Innova™ Vascular H74939293061830Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729874058), received between Feb 10, 2017 and Dec 8, 2017 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (P140028); they may or may not involve this specific model.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2017Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  SAME PATIENT AS MDR ID # 2134265-2017-12021. IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT AND STENT DAMAGE OCCURED. (B)(6) 2017, THE PATIENT PRESENTED WITH INTERMITTENT CLAUDICATION. DURING A LOWER EXTREMITY ANGIOGRAPHY IT WAS OBSERVED THAT A 6 X 180 X 130 INNOVA¿ STENT THAT WAS IMPLANTED IN (B)(6) 2017 HAD OCCLUDED. IT WAS ALSO CONFIRMED THAT THE INNOVA¿ STENT HAD FRACTURED, IN WHICH IT SEEMS TO BE DETACHED AT 3 POINTS. NO TREATMENT HAS BEEN PERFORMED; HOWEVER AN ENDOVASCULAR TREATMENT (EVT) IS SCHEDULED NEXT MONTH. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. WHEN THE ANGIOGRAPHY FROM THE IMPLANT PROCEDURE IN MARCH 2017 WAS REVIEWED, IT SEEMED THE STENT WAS DEPLOYED BY PULLING BACK ON THE INNOVA DELIVERY SYSTEM. THE PHYSICIAN STATED THE STENT STRETCHED AS A RESULT. THE TARGET LESION WAS 100% STENOSED AND WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A CONTRALATERAL APPROACH WAS ACHIEVED TO REACH THE LESION AND PRE-DILATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7101471 ↗
• InjuryDec 8, 2017Fracture; Occlusion Within Device; Fracture; Occlusion Within Device

  SAME PATIENT AS MDR ID # 2134265-2017-12568. IT WAS REPORTED THAT POST THE STENT IMPLANT PROCEDURE THAT THE PATIENT EXPERIENCED INTERMITTENT CLAUDICATION AND IN-STENT RESTENOSIS AND A STENT FRACTURE WERE NOTED. (B)(6) 2017, THE PATIENT PRESENTED WITH INTERMITTENT CLAUDICATION. DURING A LOWER EXTREMITY ANGIOGRAPHY IT WAS OBSERVED THAT A 6 X 180 X 130 INNOVA¿ STENT THAT WAS IMPLANTED IN (B)(6) 2017 HAD OCCLUDED. IT WAS ALSO CONFIRMED THAT THE INNOVA¿ STENT HAD FRACTURED, IN WHICH IT SEEMS TO BE DETACHED AT 3 POINTS. NO TREATMENT HAS BEEN PERFORMED; HOWEVER AN ENDOVASCULAR TREATMENT (EVT) IS SCHEDULED NEXT MONTH. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. WHEN THE ANGIOGRAPHY FROM THE IMPLANT PROCEDURE IN (B)(6) 2017 WAS REVIEWED, IT SEEMED THE STENT WAS DEPLOYED BY PULLING BACK ON THE INNOVA DELIVERY SYSTEM. THE PHYSICIAN STATED THE STENT STRETCHED AS A RESULT. THE TARGET LESION WAS 100% STENOSED AND WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A CONTRALATERAL APPROACH WAS ACHIEVED TO REACH THE LESION AND PRE-DILATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: Claudication; Reocclusion

  MAUDE report 7101322 ↗
• MalfunctionDec 7, 2017Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT AND STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. VASCULAR ACCESS WAS GAINED VIA THE LEFT BRACHIAL ARTERY. A 6F 90CM NON BSC INTRODUCER SHEATH WAS ADVANCED AND BALLOON ANGIOPLASTY WAS PERFORMED WITH A 4MM NON BSC BALLOON CATHETER. THE INNOVA¿ 6X180X130 STENT WAS THEN ADVANCED OVER A .014¿ 300CM NON BSC GUIDEWIRE. DEPLOYMENT OF THE INNOVA¿ WAS INITIATED VIA THE THUMBWHEEL AND THE PULLGRIP WAS PULLED TO DEPLOY THE REMAINDER OF THE STENT. IT WAS NOTED THAT ABOUT 3CM OF THE STENT REMAINED WITHIN THE SHEATH. THE STENT DELIVERY SYSTEM WAS THEN REMOVED RESULTING IN STRETCHING THE PROXIMAL SIDE OF THE STENT ABOUT 4-5CM. BLOOD FLOW WAS SECURED, NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE CONCLUDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7095517 ↗
• MalfunctionNov 7, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED. THE 100% STENOSED, CHRONIC TOTAL OCCLUDED (CTO) TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS CROSSED SUBINTIMAL WITH SEVERE CALCIFICATION. PRE-DILATATION WAS PERFORMED USING A 6MM MUSTANG BALLOON CATHETER, BUT IT HAD DIFFICULTY IN CROSSING DUE TO SEVERE RECOIL AND THE ANGLE OF THE ILIAC WAS STEEP. THE 6X180X130 INNOVA WAS ADVANCED CONTRALATERAL OVER A NON-BSC .035¿ GUIDEWIRE AND STENT DEPLOYMENT WAS INITIATED. APPROXIMATELY MID-DEPLOYMENT, A SOUND WAS HEARD INSIDE THE HANDLE LIKE SOMETHING BROKE, AND FURTHER DEPLOYMENT WAS NOT POSSIBLE. THE PHYSICIAN DISASSEMBLED THE HANDLE DUE TO THE SUSPECTED DAMAGE AND RELEASED THE STENT USING THE PIN AND PULL METHOD. THE STENT WAS DEPLOYED SUCCESSFULLY AND POST-DILATED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7007143 ↗
• MalfunctionAug 22, 2017Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED AND THE STENT STRETCHED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A .014 NON BSC GUIDEWIRE WAS ADVANCED AND THE LESION WAS PRE-DILATED WITH A 5MM STERLING BALLOON. A 6X100 INNOVA¿ STENT WAS ADVANCED CONTRALATERAL OVER THE GUIDEWIRE AND IMPLANTED. A 6X180X130 INNOVA¿ STENT WAS THEN ADVANCED TO TREAT THE PERIPHERAL SIDE. THE PHYSICIAN FELT RESISTANCE WITH THE SHAFT DURING ADVANCEMENT AND EVENTUALLY THE 6X180X130 INNOVA¿ STENT CROSSED THE LESION AND DEPLOYMENT WAS INITIATED VIA THE THUMBWHEEL. THE DEPLOYMENT HANDLE¿S THUMBWHEEL WAS ROTATED FULLY AND THE PULL GRIP WAS PULLED, HOWEVER ONLY 18CM OF THE STENT WAS DEPLOYED. THE PHYSICIAN THEN PULLED THE ENTIRE CATHETER SYSTEM AND THEN THE REMAINDER OF THE STENT DEPLOYED; HOWEVER, IT WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6812339 ↗
• MalfunctionJun 27, 2017Kinked; Kinked

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. AN INNOVA¿ STENT WAS SELECTED FOR A PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS ANATOMY WITH 100% STENOSIS AND THE LESION WAS SEVERELY CALCIFIED. CONTRALATERAL APPROACH WAS PERFORMED IN THE SFA. PRE DILATION WAS PERFORMED USING A MUSTANG BALLOON. AFTER APPROACHING THE ILIAC FROM THE OPPOSITE SIDE, THE SHEATH BOUNCED AT THE APPROACHED PART INTO THE AORTA WHEN TRYING TO DELIVER THE INNOVA¿. THE STENT WAS KINKED AND THE DEVICE WAS RETRIEVED AT THIS TIME. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6670946 ↗
• MalfunctionMay 22, 2017Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATION WAS PERFORMED WITH AN UNKNOWN 4MMX22CM BALLOON CATHETER. A CONTRALATERAL APPROACHED WAS USED TO INTRODUCE THE 6 X180X130MM INNOVA¿ STENT AND DEPLOYMENT WAS INITIATED VIA THE THUMBWHEEL. 12CM OF THE INNOVA¿ WAS DEPLOYED THEN THE PULL GRIP WAS ATTEMPTED TO BE PULLED TO DEPLOY THE REMAINDER OF THE STENT. THE PULL GRIP MALFUNCTIONED AND THE REMAINDER OF THE STENT DID NOT DEPLOY. THE PHYSICIAN ATTEMPTED TO USE THE PULL GRIP OVER AND OVER AGAIN AND EACH TIME THE INNOVA¿ STENT DEPLOYED LITTLE BY LITTLE UNTIL THE STENT FULLY DEPLOYED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6582529 ↗
• MalfunctionApr 6, 2017Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED AND DAMAGED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). THE INNOVA¿ WAS INTRODUCED VIA A CONTRALATERAL APPROACH. THE LESION WAS CROSSED USING NON-BSC GUIDEWIRE AND THE 6 X 180 X 130 INNOVA¿ WAS THEN ADVANCED ALONG THE GUIDEWIRE FROM THE OPPOSITE SIDE TO THE SAME SIDE OF THE LESION. THE INNOVA¿ WAS THEN WAS ADVANCED TO THE TARGET LESION AND PLACEMENT WAS ATTEMPTED. DEPLOYMENT WAS SUCCESSFULLY INITIATED AND DEPLOYED ABOUT 5CM THEN THE THUMBWHEEL STOPPED WORKING AND DEPLOYMENT STOPPED. THE PHYSICIAN TRIED TO DEPLOY THE STENT WITH THE PULL GRIP, HOWEVER RESISTANCE WAS ENCOUNTERED AND 10CM OF THE STENT WAS DEPLOYED. THE ENTIRE SYSTEM WAS THEN PULLED, AND ALL OF THE STENT WAS DEPLOYED SUCCESSFULLY. THE STENT WAS THEN CHECKED UNDER FLUOROSCOPY AND THE STRUT APPEARED DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6463180 ↗
• MalfunctionMar 1, 2017Entrapment of Device; Activation, Positioning or Separation Problem; Entrapment of Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DEPLOYMENT DIFFICULTIES AND CATHETER ENTRAPMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A CONTRALATERAL APPROACH USING A 6F INTRODUCER SHEATH. THE CHRONICALLY TOTAL OCCLUDED 30 CM TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). INTRAVASCULAR ULTRASOUND (IVUS) WAS USED AND A NON-BSC GUIDEWIRE WAS CROSSED TO THE LESION. THEN THE GUIDEWIRE WAS EXCHANGED TO ANOTHER NON-BSC GUIDEWIRE FOR STRONGER SUPPORT. AFTER PREDILATION WITH A 4 MM BALLOON CATHETER, A 6 MM-180 MM/130 CM INNOVA¿ STENT WAS ADVANCED TO THE DISTAL SFA. WHILE ATTEMPTING TO RELEASE THE STENT, THE RESPONSE OF THE THUMBWHEEL WAS NOT GOOD AND THE DIAL OF THE THUMBWHEEL STOPPED WITHOUT REACHING IN 12 CM. THE WHITE ARROW WAS OBSERVED. THEN THE PULL GRIP WAS PULLED TO DEPLOY THE STENT, BUT IT STOPPED DEPLOYING ABOUT THE REMAINING 3 CM OF THE STENT. FINALLY THE STENT WAS DEPLOYED BY PULLING THE WHOLE DELIVERY SYSTEM. UPON WITHDRAWAL, THE STENT DELIVERY SYSTEM GOT STUCK ON THE GUIDEWIRE. AFTER SEVERAL ATTEMPTS, THE DEVICE WAS PULLED OUT WITH THE GUIDEWIRE TOGETHER. THEN THE GUIDEWIRE WAS CROSSED AGAIN TO THE LESION AND A NON-BSC STENT WAS PLA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370163 ↗
• InjuryFeb 10, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT SHORTENING OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA A CONTRALATERAL APPROACH. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6 MM - 180 MM/130 CM INNOVA STENT WAS ADVANCED TO THE TARGET LESION AND DEPLOYED. HOWEVER, STENT SHORTENING OCCURRED, THUS ANOTHER 6 MM - 100 MM/130 CM INNOVA STENT WAS PLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6323518 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140028. One submission often covers many models, so check the product and lot details in each record.

• Z-0685-2018 · Nov 6, 2017 · Open, Classified
  Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated t
• Z-0686-2018 · Nov 6, 2017 · Open, Classified
  Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated