ViperWire, Advance VPR-GW-17Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10852528005084), received between Nov 21, 2018 and Nov 15, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jun 13, 2016Class IITerminated

   The pouch label was missing the use by date (UBD) of 2018-04.

   Z-2051-2016 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A 90% CALCIFIED LEFT COMMON FEMORAL ARTERY AND 50%-70% DIFFUSED SUPERFICIAL FEMORAL ARTERY USING AN EMBOSHIELD NAV 6 FILTER WITH A 6F SHEATH AND A VIPERWIRE ADVANCE GUIDEWIRE. THE NAV 6 FILTER CROSSED THE TARGET LESION, HOWEVER WHEN RETRIEVING THE DEVICE, THE TIP OF THE GUIDEWIRE BROKE OFF INTO TWO PIECES AND THE GUIDEWIRE ABOUT 1 CM IN LENGTH REMAINED IN THE PATIENT. THE WIRE TIP WAS EMBEDDED IN A BRANCH POST PROCEDURE. THE EMBOSHIELD NAV 6 FILTER WAS REMOVED WITH THE SHEATH AND IN THE PHYSICIAN'S OPINION, THE PATIENT WILL NEED ADDITIONAL INTERVENTION TO RETRIEVE THE GUIDE WIRE TIP AND DOES NOT HAVE ANY CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUTCOMES. MANUAL COMPRESSION WAS HELD AFTER REMOVAL OF SHEATH WITH NAV 6 FILTER AND WIRE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 20698710 ↗
• InjuryNov 8, 2024Material Separation; Improper or Incorrect Procedure or Method; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED A VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WAS USED FOR TREATMENT OF CALCIFIED LESION IN SUPERFICIAL FEMORAL ARTERY (SFA). THE ABBOTT EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM WAS POSITIONED IN POPLITEAL AND USED WITH THE VIPERWIRE. FOLLOWING FIVE CSI ATHERECTOMY TREATMENTS, THE TIP OF THE VIPERWIRE FRACTURED UPON RETRIEVAL OF THE NAV6 FILTER. THE VIPERWIRE TIP WAS SUCCESSFULLY SNARED. THE PATIENT WAS STABLE AND DISCHARGED HOME WITHOUT FURTHER COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642209 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORBITAL ATHERECTOMY TREATMENT WAS SELECTED FOR A 30 MM LESION IN THE SUPERFICIAL FEMORAL ARTERY. FOLLOWING OA, BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED. AFTER STENT PLACEMENT THE (B)(6) FILTER AND GUIDE WIRE WERE ADVANCED TO THE VESSEL AND THE GUIDE WIRE DISSECTED THE ARTERY. A THROMBUS WAS OBSERVED IN THE ANTERIOR TIBIAL SEGMENT OF THE FOOT WHERE THE DISTAL END OF THE GUIDE WIRE HAD BEEN LOCATED. A PENUMBRA DEVICE WAS USED TO RETRIEVE THE THROMBUS AND THE PATIENT WAS DISCHARGED THE FOLLOWING MORNING WITHOUT ISSUE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11859884 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE VIPERWIRE GUIDE WIRE WAS POSITIONED WITH THE TIP IN THE TIBIOPERONEAL TRUNK DURING TREATMENT OF A LESION IN THE SUPERIOR FEMORAL ARTERY; THE PLACEMENT WAS DISTAL TO ALLOW FOR USE OF A NON-CSI FILTER. A SMALL PERFORATION IN THE PERONEAL ARTERY WAS SEEN ON IMAGING FOLLOWING SUCCESSFUL TREATMENT OF THE LESION AND SUBSEQUENT FILTER RETRIEVAL. THE PHYSICIAN DETERMINED THAT NO TREATMENT WAS NECESSARY FOR THE PERFORATION DUE TO ITS SMALL SIZE. THE PROCEDURE WAS COMPLETED, AND COMPRESSION WAS NOT APPLIED TO THE AREA. LATER IN THE SAME DAY, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY DUE TO COMPARTMENT SYNDROME IN THE LOWER EXTREMITY. AS OF 7 APRIL 2021, THE PATIENT WAS WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation of Vessels

  MAUDE report 11699865 ↗
• InjuryApr 20, 2021Material Separation; Material Separation

  THE VIPERWIRE GUIDE WIRE FRACTURED DURING TREATMENT OF THE ANTERIOR TIBIAL AND DISTAL SUPERFICIAL FEMORAL ARTERIES, WHICH WERE SEVERELY CALCIFIED. THE FRACTURE OCCURRED WHEN THE USER ATTEMPTED TO ADVANCE THE ATHERECTOMY DEVICE THROUGH A LESION. THE TREATMENTS HAD ALL BEEN BETWEEN 30 AND 45 SECONDS. THE FRAGMENT WAS SNARED, AND THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY AND STENT PLACEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11692173 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE WAS PLANNED. THE TARGET LESION WAS AN 85% STENOSED, MODERATELY TO SEVERELY CALCIFIED LESION THAT WAS LOCATED IN THE TIBIOPERONEAL TRUNK. THE LESION WAS 100MM IN LENGTH AND LOCATED IN A 4MM DIAMETER SECTION OF THE ARTERY. THE LESION WAS WIRED WITH A NON-CSI GUIDE WIRE, BUT ACCESS WAS LOST. AFTER REWIRING THE LESION WITH A VIPERWIRE GUIDE WIRE, A TYPE C DISSECTION WAS NOTED. A DECISION WAS MADE TO NOT CONTINUE WITH ORBITAL ATHERECTOMY, AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED TO RESOLVE THE DISSECTION. THE PROCEDURE WAS COMPLETED WITH PTA AND A STENT. THE PATIENT'S STATUS WAS GOOD FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 8557754 ↗
• MalfunctionNov 21, 2018Entrapment of Device; Entrapment of Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE TIP OF THE VIPERWIRE GUIDE WIRE BECAME STUCK IN A NON-CSI FILTER, RESULTING IN A PROCEDURAL DELAY. THE TARGET LESIONS WERE 99% STENOSED AND LOCATED IN THE PROXIMAL AND MID SUPERFICIAL FEMORAL ARTERY. A NON-CSI FILTER WAS BEING UTILIZED OVER THE CSI GUIDE WIRE. DURING REMOVAL OF THE FILTER FOLLOWING ATHERECTOMY TREATMENT, THE GUIDE WIRE BECAME STUCK IN THE BASKET OF THE FILTER. THE FILTER WAS THEN DIFFICULT TO REMOVE AND WIRE ACCESS WAS LOST, LEADING TO A PROCEDURAL DELAY GREATER THAN 30 MINUTES. THE LESION WAS RE-WIRED AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8095866 ↗