OPTIS™ 1014933Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067037145), received between Apr 6, 2023 and May 17, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2023Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE OPTIS NEXT SYSTEM WAS USED AND A RUN WAS PERFORMED WITHOUT ANY ERROR MESSAGES OR PHYSICAL ISSUES; HOWEVER, UPON ASSESSING THE IMAGE IT WAS NOTED THE AI STENT LANDING ZONE MARKERS WERE NOT IN THE RIGHT POSITION ON THE VESSEL. ADDITIONALLY, THE LENGTH OF THE AREA OF CONCERN WAS NOT CORRECT. THE OPTICAL COHERENCE TOMOGRAPHY (OCT) MEASURED A LENGTH OF 13.4MM LONG; THEREFORE THE DECISION WAS MADE TO USE AN 18MM LONG STENT. WHEN THE STENT WAS INSERTED, IT WAS FOUND TO BE TOO SHORT; THEREFORE IT WAS REMOVED BEFORE DEPLOYMENT AND A 23MM LONG STENT WAS IMPLANTED SUCCESSFULLY INSTEAD. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947326 ↗
• MalfunctionMay 16, 2023Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings; Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE OPTICAL COHERENCE TOMOGRAPHY (OCT) ASSESSMENT OF THE LESION, THE OPTIS NEXT INTEGRATED SYSTEM SHOWED A STENT OF 15MM LONG WAS NEEDED TO TREAT THE LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). WHEN THE STENT SYSTEM WAS ADVANCED TO THE LESION, IT WAS NOTED THAT THE STENT WOULD BE TOO SHORT FOR THE LESION; THEREFORE, THE STENT SYSTEM WAS REMOVED, UNDEPLOYED. AN 18MM STENT SYSTEM WAS THEN ADVANCED TO THE LESION AND USED WITHOUT ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943127 ↗
• MalfunctionApr 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE MILDLY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. AN ASSESSMENT OF THE LESION WAS PERFORMED WITH THE OPTIS NEXT ULTREON SYSTEM TO MEASURE THE LESION FOR STENTING. THE PHYSICIAN USED A COMBINATION OF THE OCT IMAGE AND THE CO-REGISTRATION IMAGE TO DECIDE THE LENGTH OF THE STENT; THE TIP OF THE GUIDE CATHETER WAS PLACED JUST PAST THE DISTAL MARKER OF THE IMAGING CATHETER DURING CO-REGISTRATION. THE ASSESSMENT DETERMINED THAT A 23MM LENGTH STENT WAS LONG ENOUGH TO COVER THE AREA OF CONCERN. A 3.0X23MM XIENCE SKYPOINT STENT WAS ADVANCED AND DEPLOYED WITHOUT ISSUES; HOWEVER, THE STENT WAS TOO SHORT FOR THE LESION. A SECOND STENT WAS IMPLANTED TO COVER THE TARGET LESION. PER THE PHYSICIAN, IMAGING SUGGESTED THE WRONG LENGTH STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16694626 ↗