Innova™ Vascular H74939293062030Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 08714729874065), received between Nov 15, 2016 and Jul 8, 2025 — classified as 18 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (27 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED PERIPHERAL ARTERY. A 6 X 200 X 130 INNOVA? VASCULAR STENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS DEPLOYED BY ABOUT 1MM BUT COULD NOT BE FULLY DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER INNOVA STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437236 ↗
• MalfunctionJun 23, 2025Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED, AND THE STENT STRETCHED. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE CHRONIC TOTAL OCCLUSION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6 X 200 X 130 INNOVA VASCULAR STENT WAS ADVANCED FOR PERIPHERAL ARTERY DISEASE TREATMENT. DURING THE PROCEDURE, THIS STENT WAS DIFFICULT TO DEPLOY; ONLY 6CM DEPLOYED WHEN IT WOULD NO LONGER DEPLOY ALL THE WAY, EVEN WHEN THE PULL GRIP WAS UTILIZED. SUBSEQUENTLY, THE HANDLE WAS TAKEN APART IN ORDER TO COMPLETE STENT DEPLOYMENT. HOWEVER, AS A RESULT OF THIS EVENT, THE STENT STRETCHED APPROXIMATELY 100 MM. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310251 ↗
• InjuryNov 9, 2023Fracture; Failure to Advance; Activation, Positioning or Separation Problem; Fracture; Failure to Advance; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED AND SUBSEQUENTLY FRACTURED UPON REMOVAL, REQUIRING AN ADDITIONAL DEVICE. THIS 6 X 200 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR USE IN A PERIPHERAL ANGIOGRAM WITH INTERVENTION PROCEDURE. ACCESS WAS OBTAINED CONTRALATERALLY AND THE 100% STENOSED, SEVERELY CALCIFIED, MILDLY TORTUOUS SUPERFICIAL FEMORAL ARTERY LESION WAS CROSSED; HOWEVER, A GOOD MAJORITY OF THE VESSEL WAS CROSSED SUBINTIMALLY, AS VISUALIZED VIA INTRAVASCULAR ULTRASOUND (IVUS). THE CHRONIC TOTAL OCCLUSION WAS PREDILATED WITH A NON-BOSTON SCIENTIFIC LASER AND SEQUENTIAL BALLOON TREATMENT, RESULTING IN 75 TO 80% OCCLUSION AFTER PREDILATION. ON THE FIRST ATTEMPT, THE PHYSICIAN TRIED TO LOAD THIS INNOVA VASCULAR STENT OVER A V-18 WIRE BUT THAT DID NOT CROSS. THEY THEN TRANSITIONED TO A MAGIC TORQUE WIRE AND ATTEMPTED TO LOAD THE STENT AGAIN. THE STENT CROSSED WITH GREAT DIFFICULTY; THE PHYSICIAN HAD TO PUSH QUITE A BIT TO GET IT THROUGH. WHILE DEPLOYING THE STENT WITH THE WHEEL MECHANISM, AFTER APPROXIMATELY 3 TO 5 SECONDS, A HARD CLICK WAS HEARD. AT THAT POINT THE STENT STOPPED DEPLOYING; HOWEVER, ONLY APPROXIMATELY 20 TO 30MM OF THE STENT HAD BEEN DEPLOYED. THE PUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102468 ↗
• MalfunctionOct 10, 2023Entrapment of Device; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Entrapment of Device; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND STRETCHED. A 6 X 200 X 130 INNOVA SELF EXPANDING STENT WAS SELECTED FOR USE IN A STENTING PROCEDURE. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE 90% STENOSED SUPERFICIAL FEMORAL ARTERY THAT WAS SEVERELY CALCIFIED AND SEVERELY TORTUOUS. THE LESION WAS PRE-DILATED WITH A 5 X 220 STERLING BALLOON. DURING DEPLOYMENT OF THE INNOVA DEVICE, THE STENT WOULD NOT FULLY DEPLOY. ELEVATED FORCE WAS REQUIRED TO TURN THE THUMBWHEEL AND THEN IT STOPPED WORKING. ONLY 60% OF THE STENT WAS DEPLOYED. THE PULL GRIP WAS PULLED IN AN ATTEMPT TO DEPLOY THE LAST 100MM. SOME OF THE STENT DEPLOYED, BUT NOT ALL OF IT. THE BLUE HANDLE WAS PULLED HARDER, AND THE STENT EVENTUALLY DEPLOYED BUT ELONGATED. THE STENT STRETCHED APPROXIMATELY 20MM. AFTER IMPLANTING THE STENT, THE DELIVERY SYSTEM BECAME STUCK ON THE 018 NON-BOSTON SCIENTIFIC GUIDEWIRE. THE HANDLE WAS DISASSEMBLED IN ORDER TO PULL IT OFF THE GUIDEWIRE, BUT THIS WAS UNSUCCESSFUL. EXTERNAL TO THE PATIENT, THE PHYSICIAN THEN USED A SCALPEL TO CUT AWAY THE PROXIMAL SECTION OF THE DELIVERY SYSTEM TO EXPOSE THE GUIDEWIRE AND PULL THE DISTAL PART OF THE DELIVERY SYSTEM OFF THE GUIDEWIRE. THE IMPLANTED S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17907391 ↗
• MalfunctionOct 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE STENT FRACTURED. THIS 6 X 200 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY INTERVENTION PROCEDURE. THE 85% STENOSED, MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WAS FIRST TREATED WITH JETSTREAM ATHERECTOMY. THIS INNOVA STENT WAS SUBSEQUENTLY DEPLOYED, AND THEN A SECOND INNOVA STENT WAS DEPLOYED. BOTH STENTS WERE POST DILATED WITH A 5X200 STERLING BALLOON. WHEN DILATING THE FIRST STENT AT APPROXIMATELY 8 ATMOSPHERES IT FRACTURED IN THE MIDDLE. THE STENT REMAINED PATENT, AND THE PHYSICIAN CONTINUED POST DILATING THE REST OF THE STENTED AREA WITHOUT ANY ISSUES. THE STENT FRACTURE WAS VISIBLE VIA X-RAY IMAGES AND WAS NOT FLOW LIMITING. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871341 ↗
• InjuryNov 17, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR 2134265-2017-11104 AND MDR 2134265-2017-11105. IT WAS REPORTED THAT IN STENT RESTENOSIS OCCURRED. ON (B)(6) 2016 THE PATIENT PRESENTED WITH ATHEROSCLEROSIS OF NATIVE ARTERIES OF EXTREMITIES WITH REST PAIN IN THE LEFT LEG AND THE INDEX PROCEDURE WAS PERFORMED. AN ANGIOGRAM OF THE LEFT COMMON FEMORAL ARTERY FOUND THAT THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND LEFT POPLITEAL ARTERY WERE OCCLUDED. FOLLOWING PRE-DILATION, A 6X150 INNOVA STENT WAS PLACED SUCCESSFULLY IN THE LEFT POPLITEAL ARTERY, FOLLOWED BY POST-DILATION. PRE-TREATMENT STENOSIS WAS 50%, POST-TREATMENT STENOSIS WAS 0%. FOLLOWING PRE-DILATION, A 6X150 INNOVA STENT WAS PLACED SUCCESSFULLY IN THE DISTAL LEFT SFA, FOLLOWED BY POST-DILATION. PRE-TREATMENT STENOSIS WAS 50%, POST-TREATMENT STENOSIS WAS 50%. FOLLOWING PRE-DILATION, A 6X120 INNOVA STENT WAS PLACED SUCCESSFULLY IN THE PROXIMAL LEFT SFA, FOLLOWED BY POST-DILATION. PRE-TREATMENT STENOSIS WAS 50%, POST-TREATMENT STENOSIS WAS 0%. THERE WERE EXCELLENT RESULTS IN THE THREE VESSEL RUNOFF AND IMPROVED DOPPLERS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S CONDITION POST PROCEDURE WAS STABLE. ON (B)(6) 2017 THE PATIENT PRESENTED WITH

  Patient problems: Reocclusion

  MAUDE report 7042967 ↗
• MalfunctionNov 7, 2017Entrapment of Device; Entrapment of Device

  SAME CASE AS: 2134265-2017-10684. IT WAS REPORTED THE STENT DELIVERY SYSTEM BECAME ENTRAPPED ON THE GUIDEWIRE. A 6 X 200 X 130 INNOVA¿ STENT AND 035/260 MAGIC TORQUE¿ GUIDEWIRE WERE SELECTED FOR A PROCEDURE IN THE AORTA. AFTER THE STENT WAS DEPLOYED, THE STENT DELIVERY SYSTEM BECAME STUCK ON THE WIRE, SO BOTH THE STENT DEPLOYMENT SYSTEM AND THE WIRE HAD TO BE REMOVED TOGETHER. WIRE POSITIONING WAS LOST. THEY HAD TO RE-WIRE THE VESSEL AND CONTINUED WITH THE PROCEDURE. A 6X100 INNOVA WAS ADDITIONALLY IMPLANTED TO STENT THE FULL LENGTH OF THE LESION OVER A BENTSON WIRE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7007561 ↗
• InjuryOct 26, 2017Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT AND STENT ELONGATION OCCURRED. THE LONG, DIFFUSE, CHRONIC TOTAL OCCLUSION (CTO) LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS FROM THE ORIGIN OF THE SFA ALL THE WAY TO THE POPLITEAL AND BELOW THAT TO THE TRIFURCATION. A 6 X 200 X 130 INNOVA¿ STENT WAS ADVANCED CONTRALATERAL OVER AN UNKNOWN GUIDEWIRE AND STENT DEPLOYMENT WAS INITIATED FROM THE POPLITEAL COMING BACK UP THE SFA. AT SOME POINT, THERE WAS AN ISSUE WITH DEPLOYMENT. THE PHYSICIAN WAS NOT SURE IF THE STENT STOPPED DEPLOYING OR HE PULLED BACK ON THE PULL GRIP TOO SOON. THE STENT WAS DEPLOYED COMPLETELY BUT WAS STRETCHED ALL THE WAY INTO THE EXTERNAL ILIAC AND THE INTEGRITY OF THE STENT WAS COMPROMISED. FOUR ADDITIONAL STENTS WERE PLACED FROM THE BEGINNING TO THE END OF THE STRETCHED STENT. THERE WAS A GOOD RESULT FOR THE PATIENT WITH NO ADDITIONAL COMPLICATIONS. THE PROCEDURE WAS COMPLETED AND THE PATIENT¿S STATUS WAS REPORTED AS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6980915 ↗
• MalfunctionOct 5, 2017Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE CATHETER WAS STUCK ON THE GUIDEWIRE. A 6 X 200 X 130 INNOVA¿ STENT WAS SELECTED FOR A PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER THE STENT WAS DEPLOYED, THE DELIVERY CATHETER COULD NOT BE REMOVED OVER THE .035 NON-BSC WIRE. THE WIRE WAS STUCK IN THE CATHETER. THE ENTIRE SYSTEM WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH THIS STENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS REPORTED AS FINE AND HEALTHY POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6918847 ↗
• InjuryOct 3, 2017Fracture; Difficult to Remove; Stretched; Activation, Positioning or Separation Problem; Fracture; Difficult to Remove; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT, STENT MIGRATION AND STENT FRACTURE OCCURRED. THE PATIENT PRESENTED WITH A COMPLETE OCCLUSION FROM THE DISTAL AORTA THROUGH THE LEFT POPLITEAL. THE TARGET LESION WAS LOCATED IN THE CALCIFIED DISTAL AORTA THROUGH THE LEFT POPLITEALL ARTERY. THE PATIENT WAS ACCESSED THROUGH THE LEFT BRACHIAL ARTERY AND A 6 FR NON BSC GUIDE SHEATH WAS PLACED DOWN INTO THE LEFT COMMON FEMORAL ARTERY. A .035¿ NON BSC WIRE WAS ADVANCED ACROSS THE OCCLUSION AND DOWN THROUGH THE POPLITEAL ARTERY TO BELOW THE KNEE. THE LESION WAS THEN PREDILATED WITH A 4 MM BALLOON AND THEN A 6X200MM INNOVA¿ STENT WAS INTRODUCED AND ADVANCED WITH DIFFICULTIES. THE STENT DELIVERY SYSTEM WAS ABLE TO ADVANCE TO PROXIMAL POPLITEAL ARTERY AND DEPLOYMENT WAS INITIATED. A SHORT SEGMENT OF THE STENT WAS DEPLOYED UTILIZING THE THUMB WHEEL, APPROXIMATELY 40MM. A ¿CRACKING¿ NOISE WAS HEARD AND THE THUMB WHEEL WOULD NO LONGER RATCHET TO DEPLOY THE STENT. THE THUMB WHEEL SPUN LOOSELY. THE PHYSICIAN ATTEMPTED TO PULL THE DEPLOYMENT TAB BUT THAT WAS MOVING LOOSE AND FREELY BACK AND FORTH WITHOUT FURTHER DEPLOYING THE STENT. THE PHYSICIAN THEN ATTEMPTED TO PULL THE STENT CATHETER BACK INTO THE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6912904 ↗
• InjurySep 5, 2017Fracture; Stretched; Activation, Positioning or Separation Problem; Fracture; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED RESULTING IN A FRACTURED STENT AND PATIENT SURGERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN A HEAVILY CALCIFIED AND LITTLE TO NON TORTUOUS LESION LOCATED IN THE RIGHT LEG. A 7 FRENCH 45CM NON BSC SHEATH AND AN AMPLATZ SUPER STIFF 260 GUIDEWIRE WERE ADVANCED VIA A CONTRALATERAL APPROACH. THE LESION WAS PRE-DILATED. A 6X200X130 INNOVA¿ STENT WAS ADVANCED AND DEPLOYMENT WAS INITIATED. THE STENT DEPLOYED TO APPROXIMATELY 10-20MM AND DEPLOYMENT STOPPED. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT AND DELIVERY SYSTEM TOGETHER AS ONE UNIT. THE DEPLOYED SECTION OF THE STENT THAT WAS APPOSED TO THE VESSEL WALL ELONGATED AND SUBSEQUENTLY FRACTURED IN THE REMOVAL PROCESS. A PORTION OF THE STENT WAS CAUGHT ON THE SHEATH AND BROKE OFF INSIDE THE VESSEL. THE REMAINDER OF THE STENT THAT WAS CONTAINED INSIDE THE DELIVERY DEVICE WAS REMOVED. THE PATIENT WAS THEN SENT TO SURGERY TO REMOVE THE FRACTURED STENT AND AN ARTERIAL BILE PATCH. THERE WERE NO FURTHER PATIENT COMPLICATIONS. THE SURGERY WAS SUCCESSFUL AND THE PATIENT WAS IN STABLE CONDITION POST SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6842829 ↗
• MalfunctionAug 18, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED. A 6 X 200 X 130 INNOVA¿ STENT WAS SELECTED FOR A PROCEDURE IN THE TOTALLY OCCLUDED AORTA FEMORAL. DURING THE PROCEDURE INSIDE THE PATIENT, THE DEVICE PARTIALLY DEPLOYED. THE HANDLE WAS OPENED AND A PIN AND PULL PROCEDURE WAS USED TO COMPLETE THE DEPLOYMENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6804701 ↗
• InjuryJul 19, 2017Fracture; Difficult to Remove; Stretched; Malposition of Device; Activation, Positioning or Separation Problem; Fracture; Difficult to Remove; Stretched; Malposition of Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DEPLOYMENT DIFFICULTIES, STENT DAMAGE/FRACTURE, AND REMOVAL DIFFICULTIES OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NORMALLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY(SFA). THE LESION WAS NOT PRE-DILATED. A 6 X 200 X 130 INNOVA¿ STENT WAS ADVANCED OVER A .035 GUIDEWIRE CONTRALATERAL TO THE TARGET LESION AND STENT DEPLOYMENT WAS INITIATED. AFTER APPROXIMATELY 70% OF THE STENT WAS DEPLOYED, THE DEPLOYMENT THUMBWHEEL AND PULL-GRIP STOPPED WORKING. AFTER A FEW UNSUCCESSFUL ATTEMPTS TO GET THE DEPLOYMENT MECHANISM WORKING, THE PHYSICIAN PULLED BACK ON THE STENT DELIVERY SYSTEM AND THE STENT MOVED AND STRETCHED FROM THE DISTAL SFA ALL THE WAY TO THE FEMORAL ARTERY. THE STENT WAS DEPLOYED IN THE COMMON FEMORAL - EXTERNAL ILIAC AREA. THE PROXIMAL PART OF THE STENT BROKE. THE DELIVERY SYSTEM AND WIRE WERE UNABLE TO REMOVED FROM THE 45CM INTRODUCER SHEATH INITIALLY. ACCESS WAS GAINED ANTEGRADE ON THE LEFT SIDE, AND THE PHYSICIAN WAS ABLE TO ADVANCE A NON-BSC STENT TO THE TARGET LESION AND DEPLOY THIS STENT. THE PHYSICIAN WAS EVENTUALLY ABLE TO REMOVE THE STENT DELIVERY SYSTEM, WIRE, AND SHEATH TOGETHER FROM THE RIGHT SIDE AND THE PROCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6726535 ↗
• MalfunctionJul 19, 2017Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED LEFT POPLITEAL AND SUPERFICIAL FEMORAL ARTERY. A 45CM 6F NON BSC GUIDING SHEATH AND A 300CM V-18 GUIDEWIRE WERE INSERTED AND ADVANCED INTO POSITION. PRE-DILATION WAS PERFORMED USING A 4MMX150MM STERLING BALLOON. THE 6X200X130MM INNOVA¿ STENT WAS INTRODUCED VIA A CONTRALATERAL APPROACH THEN ADVANCED AND DEPLOYMENT WAS INITIATED VIA THE DEPLOYMENT THUMBWHEEL. STENT DEPLOYMENT STOPPED AFTER 30MM OF THE STENT WAS UNSHEATHED. THE THUMBWHEEL BROKE AND THE PULL GRIP WAS UNABLE TO UNSHEATHE THE STENT. THE STENT WAS THEN PULLED BACK INTO THE GUIDING SHEATH, THE STENT STRETCHED AND THE DEVICES WERE REMOVED TOGETHER. A .035MM STIFF GUIDEWIRE WAS THEN ADVANCED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 6X200X130MM INNOVA¿ STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6724352 ↗
• InjuryJul 10, 2017Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED AND A STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6X200X130 INNOVA¿ STENT WAS ADVANCED TO TREAT THE LESION. STENT DEPLOYMENT WAS INITIATED VIA THE THUMBWHEEL; HOWEVER, THE THUMBWHEEL STOPPED CLICKING. THE PULL GRIP WAS ALSO ATTEMPTED MANUALLY BUT THE STENT DID NOT DEPLOY. THE INNOVA¿ STENT EVENTUALLY FRACTURED. ATTEMPTS WERE MADE TO RETRIEVE THE FRACTURED STENT WITH A SNARE; HOWEVER, THESE WERE UNSUCCESSFUL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6698925 ↗
• MalfunctionMay 31, 2017Bent; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Bent; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS 80-100% STENOSED AND MEDIUM TO HIGHLY CALCIFIED AND TORTUOUS. FOLLOWING PRE-DILATION, A 6X200X130MM INNOVA¿ STENT WAS ADVANCED VIA AN IPSILATERAL APPROACH. THE INNOVA STENT WAS TRACKED OVER A .014 GUIDEWIRE AND DEPLOYMENT WAS INITIATED WITH THE THUMB WHEEL. THE PULL GRIP WAS UTILIZED TO DEPLOY THE REMAINDER OF THE STENT; HOWEVER, A ¿SNAP¿ WAS HEARD AND THE PULL GRIP WAS NO LONGER FUNCTIONAL. THE PHYSICIAN THEN PERFORMED MULTIPLE MANEUVERS IN ORDER TO GET THE STENT TO RELEASE AND REMOVED THE DELIVERY SYSTEM. THE STENT WAS STRETCHED OR ELONGATED AS A RESULT OF THE DEPLOYMENT DIFFICULTIES. THE PROCEDURE WAS COMPLETED BY BALLOONING INSIDE OF THE INNOVA. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6601040 ↗
• MalfunctionMay 24, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DEPLOYMENT DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 6X200X130MM INNOVA¿ STENT WAS SELECTED TO TREAT THE LESION ALONG WITH A .014¿ GUIDEWIRE. DEPLOYMENT WAS INITIATED VIA THE THUMBWHEEL AND 120MM OF THE INNOVA¿ STENT WAS DEPLOYED. THE PHYSICIAN THE PROCEEDED TO DEPLOY THE REMAINDER 10MM OF THE STENT VIA THE PULL GRIP, HOWEVER THE PULL GRIP WOULD NOT RELEASE THE REMAINDER OF THE STENT. IN ATTEMPTS TO DEPLOY THE STENT, THE DEPLOYMENT HANDLE WAS THEN OPENED AND IT WAS OBSERVED THAT THE INNER LUMEN WAS KINKED. THE PHYSICIAN BACKLOADED A V18 STIFF WIRE THROUGH THE INNER LUMEN TO STRAIGHTEN THE LUMEN OUT AND THEN HE PROCEEDED TO SUCCESSFULLY DEPLOY THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6587071 ↗
• InjuryMay 12, 2017Difficult or Delayed Positioning; Fracture; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PARTIALLY DEPLOYED STENT FRACTURED. THE TARGET LESION WAS LOCATED IN THE 70-90% STENOSED, SEVERELY CALCIFIED, AND MODERATELY TORTUOUS RIGHT EXTERNAL ILIAC. A 6 X 200 X 130 INNOVA¿ STENT WAS SELECTED FOR USE. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE LESION WITH A 6FRENCH 45CM NON-BSC SHEATH EXTENDED OVER THE BIFURCATION AND DOWN THE RIGHT COMMON ILIAC. THE STENT WAS ATTEMPTED TO BE DEPLOYED OVER A 0.35' NON-BSC GUIDEWIRE. ABOUT 4 MM OF THE STENT WAS DEPLOYED BEFORE THE THUMBWHEEL STOPPED WORKING. THERE WAS AN ABNORMALLY HIGH RESISTANCE WHEN TURNING THE THUMBWHEEL. THE PHYSICIAN ATTEMPTED TO COMPLETE DEPLOYMENT WITH THE PULL GRIP, BUT THIS ALSO FAILED. THE HANDLE WAS OPENED AND IT WAS ATTEMPTED TO DEPLOY THE STENT BY PINING THE INNER SHAFT AND BRINGING THE OUTER SHAFT TOWARD THE INNER, BUT THIS ALSO FAILED. THE STENT WAS THEN PULLED BACK INTO THE SHEATH LEAVING ABOUT A 4 MM FRACTURED SEGMENT OF THE STENT WITHIN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC COVER STENT. THE COVER STENT WAS DEPLOYED THROUGH THE CENTER OF THE 4 MM INNOVA SEGMENT COMPLETELY COVERING IT. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS AND THE PATIENT WAS OK.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6565056 ↗
• MalfunctionApr 17, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DEPLOYMENT DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE PATIENT¿S LEFT LEG. A 6X200X130MM INNOVA¿ STENT WAS ADVANCED TO THE TARGET LESION AND DEPLOYMENT WAS INITIATED VIA ROTATION OF THE THUMB WHEEL, HOWEVER THE THUMB WHEEL STOPPED AFTER 70% OF THE STENT WAS DEPLOYED. THE WHITE ARROW ON THE HANDLE WAS ALSO ¿STUCK¿ AS IT DID NOT ALLOW THE PHYSICIAN TO DEPLOY THE OTHER 30% OF THE STENT. IT WAS REPORTED THAT THE STENT EVENTUALLY DEPLOYED, HOWEVER THE PHYSICIAN DECIDED TO REMOVE THE STENT FROM THE PATIENT WITH NO COMPLICATIONS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THE PATIENT¿S STATUS WAS FINE POST PROCEDURE. THE PATIENT IS SCHEDULED TO RETURN TO THE FACILITY ON A LATER DATE FOR TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6497961 ↗
• InjuryApr 17, 2017Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT AND REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 6 X 200 X 30 INNOVA¿ STENT DEPLOYED ONLY 50% IN THE MID TO PROXIMAL SFA AND THE ROLLER BALL JUST STOPPED, THEN ¿BROKE¿. AN ATTEMPT TO ¿CRACK THE ROLLERBALL HOUSING¿ WAS MADE HOWEVER, IT STILL WOULD NOT DEPLOY, IT WOULDN¿T RELEASE. THE PATIENT HAD TO UNDERGO SURGERY TO HAVE THE STENT AND SHEATH REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE. HOSPITAL DISCHARGE OCCURRED 24 HOURS POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6497945 ↗
• InjuryMar 23, 2017Fracture; Stretched; Activation, Positioning or Separation Problem; Fracture; Stretched; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DEPLOYMENT DIFFICULTIES AND STENT FRACTURE OCCURRED. A 6 X 200 X 130 INNOVA¿ STENT WAS USED FOR A PERIPHERAL STENTING PROCEDURE. THE TARGET LESION WAS VERY CALCIFIED AND 100% STENOSED. FOLLOWING PRE-DILATION, THE STENT WAS ADVANCED AND DEPLOYMENT INITIATED. HALF WAY THROUGH DEPLOYMENT USING THE THUMB WHEEL, THE STENT BECAME STUCK. THE PHYSICIAN USED A LOT OF FORCE IN AN ATTEMPT TO GET THE THUMB WHEEL TO WORK BUT THIS WAS NOT SUCCESSFUL. THE PHYSICIAN THEN PULLED THE STENT BACK; HOWEVER, THE STENT BEGAN TO ELONGATE AND EVENTUALLY FRACTURE. A PORTION OF THE STENT WAS LEFT IN THE PATIENT. THIS WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6429889 ↗
• InjuryMar 21, 2017Bent; Activation, Positioning or Separation Problem; Bent; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT ELONGATED. A 6 X 200 X 130 INNOVA STENT WAS SELECTED FOR A PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. MID WAY THROUGH DEPLOYING THE STENT INSIDE THE PATIENT, IT WAS NOTED THE STENT WAS COMING OUT ABNORMALLY. THE STENT ELONGATED BY 5CM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AS THE PHYSICIAN FINISHED DEPLOYING THE STENT. ANOTHER STENT, HOWEVER, WAS PLACED INSIDE OF IT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6423101 ↗
• InjuryMar 16, 2017Bent; Activation, Positioning or Separation Problem; Bent; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT DEPLOYMENT DIFFICULTIES AND STENT STRETCHING OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT GROIN ANTEGRADE APPROACH. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 6MM-200MM/130CM INNOVA STENT WAS ADVANCED TO TREAT THE LESION. AFTER THE THUMBWHEEL WAS FULLY TURNED TO THE STOP POINT, PIN PULL WAS USED WITH THE WHITE DEPLOYMENT HANDLE AND THE BLUE PULL BACK HANDLE OVER THE WIRE. HOWEVER THE STENT DID NOT DEPLOY AND IT TOOK MANY ADDITIONAL TECHNICAL STEPS TO ALLOW THE STENT TO BE SAFELY DEPLOYED. THE PATIENT SUFFERED NO ADVERSE CONSEQUENCES AND THE OCCLUDED TARGET LESION BECAME PATENT AND TECHNICALLY GOOD, BUT THE ORIGIN OF THE PROFUNDA WAS COVERED AS THE STENT WAS DEPLOYED AT LEVEL OF DISTAL RIGHT COMMON FEMORAL ARTERY AND WAS STRETCHED. BALLOON CATHETER WAS USED TO OPEN THE STENT INTERTICE IN AREA OF THIS PROFUNDA TO ASSURE NO ISSUE AND A STERILE WIRE CUTTER WAS ALSO USED AT ONE POINT IN THIS CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6411684 ↗
• MalfunctionMar 7, 2017Difficult or Delayed Positioning; Stretched; Delivery System Failure; Difficult or Delayed Positioning; Stretched; Delivery System Failure

  IT WAS REPORTED THAT STENT DAMAGE AND DEPLOYMENT DIFFICULTIES OCCURRED. THE 50% STENOSED, MODERATELY CALCIFIED LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6 X 200 X 130 INNOVA¿ WAS ADVANCED TO THE SFA VIA A CONTRALATERAL APPROACH AND DEPLOYMENT WAS INITIATED WITH THE THUMB WHEEL UNTIL THE WHITE ARROW WAS VISUALIZED. DEPLOYMENT WAS SWITCHED TO THE PULL GRIP WHEN THERE WAS DIFFICULTY PULLING THE KNOB TO FINISH DEPLOYMENT AND APPROXIMATELY 10CM OF THE STENT ELONGATED. THE INNOVA¿ DELIVERY SYSTEM WAS WALKED OFF THE GUIDE WIRE IN 3 PIECES; FIRST THE OUTER CATHETER WAS REMOVED AND THEN THE INNER CATHETER. THE LESION WAS DILATED WITH A BALLOON TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6386004 ↗
• MalfunctionFeb 27, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA AN ANTEGRADE APPROACH WITH A STRAIGHT ANGLE. THE CHRONICALLY TOTAL OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN EXPOSED THE VESSEL AND DID AN ENDARTERECTOMY AND PATCH GRAFT FIRST. AFTER PRE-DILATION, A 6 MM-200 MM/130 CM INNOVA STENT WAS ADVANCED TO THE TARGET LESION. THE THUMBWHEEL WAS USED WITH NORMAL FORCE UNTIL THE WHITE ARROW WAS VISIBLE. THEN THE PULL GRIP WAS USED TO DEPLOY THE STENT. HOWEVER, THE STENT WAS FORESHORTENED, THUS ANOTHER NON-BSC STENT WAS PLACED OVERLAPPING THE INNOVA STENT. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6361496 ↗

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-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
• 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