Evolution G46539Recalls & reported problems
Cook Vandergrift Inc. · Evolution 9 Fr Mechanical Dilator Sheath Set · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002465395), received between Dec 2, 2025 and Dec 2, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Align” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Align1
- Material Too Rigid or Stiff1
Patient problems
- Cardiac Perforation1
- Low Blood Pressure/ Hypotension1
- Pericardial Effusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2025Material Too Rigid or Stiff; Failure to Align; Adverse Event Without Identified Device or Use Problem; Material Too Rigid or Stiff; Failure to Align; Adverse Event Without Identified Device or Use Problem
AS REPORTED ON THE MEDWATCH FORM: IN ACCORDANCE WITH TITLE 21 PART 803, SUBPART B, 803.22(B)(2), THIS LETTER IS TO NOTIFY AND PROVIDE YOU THE INFORMATION PHILIPS RECEIVED ON (B)(6) 2025 WHICH REPORTED THAT DURING A LEAD EXTRACTION PROCEDURE, A PERICARDIAI EFFUSION WAS OBSERVED, AND THORACOTOMY WAS PERFORMED TO REPAIR A CORONARY SINUS PERFORATION. THE PATIENT SURVIVED THE PROCEDURE. A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE RA, RV, AND LV LEADS DUE TO CIED SYSTEM/POCKET INFECTION. THE RA AND RV LEADS WERE PREPPED WITH LLDS AND THE LV LEAD WAS PREPPED WITH SUTURE AND STEEL WIRE TO PROVIDE TRACTION. THE RA AND RV LEADS WERE REMOVED SUCCESSFULLY. USING A SPECTRANETICS 12F GLIDELIGHT ADVANCEMENT COULD NOT BE MADE OVER THE CALCIFIED SUBCLAVIAN REGION. SWITCHING TO A (B)(6)8. SF BYRD DILATOR SHEATH, PROGRESS WAS MADE TO THE RA. NEXT, THE GLIDELIGHT COULD ADVANCE WITHOUT RADIATION TO RA, AND THE LV LEAD BROKE. CHANGING TO A (B) (6) 9F EVOLUTION, AND ALIGNING AXIS TO THE CORONARY SINUS, THE LEAD SEPARATED. AFTER THAT, SWITCHING TO A FEMORAL APPROACH AND RIGHT SUBCLAVIAN APPROACH, A 14F GLIDELIGHT AND OSPIKA SNARE WAS USED TO GRASP THE CONDUCTOR WIRE. THE GLIDELIGHT WAS ADVANCED WITHOU
Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion
MAUDE report 23697631 ↗
Other DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION devices
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization3 deaths108 reports
- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Mini Stick MAX H965457490Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.