SJM Masters SeriesRecalls & reported problems across all models

We found 27 models of SJM Masters Series by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 150 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2018 and Aug 18, 2025 — classified as 16 deaths, 111 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fracture” (22 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 SJM Masters Series problems

SJM Masters Series models

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

• SJM™ Masters Series 27MJ-501

  HEART-VALVE, MECHANICAL
  1 death21 reports
• SJM™ Masters Series 29MJ-501

  HEART-VALVE, MECHANICAL
  3 deaths18 reports
• SJM™ Masters Series 27MECJ-502

  HEART-VALVE, MECHANICAL
  3 deaths14 reports
• SJM™ Masters Series 29MECJ-502

  HEART-VALVE, MECHANICAL
  11 reports
• SJM™ Masters Series 21AECJ-502

  HEART-VALVE, MECHANICAL
  1 death9 reports
• SJM™ Masters Series 25MJ-501

  HEART-VALVE, MECHANICAL
  8 reports
• SJM™ Masters Series 15MHPJ-505

  HEART-VALVE, MECHANICAL
  2 deaths8 reports
• SJM™ Masters Series 31MJ-501

  HEART-VALVE, MECHANICAL
  7 reports
• SJM™ Masters Series 25MECJ-502

  HEART-VALVE, MECHANICAL
  1 death6 reports
• SJM™ Masters Series 31MECJ-502

  HEART-VALVE, MECHANICAL
  6 reports
• SJM™ Masters Series AJ-501

  HEART-VALVE, MECHANICAL
  2 deaths6 reports
• SJM™ Masters Series 19AECJ-502

  HEART-VALVE, MECHANICAL
  6 reports
• SJM™ Masters Series 15AHPJ-505

  HEART-VALVE, MECHANICAL
  1 death5 reports
• SJM™ Masters Series 23MECJ-502

  HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series 33MJ-501

  HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series AJ-501

  HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series 25MTJ-503

  HEART-VALVE, MECHANICAL
  3 reports
• SJM™ Masters Series 23MJ-501

  HEART-VALVE, MECHANICAL
  2 reports
• SJM™ Masters Series AJ-501

  HEART-VALVE, MECHANICAL
  1 death2 reports
• SJM™ Masters Series 27MTJ-503

  HEART-VALVE, MECHANICAL
  2 reports
• SJM™ Masters Series 21MECJ-502

  HEART-VALVE, MECHANICAL
  1 death1 report
• SJM™ Masters Series MECJ-502

  HEART-VALVE, MECHANICAL
  1 report
• SJM™ Masters Series AJ-501

  HEART-VALVE, MECHANICAL
  1 report
• SJM™ Masters Series 25ATJ-503

  HEART-VALVE, MECHANICAL
  1 report
• SJM™ Masters Series 21ATJ-503

  HEART-VALVE, MECHANICAL
  1 report
• SJM™ Masters Series 23MTJ-503

  HEART-VALVE, MECHANICAL
  1 report
• SJM™ Masters Series 25AECJ-502

  HEART-VALVE, MECHANICAL
  1 report

Recent SJM Masters Series adverse event reports

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

• InjuryAug 18, 2025Patient Device Interaction Problem; Physical Resistance/Sticking; Patient Device Interaction Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 23MM MASTERS SERIES HEART VALVE WITH EXPANDED TEFLON WAS IMPLANTED. THE LEAFLETS WERE FUNCTIONING NORMALLY UNTIL EARLY (B)(6) 2025. ON (B)(6) 2025, THERE WAS "CONCERN THAT THE VALVE MAY HAVE BECOME STUCK." ECHOCARDIOGRAPHY WAS PERFORMED WHICH SHOWED STUCK LEAFLETS. THROMBUS HAD ACCUMULATED AT THE PIVOT AND THE VALVE WAS EXPLANTED. UPON EXPLANT, LEAFLET FUNCTION WAS TESTED AND "WERE STUCK DUE TO MATERIAL ADHERED TO THE PIVOT." A NEW 25MM NON-ABBOTT DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22833926 ↗
• MalfunctionJul 19, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 23MM MITRAL MASTERS VALVE WAS SELECTED FOR IMPLANT. THE VALVE WAS SIZED WITH A 905 ABBOTT SIZER SET. DURING DEVICE PREPARATION, THE LEAFLETS WERE TESTED AND MOVING NORMALLY. AFTER IMPLANT, THE VALVE LEAFLETS WERE TESTED WITH A TESTER AND THE VALVE DID NOT CLOSE COMPLETELY; THE LEAFLETS DID NOT HAVE DIFFICULTY OPENING COMPLETELY. THEREFORE, THE VALVE WAS EXPLANTED; THE PATIENT HAD NOT BEEN CLOSED PRIOR TO EXPLANTING THE VALVE. UPON EXPLANT, THE LEAFLET WAS NOT TESTED AGAIN; A NEW 25MM MITRAL MASTERS VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT'S ANTITHROMBOTIC REGIMEN CONSISTED OF HEPARIN; THE PATIENT'S LATEST INTERNATIONAL NORMALIZED RATIO (INR) AND INR HISTORY ARE UNKNOWN. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19784680 ↗
• MalfunctionApr 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2024, A 27MM MASTERS MITRAL MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANTATION. PATIENT WAS ON WARFARIN. INTERNATIONAL NORMALIZED RATIO WAS 1.8. DURING PREPARATION, THE LEAFLETS FUNCTIONED NORMALLY. FLAP HOLDER WAS USED TO TEST LEAFLET FUNCTION. ONCE IMPLANTED, THE VALVE LEAFLETS BECAME STUCK AND MOVEMENT WAS RESTRICTED. THE VALVE WAS EXPLANTED AND A REPLACEMENT 27MM MASTERS MITRAL MECHANICAL HEART VALVE WAS IMPLANTED SUCCESSFULLY. ONCE THE VALVE WAS EXPLANTED, THE LEAFLETS FUNCTIONED NORMALLY. THERE WERE NO PATIENT CONSEQUENCES. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194323 ↗
• MalfunctionDec 29, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON 05 DECEMBER 2023, A 29MM MITRAL MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANT. A RESISTANCE WAS MET WHEN ROTATING THE VALVE WITH THE VALVE ROTATOR. THE VALVE WAS PLACED ON THE MITRAL VALVE. DURING SUTURING OF THE VALVE, IT WAS OBSERVED THAT THE VALVE LEAFLET DISLODGED AS ONE PIECE. THE VALVE WAS OPENED AND REMOVED. THE INTACT LEAFLET WAS RECOVERED FROM THE PATIENT. A 29MM NON-ABBOTT REPLACEMENT VALVE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416462 ↗
• InjuryDec 19, 2023Perivalvular Leak; Perivalvular Leak

  THE ARTICLE, "3D PRINTING FROM TRANSESOPHAGEAL ECHOCARDIOGRAPHY FOR PLANNING MITRAL PARAVALVULAR LEAK CLOSURE ¿ FEASIBILITY STUDY", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A PATIENT THE UNDERWENT MITRAL VALVE REPLACEMENT SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS IMPLANTED. IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH PARAVALVULAR LEAK OF THE MITRAL PROSTHESIS VALVE. A DECISION WAS MADE TO IMPLANT A 12-5MM OCCLUTECH PARAVALVULAR LEAK DEVICE. THE PATIENT STATUS WAS REPORTED STABLE AFTER ONE YEAR FOLLOW UP. THE ARTICLE CONCLUDED 3D-PRINTING FROM 3D-TEE IS TECHNICALLY FEASIBLE. BOTH SHAPE AND LOCATION OF PVLS ARE PRESERVED DURING MODEL PREPARATION AND PRINTING. IT REMAINS TO BE TESTED WHETHER 3D PRINTING WOULD IMPROVE OUTCOMES OF PERCUTANEOUS PVL CLOSURE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS MAREK JEDRZEJEK, DEPARTMENT OF CARDIOLOGY AND STRUCTURAL HEART DISEASES, MEDICAL UNIVERSITY OF SILESIA, KATOWICE, POLAND, WITH CORRESPONDING E-MAIL: [email protected]].

  Patient problems: Insufficient Information

  MAUDE report 18356646 ↗
• MalfunctionAug 18, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2022, A 33MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS CHOSEN FOR IMPLANT. AFTER THE VALVE WAS IMPLANTED, IT WAS FOUND THE VALVE COULD NOT BE ROTATED. IT WAS REPORTED THE HOLDER HANDLE WAS FULLY INSERTED INTO THE ORIFICE AT 90 DEGREE ANGLE AND NO OTHER TOOL WAS USED TO POSITION OR ROTATE THE VALVE. A DECISION WAS MADE TO EXPLANT THE DEVICE AND REPLACE WITH A 33MM NON-ABBOTT VALVE. 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 STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574582 ↗
• InjuryAug 1, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON 11 JULY 2023, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE WAS SELECTED FOR IMPLANT IN THE PATIENT. AFTER IMPLANTATION OF THE VALVE, THE PHYSICIAN CLOSED THE INCISION OF HEART. THE PHYSICIAN FOUND THAT ONE LEAFLETS COULDN'T MOVE DURING TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PHYSICIAN STOPPED THE BLOOD CIRCULATION AND OPENED THE HEART INCISION AGAIN. HE USED A TESTER OF SILICON TO TEST THE LEAFLET FUNCTION AND FOUND THAT ONE LEAFLET COULDN'T MOVE NORMALLY. SO, THE PHYSICIAN HAD TO EXPLANT THE VALVE, AND REPLACED A NEW 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE. ONCE EXPLANTED, THE ORIGINAL VALVE LEAFLET WAS NOT MOVING NORMALLY. THE PROCEDURE TIME WAS EXTENDED ABOUT 60 MINUTES. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS STABLE IN THE POST OPERATIVE RECOVERY PERIOD. THE PATIENT WAS TAKING WARFARIN, AND THE LATEST INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.0-2.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435937 ↗
• InjuryJun 16, 2023Incomplete Coaptation; Patient-Device Incompatibility; Device Stenosis; Incomplete Coaptation; Patient-Device Incompatibility; Device Stenosis

  IT WAS REPORTED THAT ON (B)(6) 2002, A 21MM MASTERS SERIES HEART VALVE WITH TEFLON CUFF WAS SUCCESSFULLY IMPLANTED IN A PATIENT'S AORTIC VALVE. IN (B)(6) 2023, THE PATIENT HAD A MEDICAL EXAMINATION AND THE PATIENT DISPLAYED SYMPTOMS OF AORTIC STENOSIS: SHORTNESS OF BREATH/DYSPNEA ON EXERTION. AN ECHOCARDIOGRAM (ECHO) WAS PERFORMED, AND MILD-MODERATE AORTIC STENOSIS WAS CONFIRMED. IN MAY, THE AORTIC STENOSIS PROGRESSED, AND IT WAS DECIDED THAT VALVE REPLACEMENT WAS NECESSARY. ON (B)(6) 2023, THE DEVICE WAS EXPLANTED AND A 19MM EPIC VALVE WAS IMPLANTED. PANNUS WAS SEEN CIRCUMFERENTIALLY ON THE INFLOW SIDE OF THE MASTERS VALVE, WHICH INDICATED THAT THE VALVE WAS NOT COMPLETELY OPENING. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 17144562 ↗
• InjuryMay 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE MITRAL STANDARD CUFF WAS SELECTED FOR AN IMPLANT. AT THE TIME OF DEVICE PREPARATION, THE LEAFLETS WAS MOVING NORMALLY WHEN TESTED. DURING THE PROCEDURE, AFTER THE IMPLANTATION OF THE VALVE, THE PHYSICIAN CLOSED THE INCISION OF HEART. THE PHYSICIAN FOUND THAT ONE LEAFLET COULDN'T MOVE DURING THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). HE STOPPED THE BLOOD CIRCULATION AND OPENED THE HEART INCISION AGAIN. HE USED A TESTER OF SILICON TO TEST THE LEAFLET FUNCTION, FOUND THAT THE LEAFLETS COULD OPEN AND CLOSE NORMALLY. THE PHYSICIAN CLOSED THE INCISION OF HEART, BUT THAT LEAFLET COULDN'T MOVE AGAIN. DEVICE WAS EXPLANTED, AND REPLACED A NEW 27MM SJM MASTERS SERIES MECHANICAL HEART VALVE MITRAL STANDARD CUFF THAT WAS IMPLANTED AND LEAFLETS MOVED NORMALLY. THE PROCEDURE TIME WAS EXTENDED ABOUT 90 MINUTES. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE. THE PATIENT WAS GIVEN WARFARIN AND AND INR WAS 2.5. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND IS CURRENTLY STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17034103 ↗
• MalfunctionMay 19, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2023 A 19MM SJM MASTERS SERIES VALVE W/ EXPANDED CUFF WAS CHOSEN FOR IMPLANT. THE PATIENT'S AORTIC ANNULUS WAS SIZED 19MM VIA A MECHANICAL SIZER SET. AFTER THE DEVICE WAS IMPLANTED, THE OPERATOR ATTEMPTED TO ROTATE THE VALVE IN SITU, FELT RESISTANCE, AND WAS UNABLE TO ROTATE WHEN ONE OF THE LEAFLETS HAD FRACTURED INTO THREE PIECES. IT WAS REPORTED NO OTHER INSTRUMENTS ENCOUNTERED THE VALVE AT THE TIME OF FRACTURE AND ALL OF THE LEAFLET FRACTURED PIECES WERE REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED ONLY THE HOLDER HANDLE WAS USED TO ROTATE THE VALVE, THE HOLDER HANDER WAS FULLY INSERTED INTO THE ORIFICE AT A 90 DEGREE ANGLE, AND THE VALVE WAS IN A CLOSED POSITION WHEN ROTATED. A DECISION WAS MADE TO EXPLANT THE VALVE AND A NEW 19MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED IN THE PATIENT 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 THEIR STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16969670 ↗
• InjuryMay 18, 2023Incomplete Coaptation; Patient Device Interaction Problem; Incomplete Coaptation; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 29MM MITRAL MASTERS SERIES STD VALVE WAS SELECTED FOR IMPLANT IN THE PATIENT. AT THE TIME OF DEVICE PREPARATION, THE LEAFLETS WERE MOVING NORMALLY. AFTER IMPLANTATION OF THE VALVE, THE PHYSICIAN CLOSED THE INCISION OF HEART. THE PHYSICIAN FOUND THAT ONE LEAFLET OF VALVE COULDN'T MOVE DURING THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THEN THE PHYSICIAN STOPPED THE BLOOD CIRCULATION AND OPENED THE HEART INCISION AGAIN. HE FOUND THAT THERE WAS SOME THROMBUS IN THE PIVOT OF VALVE WHICH AFFECTED THE FUNCTION OF ONE LEAFLET. SO THE PHYSICIAN EXPLANTED THE VALVE, THEN REPLACED WITH A NON-ABBOTT DEVICE. THE PROCEDURE TIME WAS EXTENDED ABOUT 45 MINUTES. THE PATIENT WAS GIVEN HEPARIN WITH ACTIVATED CLOTTING TIME (ACT) OF >500 SECONDS. THE PROCEDURE WAS FINISHED SUCCESSFULLY WITHOUT PATIENT CONSEQUENCE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND IS CURRENTLY SAFE AND STABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16954194 ↗
• MalfunctionMay 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6)2023, A 19MM MASTERS SERIES VALVE EXPANDED CUFF WAS SELECTED FOR AN IMPLANT. THE SURGEON SIZED THE AORTIC ANNULUS WITH THE HELP OF 905 SIZER SET, WHILE ROTATING THE VALVE ONE OF THE LEAFLET FOUND BROKEN INTO TWO PIECES AND WAS RECOVERED FROM THE PATIENT. DEVICE WAS EXPLANTED, AND A NEW 19MM MASTERS SERIES VALVE EXPANDED CUFF WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943711 ↗
• InjuryApr 7, 2023Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT ON (B)(6) 2018, A 25MM SJM MASTERS SERIES HEART VALVE WITH TEFLON CUFF WAS SUCCESSFUL IMPLANTED. ON (B)(6) 2023, THE PATIENT PRESENTED WITH INFECTIVE ENDOCARDITIS AND A RE-DO PROCEDURE WAS PERFORMED. THERE WAS NO PARTICULAR PROBLEM DUE TO IT BEING A MECHANICAL VALVE, BUT REOPERATION WAS PERFORMED BECAUSE OF PARA-VALVULAR LEAK. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER 25MM SJM MASTERS SERIES HEART VALVE WITH TEFLON CUFF. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A FEVER DUE TO THE INFECTIVE ENDOCARDITIS. THE PATIENT DOES NOT HAVE ANY HISTORY OF ENDOCARDITIS. THE PATIENT DOES NOT HAVE A HISTORY AN INDWELLING VASCULAR CATHETER, INTRAVENOUS DRUG USE, RECENT DENTAL WORK, OR INJURY FROM A NON-STERILE OBJECT. THE PARAVALVULAR LEAK IS BELIEVED TO HAVE BEEN A RESULT OF THE INFECTIVE ENDOCARDITIS. THE IMPLANTING PHYSICIAN BELIEVES THAT THE CAUSE OF THE ENDOCARDITIS IS DUE TO A PATIENT CONDITION. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: Endocarditis; Fever

  MAUDE report 16704681 ↗
• MalfunctionApr 6, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2022, A 27MM SJM MASTERS SERIES VALVE EXPANDED CUFF WAS SELECTED FOR IMPLANTATION INTO A PATIENT. DURING THE PROCEDURE, DURING IMPLANTATION, A LEAFLET DISLODGED FORM THE DEVICE, FRACTURED INTO TWO PIECES, AND FELL INTO THE LEFT VENTRICLE. THE LEAFLET PIECES WERE RETRIEVED, AND THE VALVE WAS REPLACED WITH A 25MM SJM MASTERS SERIES VALVE EXPANDED CUFF. IT WAS REPORTED THAT THE PATIENT IS STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691926 ↗
• MalfunctionApr 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 27MM SJM MASTERS SERIES HEART VALVE WITH TEFLON CUFF WAS CHOSEN FOR PROCEDURE. DURING THE PROCEDURE, THE VALVE WAS REMOVED DUE TO THE SIZE DIFFERENCE AND THERE WAS DIFFICULTY PARACHUTING THE DEVICE INTO THE ANNULUS. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT VALVE AS A REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691288 ↗

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