WALLSTENT™ RP Endoprosthesis M001712180Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729345749), received between Sep 11, 2017 and Jun 11, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PROFILE PROBLEM OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A SHUNT IN THE MODERATELY TORTUOUS, MILDLY CALCIFIED, AND 7 MM IN DIAMETER BRACHIAL VEIN. AN 8X38X75/ ILIAC 6F WALLSTENT¿ RP ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTED DURING DEPLOYMENT THAT THE LENGTH OF THE STENT WAS ABOUT 1 CM. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL WALLSTENT PLACED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7588185 ↗
• MalfunctionJun 7, 2018Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT STENT RECONSTRAINMENT FAILURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VEIN IN THE UPPER ARM. AN 8X38X75/ ILIAC 6F WALLSTENT¿ RP ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING DEPLOYMENT, IT WAS NOTED THAT THE STENT DID NOT FULLY DEPLOY AND WAS STILL ATTACHED TO THE CATHETER. WHEN THE DEVICE WAS REMOVED, THE STENT WAS NOT CONSTRAINED. THE STENT AND CATHETER WERE COMPLETELY REMOVED OUTSIDE THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7577828 ↗
• MalfunctionSep 11, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PROFILE PROBLEM OCCURRED. THE STENOSED, 2CM TARGET LESION WAS LOCATED IN THE LEFT ILIAC ARTERY. AN 8X38X75 WALLSTENT RP ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE STENT WAS DEPLOYED, IT WAS NOTICED THAT THE STENT SIZE WAS ACTUALLY LONGER THAN THE SIZE STATED ON THE BOX. THE DEPLOYED STENT WAS APPROXIMATELY MORE THAN 80MM. THE PROXIMAL PORTION OF THE STENT WAS PLACED AT THE ORIFICE OF THE LEFT ILIAC ARTERY AND AT 38MM, IT SHOULD NOT HAVE EXTENDED BELOW THE INTERNAL ILIAC ARTERY BIFURCATION. THE DEPLOYED STENT EXTENDED IN THE EXTERNAL ILIAC ARTERY. NO ADDITIONAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION WAS REPORTED TO BE GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6855848 ↗