Minima Stent System - 6mm FG-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00196852801862), received between Dec 11, 2024 and Jul 1, 2026 — classified as 1 death, 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Migration

  A 6 MM MINIMA STENT WAS IMPLANTED IN THE RIGHT PULMONARY ARTERY (RPA) TO TREAT RPA STENOSIS ON (B)(6) 2026. DURING THE INDEX PROCEDURE, STENT MIGRATION AND INTRAPULMONARY HEMORRHAGE WAS REPORTED TO RENATA MEDICAL. DURING A ROUTINE ECHOCARDIOGRAM PERFORMED ON (B)(6) 2026, THE STENT WAS FOUND TO HAVE FURTHER MIGRATED AND WAS LOCATED ADJACENT TO THE RIGHT VENTRICULAR (RV) WALL. THE PATIENT WAS HOSPITALIZED AND UNDERWENT SURGICAL REMOVAL OF THE STENT WITH REPLACEMENT OF THE RV-PA CONDUIT ON (B)(6) 2026. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25685870 ↗
• InjuryJun 2, 2026Migration

  A 6 MM MINIMA STENT WAS USED TO TREAT A NATIVE COARCTATION ON (B)(6) 2025. NO INTRA-PROCEDURAL COMPLICATIONS OR ADVERSE EVENTS WERE REPORTED TO RENATA MEDICAL AT THE TIME OF THIS PROCEDURE. ON (B)(6) 2026, A FOLLOW-UP CATHETERIZATION PROCEDURE WAS PERFORMED DUE TO AN INCREASED GRADIENT IDENTIFIED DURING CLINICAL EVALUATION. DURING THIS PROCEDURE, STENT MIGRATION AND A POSTERIOR MEDIAL ANEURYSM WERE OBSERVED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL DEVICE PERFORMANCE DATA INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aneurysm

  MAUDE report 25368257 ↗
• DeathApr 9, 2026Adverse Event Without Identified Device or Use Problem

  THE MINIMA STENT WAS REPORTED IN A SEVERE ADVERSE EVENT DURING PATIENT PARTICIPATION IN THE MINIMA POST-APPROVAL STUDY (B)(6). A 6MM MINIMA STENT WAS USED TO TREAT AN AORTIC COARCTATION ON (B)(6) 2026. THE STENT PLACEMENT RELIEVED THE PRESSURE GRADIENT, AND ANGIOGRAM CONFIRMED A SUCCESSFUL RESULT. ON (B)(6) 2026, THE PATIENT BECAME BRADYCARDIC AND WAS PLACED ON ECMO FOLLOWING 45 MINUTES OF CPR WITHOUT RETURN OF SPONTANEOUS CIRCULATION. ON (B)(6) 2026, IMAGING REVEALED ISCHEMIC STROKE, THE PATIENT WAS DISCONTINUED FROM ECMO SUPPORT AND PRONOUNCED DECEASED. NO DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Bradycardia; Cardiac Arrest; Convulsion/Seizure; High Blood Pressure/ Hypertension; Tachycardia

  MAUDE report 24837886 ↗
• MalfunctionMar 24, 2026Device Dislodged or Dislocated

  AN 8MM MINIMA STENT WAS USED IN A PROCEDURE TO TREAT A NATIVE COARCTATION IN A VESSEL LARGER THAN THE STENT'S LABELED IMPLANTABLE RANGE. PRIOR TO THE PROCEDURE, THE PHYSICIAN REMOVED THE STENT FROM THE BALLOON TO MODIFY THE STENT. WHEN DEPLOYED, THE STENT MISSED THE TARGET LOCATION. THOUGH THE STENT WAS STABLE AT THE END OF THE PROCEDURE, AN X-RAY LATER IDENTIFIED THE STENT HAD MOVED FROM THE DEPLOYMENT LOCATION INTO THE BRACHIOCEPHALIC ARTERY. A FOLLOW-UP PROCEDURE WAS PERFORMED TWO DAYS LATER TO PLACE AN ADDITIONAL 8MM MINIMA STENT IN THE STENOSIS AND FURTHER FIXATE THE FIRST STENT. NO DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683215 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, TWO 6MM MINIMA STENTS WERE USED TO TREAT NATIVE COARCTATION. THE INITIAL STENT MOVED FROM THE INITIAL PLACEMENT LOCATION DUE TO DIFFICULT LOCATION AND SIZING OF THE LESION. AFTER THE SECOND STENT WAS PLACED, THERE WERE NO ADVERSE EVENTS RECORDED AND THE LESION WAS TREATED. DURING FOLLOW UP, IT WAS DETERMINED THAT SURGICAL INTERVENTION WOULD BE PURSUED DUE TO PERSISTING HYPOPLASTIC TRANSVERSE ARCH. IT WAS ACKNOWLEDGED THAT THE STENT COULD BE REDILATED, BUT THE HYPOPLASTIC TRANSVERSE ARCH WOULD REQUIRE SURGERY, SO BOTH WERE ADDRESSED DURING SURGERY. ON (B)(6) 2026, THE STENT WAS PARTIALLY CUT THROUGH LONGITUDINALLY DURING A PROCEDURE TO RECONSTRUCT THE AORTIC ARCH AS WELL AS TREAT THE MEASURED GRADIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565249 ↗
• MalfunctionFeb 2, 2026Patient Device Interaction Problem

  AN 8MM MINIMA STENT WAS USED TO TREAT A STENOSIS IN THE RIGHT PULMONARY ARTERY. THE STENT WAS DEPLOYED IN THE PROXIMAL RPA SUCH THAT IT COVERED THE OSTIUM AND OVERLAPPED INTO AN EXISTING STENT. THE FINAL STENT POSITION WAS INFLUENCED BY INTERACTION WITH INSTRUMENTATION DURING REMOVAL. THE IMPLANT WAS FIXATED IN THE SVC USING AN OFF-THE-SHELF BALLOON. AN OFF-THE-SHELF STENT WAS USED TO TREAT THE STENOSIS. NO DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240777 ↗
• MalfunctionOct 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  AN 8 MM MINIMA STENT WAS USED DURING A COA PROCEDURE WITH CAROTID ACCESS. THE STENT WAS PLACED CENTRALLY ACROSS THE COA AND DEPLOYED AT THE NOMINAL PRESSURE. THE STENT MOVED DISTALLY FROM THE LESION AS THE BALLOON WAS EXTRACTED. AN OFF-THE-SHELF 9 MM BALLOON CATHETER WAS USED TO IMPROVE STENT FIXATION. THERE WAS NO ADDITIONAL INTERVENTION NEEDED FOR THE COARCTATION, AS THE STENOSIS APPEARED TO BE RELIEVED. NO DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23317625 ↗
• MalfunctionAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE 6MM MINIMA STENT WAS USED TO TREAT AN AORTIC RE-COARCTATION. AFTER THE STENT WAS PLACED, THE PHYSICIAN ATTEMPTED TO IMPROVE FIXATION BY POST-DILATING THE STENT WITH THE SAME BALLOON. WHEN THE BALLOON WAS DEFLATED, IMAGING IDENTIFIED THAT THE STENT MIGRATED DISTALLY THROUGH THE DESCENDING AORTA SUCH THAT IT NO LONGER TREATED THE STENOSIS. A SECOND SYSTEM WAS TRACKED TO THE LESION AND AS THE BALLOON WAS EXPOSED, THE OUTER SHAFT PULLED THE FIRST IMPLANT FURTHER DISTALLY IN THE DESCENDING AORTA. THE SECOND STENT RESULTED IN SUCCESSFUL STENOSIS RELIEF AND MAINTAINED FIXATION WITHIN THE VESSEL. THE FIRST IMPLANT WAS POST-DILATED WITH AN OFF-THE-SHELF BALLOON TO PREVENT FURTHER MIGRATION. NO DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22810068 ↗
• MalfunctionMar 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE 6 MM MINIMA STENT WAS USED TO TREAT A LEFT PULMONARY ARTERY (LPA) STENOSIS WITH DIFFICULT UNDERLYING VESSEL CONDITIONS. AFTER THE STENT WAS PLACED, FINAL ANGIOGRAMS CONFIRMED THE STENT WAS PROPERLY LOCATED SO THE MINIMA SYSTEM AND GUIDEWIRE WERE REMOVED. FOLLOWING THE MINIMA IMPLANT, THE PHYSICIAN PROCEEDED WITH AN UNRELATED PROCEDURE, AFTER WHICH FLUOROSCOPY REVEALED THAT STENT SHIFTED TOWARDS THE MAIN PULMONARY ARTERY (MPA). THE PHYSICIAN INTERVENED AND SUCCESSFULLY REPOSITIONED THE STENT INTO THE RIGHT PULMONARY ARTERY (RPA) USING A GUIDEWIRE. THE STENT STABILIZED IN THE RPA WITHOUT A BALLOON AND THE STENOSIS WAS LEFT UNTREATED. NO DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574574 ↗
• MalfunctionDec 11, 2024Device Slipped; Device Dislodged or Dislocated; Device Slipped; Device Dislodged or Dislocated

  INITIAL PLACEMENT OF THE FIRST MINIMA STENT WAS DEPLOYED DISTAL FROM THE INTENDED DEPLOYMENT LOCATION PREVENTING THE COARCTATION FROM BEING TREATED. AN ATTEMPT TO TELESCOPE A SECOND STENT WITHIN THE FIRST STENT WAS INTENDED TO SIMULTANEOUSLY TREAT THE COARCTATION AND SECURE THE FIRST STENT IN PLACE; HOWEVER, THE SECOND STENT WAS ALSO PLACED DISTAL TO THE INTENDED LOCATION, RESULTING IN NEITHER STENT TREATING THE COARCTATION. A THIRD STENT WAS USED TO SUCCESSFULLY TREAT THE COARCTATION WITHOUT INCIDENT. AFTER COMPLETION OF THE PROCEDURE, THE TELESCOPED STENTS WERE OBSERVED TO MIGRATE DISTALLY AS A RESULT OF NOT BEING SECURED WITHIN A STENOTIC LESION. THE DAY AFTER THE PROCEDURE, X-RAYS CONFIRMED THE TELESCOPED STENTS FIXATED IN A SMALLER DIAMETER VESSEL. FOLLOWING THE IMPLANT PROCEDURE, AN UNRELATED TRANSCATHETER PROCEDURE WAS PERFORMED. DURING WHICH, THE TELESCOPED STENTS WERE RE-DILATED AS A PRECAUTIONARY MEASURE. DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20908816 ↗