATIENT.DEVICE HAD TO BE REPLACED BY ANOTHER 19MM REGENT AORTIC MHV,FLEX C UFF. NO ANATOMICAL DAMAGE IS REPORTED IN THE PATIENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436134 ↗
• MalfunctionJul 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT MECHANICAL HEART VALVE WAS SELECTED FOR AN IMPLANTED. DURING THE PROCEDURE. THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE. DURING IMPLANT, ONE OF THE LEAFLET DISLODGED AFTER IMPLANT AND WAS RECOVERED FROM THE PATIENT. THE VALVE IN A CLOSED POSITION WHEN IT WAS ROTATED AND WHEN THE LEAFLET DISLODGED. DEVICE WAS EXPLANTED AND REPLACE WITH A NON-ABBOTT DEVICE. THERE WAS 15 MINUTES DELAY FOR REPLACEMENT PROCEDURES, NO ADVERSE EVENT CONSEQUENCES, THE PATIENT REMAIN HEMODYNAMICALLY STABLE, THROUGHOUT THE PROCEDURE. PATIENT STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405705 ↗
• MalfunctionJul 7, 2023Material Frayed; Device Damaged Prior to Receipt by User; Material Frayed; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT MECHANICAL HEART VALVE (FLEXCUFF), WAS SELECTED FOR AN IMPLANT. THE SURGEON REMOVED THE VALVE FROM THE OPERATING ROOM WAREHOUSE, OPENED THE PACKAGE AND FOUND THAT THE VALVE RING WAS PARTIALLY DAMAGED. THE PHYSICIAN DID NOT WANT TO WASTE THE VALVE AND THOUGHT THAT IMPLANTATION WOULD NOT AFFECT THE PERFORMANCE OF THE VALVE. THE PHYSICIAN ATTEMPTED IMPLANTING IT IN THE PATIENT BUT REMOVED IT DUE TO DIFFICULTY SUTURING. A NEW NON-ABBOTT VALVE WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT BOX CONTAINING THE DEVICE WAS ALSO NOTED TO HAVE BEEN DAMAGED. THE PATIENT IS STABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17282830 ↗
• InjuryJun 22, 2023Perivalvular Leak; Perivalvular Leak

  CRD_1036 - REGENT CHINA PMCF.(B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 21MM SJM REGENT AORTIC MECHANICAL HEART VALVE WAS IMPLANTED IN A PATIENT. THE PATIENT HAD HAD CHEST DISTRESS ON (B)(6) 2023, AND WAS DIAGNOSED WITH LUNG INFECTIONS ON (B)(6) 2023. ON (B)(6) 2023, THE RESULTS OF CARDIAC ULTRASOUND AND LEFT HEART FUNCTION MEASUREMENT SHOWED THAT THERE WAS A LARGE NUMBER OF REFLUXES AROUND THE ARTIFICIAL AORTA VALVE, CONSIDERING THE PARAVALVULAR LEAKAGE. THE PATIENT WAS TREATED WITH CARDIOTOSIS AND DIURESIS. THE PATIENT'S MENTAL CONDITION WAS IMPROVED, DIET WAS OK, SLEEP QUALITY WAS NORMAL, URINE AND FECES WERE NORMAL, COUGH WAS REPORTED BY PATIENT AND IT WAS LIKE STREAKS OF BLOOD IN SPUTUM ON (B)(6) 2023. THE PATIENT WAS TREATED WITH NEBULIZER THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17179057 ↗
• MalfunctionJun 19, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON(B)(6)2023, A 21MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS CHOSEN FOR IMPLANT. THE VALVE WAS NOT TESTED PRIOR TO IMPLANT. AFTER THE VALVE WAS IMPLANTED, THE LEAFLETS WERE TESTED WITH A RUBBER TUBE, AND IT WAS NOTED THAT THE VALVE LEAFLET DID NOT OPEN AND CLOSE WELL. THE VALVE WAS REMOVED AND A NEW 19MM SJM REGENT HEART VALVE WITH FLEX CUFF WAS SUCCESSFULLY IMPLANTED INTERPROCEDURALLY. THE PATIENT WAS REPORTED AS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17152507 ↗
• DeathMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ABSTRACT ARTICLE, "TRIFECTA BIOPROSTHESES: EVALUATION OF THE SAFETY BASED ON THE STUDY OF DEGENERATIONS ACCORDING TO THE VARC-3 CLASSIFICATION", WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO EVALUATE THE INTRINSIC IMPUTABILITY OF TRIFECTA FOR DYSFUNCTION ACCORDING TO THE VARC-3 CLASSIFICATION IN PATIENTS IMPLANTED AND TO REASSESS THEIR REFERENCING IN OUR CENTER. TRIFECTA VALVE WAS THE DEVICE ASSOCIATED WITH THIS STUDY. THE ARTICLE CONCLUDED, THE CLASSIFICATION OF FAILURES ACCORDING TO VARC-3 INDICATED THE INTRINSIC IMPUTABILITY OF THE TRIFECTA¿ BIOPROSTHESES REGARDING TO THE NUMBER OF SVD-TYPE DYSFUNCTIONS. ALTHOUGH THIS STUDY HAS LIMITATIONS, IT SHOWS THE UNDERSTATEMENT OF MEDICAL-DEVICES-VIGILANCE CASES BY THE MEDICAL STAFF. [THE PRIMARY AUTHOR OF THIS ARTICLE IS RICHEZ, OPHELIE, AMIENS-PICARDIE UNIVERSITY HOSPITAL, 1 ROND-POINT DU PROFESSEUR CHRISTIAN CABROL, 80054 AMIENS, FRANCE, WITH EMAIL ADDRESS OF : [email protected]]. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN FEBRUARY OF 2013, A 23MM TRIFECTA VALVE WAS IMPLANTED FOR NATIVE VALVE ENDOCARDITIS OF A 37 YEAR OLD PATIENT. THE TRIFECTA WAS IMPLANTED AT THE AORTIC AND THE PERIMO

  Patient problems: Adult Respiratory Distress Syndrome; Sepsis

  MAUDE report 16858592 ↗