SJM™ RSAR-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05414734009461), received between Sep 8, 2021 and Feb 16, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Incomplete Coaptation” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022 A 34MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED. POST PROCEDURE THE PATIENT HAD PAROXYSMAL ATRIAL FIBRILLATION, WHICH WAS TREATED WITH MEDICATION. ON (B)(6) 2022, AN MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED AND REVEALED THAT THE PATIENT WAS HAD AN OLD CEREBRAL VASCULAR ACCIDENT (CVA), MOST LIKLEY DURING/AFTER SURGERY. THERE WAS NO TREATMENT PROVIDED, BUT THE RESULTING CHRONIC SEQUELA WAS DAILY MIGRAINES. THE PATIENT IS DOING OK. THOUGH THEY STILL SOME PAIN DUE ON SITE OF THE OPERATION WOUND, COMPLAINTS OF ATRIAL FIBRILLATION ONCE EVERY THREE DAYS, AND HAS EMOTIONAL IMPACT DUE TO THE OPERATION. THE PATIENT IS UNDER THE CARE OF A PSYCHOLOGIST.

  Patient problems: Atrial Fibrillation; Emotional Changes; Headache; Pain; Stroke/CVA

  MAUDE report 16387117 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL INFORMATION: CRD_985 - ARB PMCF, PATIENT SITE ID: DE4432-481, R735088301. IT WAS REPORTED THAT ON (B)(6) 2023, A 34MM RIGID SADDLE RING WAS SUCCESSFULLY IMPLANTED IN A PATIENT. THE PATIENT'S MITRAL VALVE REPAIR ALSO INVOLVED A POSTERIOR LEAFLET CUT (P2), ALONG WITH CHORDAL REPLACEMENT WITH ARTIFICIAL CHORDAE OR SUTURE. IT WAS NOTED THAT A LEFT ATRIAL APPENDAGE CLOSURE AND PATENT FORAMEN OVALE (PFO) CLOSURE WERE ALSO PERFORMED DURING THE SAME SURGERY. ON (B)(6) 2023, IT WAS NOTED VIA COMPUTED TOMOGRAPHY SCAN THAT THE PATIENT WAS SUFFERING FROM HEMOTHORAX. THE DECISION WAS MADE TO PERFORM A SURGICAL PROCEDURE TO SUCCESSFULLY REMOVED THE HEMATOMA. THERE WAS NO BLEEDING NOTED DURING THE SURGICAL PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Hemothorax

  MAUDE report 16380782 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 34MM RIGID SADDLE RING WAS IMPLANTED. AN ATRIAL SEPTAL DEFECT WAS ALSO CLOSED DURING THE PROCEDURE. AFTER THE PROCEDURE, THERE WAS MAJOR BLEEDING. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE A HEMATOMA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 14459701 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 34MM RIGID SADDLE RING WAS IMPLANTED. POST PROCEDURE ON THE SAME DAY, THE PATIENT DEVELOPED A NEW ONSET OF ATRIAL FIBRILLATION. ON (B)(6) 2021, THE PATIENT WAS CARDIOVERTED AND AMIODARONE WAS STARTED. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Atrial Fibrillation

  MAUDE report 14142108 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2022, A 34MM SJM RIGID SADDLE RING WAS SELECTED FOR IMPLANT. DURING IMPLANT PROCEDURE, BLEEDING AT THE LEFT ATRIAL APPENDAGE (LAA) WAS NOTED DUE TO THE AORTIC CLAMP OR MANIPULATION INTRA ATRIAL. AN ATRICLIP WAS IMPLANTED IN LAA. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS DISCHARGED TO REFERRING HOSPITAL ON (B)(6) 2022. (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13385180 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 34MM SJM RIGID SADDLE RING WAS IMPLANTED. POST IMPLANT PROCEDURE ON (B)(6) 2021, A PNEUMOTHORAX WAS NOTED AND THE PATIENT RECEIVED THORAX DRAINS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND WAS DISCHARGED ON (B)(6) 2021. THE PNEUMOTHORAX WAS STILL PRESENT AT DISCHARGE AND THE PATIENT WILL PRESENT BACK TO THE HOSPITAL ON (B)(6) 2022 FOR A FOLLOW-UP. ((B)(4)).

  Patient problems: Pneumothorax

  MAUDE report 12891546 ↗
• InjuryNov 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, A 34MM SJM RIGID SADDLE RING WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT PRESENTED WITH HYPOTENSION, PLEURAL FLUID BIBASAL AND ATELECTASIS DUE TO THE IMPLANT PROCEDURE. A PERICARDIAL EFFUSION WAS NOT NOTED. ON (B)(6) 2021, FUROSEMIDE WAS GIVEN AND EVENT WAS RESOLVED ON (B)(6) 2021, RESOLVED WITH SEQUELAE. THE PATIENT DOES NOT HAVE A HISTORY OF HYPOTENSION. THERE WERE NO PROCEDURE COMPLICATIONS AND THE RING IS PERFORMING AS INTENDED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. (B)(4).

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 12755805 ↗
• InjurySep 8, 2021Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2021, A 34MM SJM RIGID SADDLE RING WAS IMPLANTED IN THE MITRAL POSITION. ON (B)(6) 2021, THE PATIENT PRESENTED WITH INTERMITTENT SHORT TERM SUPRAVENTRICULAR TACHYCARDIA AND MITRAL VALVE PROLAPSE (MVP) AND MEDICATION WAS STOPPED. THE PATIENT WAS EXPERIENCING DYSPNEA AND PALPITATIONS DUE TO THE MVP. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE MVP. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) EXPERIENCING PALPITATIONS AND AN ELECTROCARDIOGRAM (ECG) WAS PERFORMED AND NOTED ATRIAL FIBRILLATION, WITH A FAST VENTRICULAR RESPONSE AND SECONDARY REPOLARIZATION DISORDER WAS REPORTED. THE PATIENT RECEIVED 300MG OF AMIODARONE WHICH RESOLVED THE ARRHYTHMIA AND COVERED TO SINUS RHYTHM. THIS IS MOST LIKELY DUE TO THE IMPLANT PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND IS NOW HOME. ON (B)(6) 2021, THE PATIENT PRESENT TO THE HOSPITAL WITH A HEADACHE AND LOW BLOOD PRESSURE. A TEE WAS PERFORMED FOR RULE OUT PERICARDIAL FLUID. NO PERICARDIAL FLUID WAS NOTED.

  Patient problems: Atrial Fibrillation; Dyspnea; Headache; Heart Block; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 12439100 ↗