Visi-Pro™ PXB35-06-17-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169787667), received between Sep 8, 2021 and Nov 18, 2024 — classified as 1 death, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2024Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  A PHYSICIAN WAS ATTEMPTING TO IMPLANT A VISIPRO STENT FOR TREATMENT OF A 20 MM PLAQUE LESION IN THE PROXIMAL REGION OF THE RIGHT RENAL ARTERY. THE ARTERY WAS 6 MM IN DIAMETER WITH MINIMAL CALCIFICATION AND NO TORTUOSITY. A 6FR TOURGUIDE SHEATH WAS USED WITH A NON-MEDTRONIC SHEATH. A 3 MM NANOCROSS WAS USED FOR PRE-DILATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS MET DURING ADVANCEMENT OF THE DEVICE. THE IFU WAS FOLLOWED. THE LOCK PIN WAS CHECKED FOR SECUREMENT PRIOR TO THE PROCEDURE. IT WAS REPORTED THE STENT CAME OFF THE BALLOON IN THE PATIENT PRIOR TO INFLATION. IT CAME OFF AN PRE-DEPLOYED OUTSIDE THE TARGET LESION AREA. THE STENT REMAINS IN THE PATIENT. NO DEFORMATION NOTED TO THE DEPLOYED STENT. THE DELIVERY SYSTEM WAS SAFELY REMOVED. NO INJURY OR INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL STENTING WAS CARRIED OUT. NO VESSEL DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706457 ↗
• MalfunctionAug 10, 2023Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  PHYSICIAN ATTEMPTED TO IMPLANT A VISIPRO BALLOON EXPANDABLE STENTS DURING TREATMENT OF A LESION IN THE PATIENTS RENAL ARTERY. MODERATE VESSEL TORTUOSITY IS REPORTED. EMBOLIC PROTECTION WAS NOT USED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. IT IS REPORTED STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THIS ISSUE IS REPORTED FOR 2 VISIPRO BALLOON EXPANDABLE STENTS. PHYSICIAN DEPLOYED ONE DISLODGED STENT IN THE ILIAC ARTERY, BUT WAS SUPPOSED TO BE DEPLOYED IN RENAL ARTERY. PHYSICIAN RETRIEVED THE OTHER DISLODGED STENT WITHIN THE SHEATH. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498549 ↗
• DeathApr 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A VISI PRO BALLOON EXPANDABLE STENT WAS BEING USED DURING THE TREATMENT OF A 12MM CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL REGION OF THE CELIAC ARTERY. THE ARTERY WAS 5MM IN DIAMETER WITH MILD TORTUOSITY AND MODERATE CALCIFICATION. A 6FR SHEATH AND A 0.035 GUIDEWIRE WERE USED. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FORM THE PACKAGING. THE PATIENT HAD A PREVIOUSLY IMPLANTED SMA ICAST STENT THAT WAS OCCLUDED VIA CT SCAN, SHE ALSO HAD A 80% CELIAC STENOSIS. THE PLAN WAS TO TRY TO OPEN UP THE SMA STENT AND STENT THE CELIAC. DURING THE PROCEDURE THEY WERE ABLE TO CANNULATE THE SMA BUT NOT ABLE TO CROSS THE OCCLUSION. THEN MOVED ON TO THE CELIAC, WHICH COULD NOT BE CROSSED. THE VISI PRO STENT WAS DELIVERED THROUGH THE TOUR GUIDE TO THE STENOSIS. WHILE PULLING THE STENT BACK TO THE INTENDED DELIVERY SITE, THE STENT BECAME DISLODGED OFF THE BALLOON. THE BALLOON WAS TAKEN OUT OF THE PATIENT AND AN ATTEMPT WAS MADE TO SNARE THE STENT. THE SNARE DID NOT WORK AND A NAVICROSS WAS USED TO GO THROUGH THE STENT AND EXCHANGE FOR AN .014 WIRE. A .014 BALLOON WAS

  Patient problems: Asystole

  MAUDE report 16662603 ↗
• MalfunctionSep 1, 2022Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO BALLOON EXPANDABLE STENT ALONG WITH A NON-MEDTRONIC 6FR SHEATH DURING PROCEDURE TO TREAT TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL RENAL ARTERY. THE VESSEL DIAMETER AND LESION LENGTH WERE 6MM AND 15MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT DURING DELIVERY TO/AT LESION SITE, STENT DISLODGEMENT OCCURRED. PHYSICIAN STATES HE HAD SHEATH CLOSE TO RENAL ARTERY TRIED TO PASS THEN LOOKED UP AND STENT WAS ON WIRE THEN OFF AND SLIDE DOWN TO HYPOGASTRIC ARTERY. STENT SETTLED IN HYPOGASTRIC ARTERY WHICH WAS MEANT FOR RENAL ARTERY. THE DISLODGED STENT WAS NOT REMOVED AND NO INTERVENTION WAS PERFORMED. STENT WAS IN HYPOGASTRIC AND THEN PHYSICIAN CLOSED IN GROIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335520 ↗
• MalfunctionMay 30, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  A PHYSICIAN ATTEMPTED TO USE A VISIPRO BALLOON EXPANDABLE STENT SYSTEM DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT'S PROXIMAL SUPERIOR MESENTERIC ARTERY (SMA). MODERATE VESSEL CALCIFICATION AND SEVERE TORTUOSITY ARE REPORTED. THERE WAS NO DAMAGE NOTED TO PACKAGING (I.E. SHELF CARTON, HOOP/TRAY). THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. PRE-DILATION WAS PERFORMED WITH A 5MM BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT BUT NO EXCESSIVE FORCE WAS USED. STENT DISLODGEMENT IS REPORTED. THE STENT CAME OFF BALLOON AS IT WAS BEING REMOVED THROUGH THE SHEATH AFTER IT WAS NOT ABLE TO BE ADVANCED THROUGH THE LESION. SHEATH WAS REMOVED AND STENT WAS RETRIEVED OUT OF THE SHEATH AFTER IT WAS OUT OF THE BODY. NO DEFORMATION NOTED TO THE DEPLOYED STENT. SHEATH WAS PLACED BACK IN THE PATIENT AFTER STENT WAS REMOVED. BALLOONS WERE USED TO PRE-DILATE THE LESION. A LARGER 6MM PTA WAS USED TO PRE DILATE AND THEN ANOTHER VISIPRO STENT TRACKED THROUGH THE LESION AND WAS DEPLOYED SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14540239 ↗
• MalfunctionMay 4, 2022Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE A VISI PRO BALLOON EXPANDABLE STENT ALONG WITH A NON-MEDTRONIC 6FR SHEATH DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT BILIARY ARTERY AND COMMON ILIAC ARTERY. THE VESSEL WAS LITTLE TORTUOUS. NO EMBOLIC PROTECTION USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICES FROM HOOP/TRAY. THE DEVICES WERE PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE FIRST VISI PRO WAS INACCURATELY DELIVERED (THAT IS, STENT DEPLOYED IN UNINTENDED LESION SITE). THERE WAS SUFFICIENT LANDING ZONE. THE STENT WAS FULLY EXPANDED. IT CAME OFF THE BALLOON AT THE EXTERNAL ILIAC EN ROUTE TO THE RENAL ARTERY. IT WAS THEN DEPLOYED IN THIS POSITION. THERE WAS AN ATTEMPT MADE TO REMOVE THE STENT. IT IS UNKNOWN IF THERE WAS DEFORMATION NOTED ON THE STENT. THE LESION WAS NOT PRE DILATED. THE FIRST DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE USED. ANOTHER STENT WAS SELECTED, PXB35-07-17-080, DELIVERED TO TARGET LESION AND DEPLOYED. THE SECOND VISI PRO, BALLOON DEFLATION DIFFICULTIES OCCURRED WITH THE DEVICE SLOW TO DEFLATE AT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14276349 ↗
• MalfunctionSep 8, 2021Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  PHYSICIAN WAS ATTEMPTING TO USE VISI PRO BALLOON EXPANDABLE STENT ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.035" GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE PROXIMAL RENAL ARTERY. THE VESSEL WAS MODERATELY TORTUOUS. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING REMOVAL FOLLOWING FAILED DELIVERY, STENT DISLODGEMENT OCCURRED. THE STENT DISLODGED IN THE SHEATH AFTER UNSUCCESSFUL DELIVERY, THE STENT IS STILL INSIDE THE SHEATH AND WILL BE RETURNED THAT WAY. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS CARRIED OUT WITH A NEW SHEATH AND STENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE WITH NO EXCESSIVE FORCE USED. THE BALLOON CATHETER WAS REMOVED WITHOUT NOTICE OF THE DISLODGED STENT, PRE DILATION WAS PERFORMED AND WHEN THE PHYSICIAN AND SCRUB WENT TO REINSERT THESTENT THEY NOTICED THAT IT WAS NO LONGER ON THE BALLOON CATHETER. THEY USED FLUOROSCOPY TO LOCATE THE STENT INSIDE OF THE SHEATH RIGHT AT THE HUB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439180 ↗