Innova™ Vascular H74939293061530Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729874041), received between Feb 27, 2017 and Apr 8, 2026 — classified as 7 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (5 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Nonstandard Device; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE STENT APPEARED SHORTER THAN EXPECTED, REQUIRING AN ADDITIONAL DEVICE. THE TARGET LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. A 6 X 150 X 130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN OBSERVED THAT THE DEPLOYED STENT LENGTH APPEARED SHORTER THAN ANTICIPATED BUT PROCEEDED WITH DEPLOYMENT. ONCE FULLY RELEASED WITHIN THE VESSEL, THE STENT CONTINUED TO PRESENT AS SHORTER THAN EXPECTED. THIS OBSERVATION WAS FURTHER SUBSTANTIATED WHEN A 5 X 150 CHARGER BALLOON WAS ADVANCED TO THE LESION AND FOUND TO BE SIGNIFICANTLY LONGER THAN THE STENT IN PLACE. IT WAS SUBSEQUENTLY SUSPECTED THAT THE STENT DEPLOYED, LABELED AS A 6 X 150, MAY HAVE ACTUALLY BEEN A 6 X 100. THE INTERVENTION WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817808 ↗
• MalfunctionApr 30, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT OCCURRED. THE LIMITED STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PERIPHERAL ARTERY. A 6 X 150 X 130 INNOVA VASCULAR SELF EXPANDING STENT WAS SELECTED FOR USE. DURING DEPLOYMENT, THE THIRD CLICK SOUNDED DIFFERENT AND THE STENT FAILED TO DEPLOY ANY FURTHER. THE STENT AND CATHETER SHAFT WERE SLOWLY AND CAREFULLY REMOVED FROM THE BODY. THE STENT CATHETER WAS PLACED UNDER FLUOROSCOPY TO ENSURE THAT THE STENT WAS STILL ON THE DEPLOYMENT SHAFT. THE STENT WAS SAFELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936276 ↗
• InjuryDec 3, 2024Fracture; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY BROKE, AND THE PROCEDURE WAS NOT COMPLETED. VASCULAR ACCESS WAS OBTAINED VIA BRACHIAL APPROACH. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6 X 150 X 130 INNOVA VASCULAR SELF-EXPANDING STENT WAS ADVANCED OVER .014 NON-BOSTON SCIENTIFIC GUIDEWIRE THROUGH A 6F X 90CM SHEATH. DURING THE PROCEDURE, THE ROLLER CONTINUED TO CLICK, BUT THE DEPLOYMENT STOPPED, IT WAS ONLY ABOUT 20MM OF THE STENT WAS DEPLOYED. IT WAS ATTEMPTED TO MANUALLY DEPLOY THE STENT BY PULLING THE BLUE GRIP UNTIL PAST WHITE ARROW, BUT IT WAS UNSUCCESSFUL. EVENTUALLY, WHILE TRYING TO DEPLOY AND REMOVE THE STENT, IT PARTIALLY BROKE. THE OTHER FRACTURED PART WAS STILL ATTACHED IN THE DEPLOYMENT SYSTEM WHEN REMOVED ALONG WITH THE 6F X 90CM SHEATH. THE DETACHED PORTION OF THE STENT REMAINS IMPLANTED IN THE SFA. THE PROCEDURE WAS NOT COMPLETED, AS THE PATIENT STILL HAD A BLOOD FLOW IN THE SFA, NOTHING ELSE WAS DONE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20836398 ↗
• MalfunctionJul 25, 2023Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEVICE WAS DIFFICULT TO CROSS THE VESSEL AND PREMATURELY DEPLOYED. THIS 6 X 150 X 130 INNOVA VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A STENT PLACEMENT PROCEDURE. THE DEVICE WAS ABLE TO BE PASSED THROUGH A 6 FR SHEATH BUT WOULD NOT PASS THE POPLITEAL VESSEL. THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT PART OF THE STENT WAS PROTRUDING OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17389383 ↗
• MalfunctionNov 28, 2022Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WAS DIFFICULTY ADVANCING TO AND REMOVING THE DEVICE FROM THE TARGET LESION. IT WAS ADDITIONALLY REPORTED THAT UPON REMOVAL, THE DEPLOYMENT SHEATH APPEARED BURRED. THE PATIENT UNDERWENT A PERIPHERAL ANGIOPLASTY PROCEDURE OF THE RIGHT LOWER EXTREMITY WITH PEDAL ACCESS AND A 6F NON-BSC INTRODUCER. THE MILDLY TORTUOUS TARGET LESIONS WERE SEVERELY CALCIFIED, WITH STENOSIS MEASURING 84% IN THE POSTERIOR TIBIAL (PT), 41% IN THE POPLITEAL ARTERY, AND 93% IN THE SUPERFICIAL FEMORAL ARTERY (SFA). INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO CONFIRM THE CALCIFICATION. THE ROTAPRO 1.75 X 135 WAS SELECTED TO OPEN THE BLOCKAGES. THE SFA WAS PREDILATED USING A CHARGER 5.0 X 120. THE INNOVA 6 X 120 X 130 WAS THEN INSERTED BUT WOULD NOT ADVANCE ALL THE WAY TO DEPLOYMENT SITE. THE INNOVA WAS REMOVED UNDEPLOYED WITH DIFFICULTY. UPON INSPECTION, THE TIP OF THE OUTER RETRACTABLE DEPLOYMENT SHEATH APPEARED BURRED, AND THE PHYSICIAN ELECTED TO REPLACE THE DEVICE WITH ANOTHER STENT RATHER THAN REINSERT. THE PATIENT WAS THEN DILATED USING A COYOTE 2.5 X 120 BALLOON. A NEW INNOVA 6 X 120 X 130 WAS THEN INSERTED WITHOUT RESISTANCE AND DEPLOYED WITHOUT ANY ISSUES. THE DELIVERY SYSTEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874697 ↗
• MalfunctionDec 27, 2021Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08DEC2021. A 6MM X 150MM X 130CM INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE IN A STENTING PROCEDURE WITHIN THE SUPERFICIAL FEMORAL ARTERY. UPON OPENING THE PACKAGE, THE TIP OF THE CATHETER LOOKED DEFECTIVE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED PARTIAL DEPLOYMENT OF THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087652 ↗
• InjuryJun 3, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE STENT FRACTURED AND OCCLUDED. IT WAS TREATED WITH A LASER, DRUG-COATED BALLOONS, AND ANOTHER STENT WAS PLACED OVER THE FRACTURED STENT. A 6 X 150 X 130 INNOVA SELF EXPANDING STENT WAS PREVIOUSLY PLACED ON (B)(6) 2020 AT THE MILDLY TORTUOUS PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY. AT A FOLLOW UP APPOINTMENT, FOR LEG PAIN ON (B)(6) 2021, AN ANGIOGRAM WAS PERFORMED. THE ANGIOGRAM REVEALED THAT THE PREVIOUSLY PLACED INNOVA STENT WAS COMPLETELY FRACTURED IN 2 PLACES AND THE VESSEL STENTS WERE COMPLETELY OCCLUDED. THIS WAS TREATED WITH LASER, A DRUG COATED BALLOON, AND A NON-BSC STENT (PLACED OVER THE FRACTURED STENT).

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 11931635 ↗
• InjuryMar 25, 2021Break; Entrapment of Device; Activation, Positioning or Separation Problem; Break; Entrapment of Device; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT BECAME STUCK ON THE GUIDEWIRE, THE STENT PARTIALLY DEPLOYED, AND A SMALL PORTION OF THE STENT BROKE OFF IN THE ARTERY. A 6MM X 150MM X 130CM INNOVA VASCULAR SELF-EXPANDING STENT AND A 300CM V-18 CONTROL WIRE WERE SELECTED FOR USE IN A PROCEDURE IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A CONTRALATERAL APPROACH WAS USED TO ACCESS THE LESION. AFTER PRE-DILATING WITH A 4MM BALLOON FOLLOWED BY A 5MM BALLOON, THE INNOVA DEVICE WAS INSERTED INTO THE BODY OVER THE EXISTING V-18 CONTROL WIRE. UPON GETTING THE STENT INTO POSITION IN THE RIGHT SFA, IT WAS NOTED THAT THE STENT APPEARED TO BE GETTING STUCK ON GUIDEWIRE AND WOULD NOT MOVE FREELY. IT WAS DECIDED TO PROCEED WITH STENT DEPLOYMENT SINCE THE STENT WAS IN THE CORRECT LOCATION. THE STENT FLOWERED OPEN APPROXIMATELY 2% (APPROXIMATELY 2MM IN DIAMETER BY 2MM IN LENGTH) AND THEN STOPPED. THE SYSTEM WAS JAMMED, AND SUBSEQUENTLY, THE ENTIRE SYSTEM (V-18 CONTROL WIRE AND INNOVA DELIVERY SYSTEM) WAS PULLED BACK INTO THE 6F NON-BOSTON SCIENTIFIC SHEATH, WHICH WAS THEN REMOVED FROM THE LEFT FEMORAL ARTERY. IT WAS LATER DISCOVERED THAT A SMALL PORTION OF THE STENT THAT FLOWERED OPEN BROKE OFF INSIDE THE LEFT F

  Patient problems: Foreign Body In Patient

  MAUDE report 11570729 ↗
• MalfunctionNov 12, 2020Premature Activation; Premature Activation

  IT WAS REPORTED THE STENT PREMATURELY DEPLOYED. A 6 X 150 X 130 INNOVA VASCULAR WAS SELECTED FOR USE. THE INNOVA STENT STARTED TO DEPLOY WITHIN THE SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10829753 ↗
• MalfunctionMay 28, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED AND RESCHEDULED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 6X150X130 INNOVA VASCULAR STENT WAS SELECTED FOR USE. IPSILATERAL ANTEGRADE APPROACH WAS PERFORMED. THE SHEATH WAS INSERTED AT A SLIGHTLY RIGHT ANGLE. AFTER PASSING THE GUIDEWIRE IN BOTH DIRECTIONS, PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. DURING INSERTION OF THE INNOVA, THE SHAFT WAS LONG AND COMPLICATED TO HANDLE AND THE SHAFT KINKED MIDWAY OUTSIDE THE PATIENT. THE STENT WAS NOT DEPLOYED. DUE TO THE PATIENT'S PHYSIQUE, THE SHEATH ALSO KINKED, SO IT WAS DIFFICULT TO CONTINUE THE TREATMENT. THE PROCEDURE WAS RESCHEDULED FOR A LATER DATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10097147 ↗
• MalfunctionMar 12, 2020Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED. A 6X150X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR A PROCEDURE IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION HAD MINIMAL TORTUOSITY AND PRE-DILATION WAS PERFORMED WITH NO YIELDING OF THE CALCIUM. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE LESION. DURING DEPLOYMENT, THE STENT STOPPED DEPLOYING AFTER 5CM. THERE WAS SOME DIFFICULTY REMOVING THE STENT. THE ENTIRE DELIVERY SYSTEM AND STENT WERE ABLE TO BE PULLED BACK INTO THE SHEATH AND REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT ANY STENT BEING USED AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9824530 ↗
• MalfunctionNov 26, 2019Premature Activation; Premature Activation

  IT WAS REPORTED THAT AN INADVERTENT DEPLOYMENT OCCURRED. A 6X150X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR A PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING PREPARATION, IT WAS DISCOVERED THAT THE STENT WAS INADVERTENT DEPLOYED APPROXIMATELY 1 MM WHEN THE PACKAGE WAS OPENED. THE DEVICE DID NOT ENTER THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER INNOVA DEVICE. THERE WERE NO COMPLICATIONS TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9378779 ↗
• MalfunctionJul 31, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK ON THE GUIDEWIRE. AN INNOVA 6X150X130 SELF EXPANDING STENT WAS SELECTED TO BE IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AFTER THE STENT WAS SUCCESSFULLY DEPLOYED, THE CATHETER BECAME STUCK ON THE WIRE UPON RETRIEVAL. THE DEPLOYMENT SYSTEM AND WIRE WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8846235 ↗
• InjuryFeb 25, 2019Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED THAT THE STENT SHORTENED AFTER DEPLOYMENT. A 6X150MM INNOVA SELF EXPANDING STENT WAS SELECTED FOR USE FOR AN ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE IN THE HEAVILY CALCIFIED, AND 87% STENOSED, RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). AFTER PRE-DILATION USING A CHARGER BALLOON, THE INNOVA STENT WAS USED. THE PHYSICIAN HAD DIFFICULTY MAINTAINING A GOOD SUPPORT RAIL, AND THERE WAS SOME DIFFICULTY DEPLOYING THE STENT. AFTER THE STENT WAS DEPLOYED, THE STENT WAS OBSERVED TO SHORTEN FROM 150MM TO ABOUT 80MM. THE PROCEDURE WAS COMPLETED USING ANOTHER INNOVA STENT TO COVER THE LESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT'S STATUS WAS REPORTED AS FINE. IT WAS FURTHER REPORTED THAT THE DIFFICULTIES DURING DEPLOYMENT OF THE STENT WERE DUE TO THE STENT PREMATURELY DEPLOYING IN THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367438 ↗
• MalfunctionJan 31, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS STUCK ON THE WIRE. A 6X150X130 INNOVA STENT WAS SELECTED TO TREAT A PREVIOUSLY PLACED 6X120 NON-BSC STENT IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). VASCULAR ACCESS WAS GAINED THROUGH THE LEFT GROIN. A .035 260CM MAGIC TORQUE GUIDEWIRE WAS ADVANCED AND THE LESION WAS PRE-DILATED WITH A 6X200 MUSTANG BALLOON CATHETER. THE INNOVA STENT WAS THEN ADVANCED AND DEPLOYED SUCCESSFULLY. FOLLOWING DEPLOYMENT, THE STENT DELIVERY SYSTEM WAS NOT ABLE TO BE REMOVED OVER THE WIRE. THE DELIVERY SYSTEM WAS STUCK ON THE WIRE. EVERYTHING BUT THE SHEATH WAS REMOVED TOGETHER FROM THE PATIENT. A NEW WIRE WAS INSERTED, AND THE STENT WAS POST DILATED WITH THE 6X200 MUSTANG BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293616 ↗
• MalfunctionOct 18, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT PARTLY INADVERTENTLY DEPLOYED. A 6 X 150 X 130 INNOVA WAS SELECTED FOR A SUPERFICIAL FEMORAL ARTERY STENTING PROCEDURE. UPON REMOVAL FROM THE PACKAGE, IT WAS OBSERVED THAT THE STENT WAS PARTIALLY DEPLOYED EVEN THOUGH THE THUMBWHEEL LOCK WAS STILL IN PLACE. THE DEVICE WAS NOT INSERTED INTO THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS. RETURNED PRODUCT CONSISTED OF AN INNOVA SELF-EXPANDING STENT DELIVERY SYSTEM (SDS). THE OUTER SHEATH, MID-SHAFT, AND THE REMAINDER OF THE DEVICE WERE CHECKED FOR DAMAGE. VISUAL EXAMINATION SHOWED NO DAMAGE ON THE SHAFT. THE STENT WAS PARTIALLY DEPLOYED 2.2CM FROM THE DISTAL END OF THE MARKERBAND. THE PULL HANDLE WAS PULLED APPROXIMATELY 1.7CM FROM THE HANDLE. WITH THE PULL HANDLE MOVED FROM THE START POSITION THIS IS CONSISTENT WITH THE HANDLE BEING PULLED. THE YELLOW THUMBWHEEL LOCK WAS RETURNED ON THE DEVICE. WITH INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7981354 ↗
• MalfunctionSep 26, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP AND INNER SHAFT SEPARATED FROM THE REST OF THE DEVICE. AN INNOVA STENT WAS SELECTED FOR USE FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS ADVANCED CONTRALATERAL AND THE STENT WAS DEPLOYED WITHOUT ISSUE. WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE SYSTEM AFTER STENT PLACEMENT, THE INNER SHAFT, INCLUDING THE DISTAL TIP, WAS FOUND TO BE SEPARATED COMPLETELY. THERE WAS NO FEELING OF RESISTANCE. THE INNER SHAFT AND DISTAL TIP REMAINED ON THE GUIDEWIRE, AND THE SYSTEM WAS ABLE TO BE REMOVED COMPLETELY FROM THE BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS POST PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7911600 ↗
• MalfunctionAug 20, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 6X150X130 INNOVA STENT WAS SELECTED FOR USE. DURING PREPARATION, WHILE OUTSIDE OF THE PATIENT, THE PHYSICIAN OPENED THE PACKAGE AND IT WAS OBSERVED THAT THE STENT WAS PARTIALLY DEPLOYED. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7799611 ↗
• InjuryMay 8, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID# 2134265-2018-04116. THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS OF THE 5.0 X40 X130 INNOVA STENT THAT WAS PLACED IN THE RIGHT POPLITEAL ARTERY ON (B)(6) 2017. THE ISR WAS TREATED WITH ATHERECTOMY AND BALLOON ANGIOPLASTY, RESULTING IN A PATENT RIGHT POPLITEAL. IT WAS ALSO OBSERVED IN THE SAME PROCEDURE THAT IN-STENT RESTENOSIS OCCURRED IN THE 6.0 X150 X130 INNOVA STENT THAT WAS PLACED IN THE RIGHT SFA ON (B)(6) 2017. THE ISR WAS TREATED WITH ATHERECTOMY AND BALLOON ANGIOPLASTY, RESULTING IN A PATENT RIGHT SFA. NO FURTHER PATIENT COMPLICATIONS OCCURRED AND PATIENT STATUS POST-PROCEDURE WAS GOOD.

  Patient problems: Reocclusion

  MAUDE report 7495838 ↗
• MalfunctionMay 7, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS STUCK ON THE WIRE. A 6 X 150 X 130 INNOVA¿ STENT WAS SELECTED FOR AN ENDOVASCULAR TREATMENT (EVT) PROCEDURE. THE 99% STENOSED, FOCAL TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE INNOVA STENT WAS ADVANCED IPSILATERAL OVER A .035 NON-BSC WIRE. DILATATION WAS PERFORMED USING A COYOTE BALLOON AND SFA STENTING WAS PERFORMED. AFTER DEPLOYING THE STENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE INNOVA DELIVERY SYSTEM BUT THE SYSTEM BECAME STUCK ON THE WIRE. THE DELIVERY SYSTEM WAS REMOVED TOGETHER WITH THE WIRE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490784 ↗
• MalfunctionMar 14, 2018Entrapment of Device; Entrapment of Device

  SAME CASE AS MDR 2134265-2018-01887. IT WAS REPORTED THAT THE DEVICE WAS STUCK ON THE WIRE. A 6 X 150 X 130 INNOVA¿ AND A 0.035X260 MAGIC TORQUE¿ GUIDEWIRE WERE SELECTED FOR A BALLOON AND STENT PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE STENT WAS DEPLOYED. WHILE ATTEMPTING TO REMOVE THE DEVICE, THE CATHETER BECAME DIFFICULT TO RETRACT OVER THE WIRE. THE PHYSICIAN PULLED THE DELIVERY CATHETER AND THE WIRE OUT TOGETHER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S CONDITION POST PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7338901 ↗
• MalfunctionFeb 8, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE A STENT PLACEMENT PROBLEM OCCURRED. THE TARGET LESION WAS A DISSECTION WHICH ORIGINATED FROM AN ECCENTRIC SMOOTH LESION IN THE MINIMALLY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A CONTRALATERAL APPROACH WAS MADE TO ACCESS THE LESION AND A 6X150X130 INNOVA¿ STENT WAS ADVANCED OVER A .035¿ GUIDEWIRE. THE STENT WAS DEPLOYED WITH NO MECHANICAL ISSUES NOTED; HOWEVER, A PORTION OF THE PROXIMAL END OF THE STENT ENDED UP IN THE COMMON FEMORAL ACROSS THE PROFUNDA. THE STENT WAS NOT STRETCHED OR ELONGATED. THE PATIENT DID NOT RECEIVE ADDITIONAL TREATMENT AND WAS MONITORED OVERNIGHT. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT¿S STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7255241 ↗
• InjuryNov 17, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR 2134265-2017-11104 AND MDR 2134265-2017-11106. 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 7042971 ↗
• MalfunctionFeb 27, 2017Bent; Bent

  IT WAS REPORTED THAT STENT DAMAGE AND DEPLOYMENT FAILURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A 6MM-150MM/130CM INNOVA¿ STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT WAS KINKED AND UNABLE TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME SIZE INNOVA STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6360340 ↗

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