Innova™ Vascular H74939293051530Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729873952), received between Dec 22, 2017 and Mar 15, 2024 — classified as 10 injuries, 10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT LABELING ISSUE OCCURRED. THE PATIENT WAS BEING TREATED FOR PERIPHERAL ARTERIAL DISEASE IN THE LOWER EXTREMITY. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 5 X 150 X 130 INNOVA VASCULAR STENT WAS SELECTED FOR TREATMENT. HOWEVER, A 5 X 120 X 130 INNOVA VASCULAR WAS FOUND INSIDE THE DEVICE PACKAGING AND IT WAS NOTED DURING DEPLOYMENT AFTER THE PACKAGE WAS SCANNED BY CLINICAL STAFF MONITORING THE CASE. THE STENT WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. IT WAS NOTED THAT THE TARGET LESION WAS SUFFICIENTLY COVERED, AS MULTIPLE STENTS WERE ALREADY PLANNED TO BE USED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912472 ↗
• InjuryMar 15, 2024Fracture; Activation, Positioning or Separation Problem; Difficult to Advance; Fracture; Activation, Positioning or Separation Problem; Difficult to Advance

  IT WAS NOTED THAT STENT PARTIAL DEPLOYMENT AND STENT FRACTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT DISTAL SUPERFICIAL FEMORAL ARTERY AND EXTERNAL ILIAC ARTERY. PHYSICIAN HAD CROSSED AN OLD OCCLUDED IN-STENT STENOSIS. A LASER ATHERECTOMY WAS THEN PERFORMED TO PREPARE THE VESSEL PRIOR TO DEPLOYMENT OF THE STENT. AFTERWARDS, A 5 X 150 X 130 INNOVA STENT WAS SENT TO REALIGN THE FRACTURED OLD STENT SEGMENT. HOWEVER, PHYSICIAN STRUGGLED TO TRACK STENT OVER A .014 PT CHOICE WIRE, BUT EVENTUALLY ALIGNED STENT WHERE IT WAS WANTED. DURING THE DEPLOYMENT, IT WAS NOTED THAT THE THUMB WHEEL WAS NOT DEPLOYING THE STENT AND WHEN IT WAS RETRACTED, THE STENT WAS PARTIALLY DEPLOYED ABOUT 10MM. PART OF THE STENT WAS STILL IN THE BODY AS THE REMAINING STENT WAS NOW LOCATED IN THE SHEATH, SO THE SHEATH AND STENT WAS REMOVED TOGETHER. THE PHYSICIAN DECIDED TO SEND A STERLING BALLOON CATHETER TO DEPLOY THE REMAINING STENT PORTION AND THE PROCEDURE WAS COMPLETED WITH A 6X60 INNOVA. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912302 ↗
• MalfunctionJun 5, 2023Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A THE MARKER BAND DISLODGED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND TIGHT SUPERFICIAL FEMORAL ARTERY (SFA). A 5 X 150 X 130 INNOVA VASCULAR WAS SELECTED FOR USE. THE STENT WAS ADVANCED TO THE TARGET LESION WITH SLIGHT RESISTANCE. THE STENT DEPLOYED PROPERLY AND REMAINED IMPLANTED IN THE PATIENT. UPON REMOVAL OF THE DELIVERY SYSTEM, ONE OF THE MARKER BANDS GOT CAUGHT INSIDE THE SHEATH AND CAME OFF OF THE DELIVERY SYSTEM. THE MARKER BAND REMAINED INSIDE THE NON-BOSTON SCIENTIFIC 6F SHEATH DURING REMOVAL OF THE SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059612 ↗
• MalfunctionJan 6, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM WAS DIFFICULT TO REMOVE. A 5MM X 150MM X 130CM INNOVA SELF EXPANDING STENT WAS SELECTED FOR THE TREATMENT OF MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. DURING DEPLOYMENT OF THE STENT, THE NOSE CONE BECAME STUCK ON THE STENT. A BALLOON WAS ADVANCED TO THE LESION TO CREATE MORE SPACE AND REMOVE THE NOSE CONE. THE PROCEDURE WAS COMPLETED USING A BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178953 ↗
• InjuryDec 13, 2021Fracture; Premature Activation; Failure to Advance; Material Deformation; Fracture; Premature Activation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT UPON REMOVAL THE STENT FRACTURED AND A PORTION WAS LEFT UN-RETRIEVED IN THE PATIENT. AN 5MM X 150MM X 130CM INNOVA VASCULAR SELF-EXPANDING STENT WAS CHOSEN FOR A SUPERFICIAL FEMORAL ARTERY (SFA) ANGIOPLASTY AND STENT PLACEMENT TO TREAT PERIPHERAL ARTERY DISEASE. THE TARGET LESION CONTAINED VERY HIGH GRADE STENOSIS (POSSIBLY OCCLUDED) AND WAS SEVERELY CALCIFIED. DURING THE TREATMENT, THE INNOVA STENT CATHETER WOULD NOT CROSS THE LESION ON FIRST ATTEMPT. THE PHYSICIAN REMOVED THE STENT AND EXCHANGED THE WIRE, AND THEN THE LESION WAS PRE-DILATED WITH A 4MM BALLOON BEFORE ATTEMPTING TO CROSS THE LESION AGAIN. A SECOND ATTEMPT TO CROSS THE LESION ALSO FAILED, AND UPON REMOVAL THE STENT STARTED TO DEPLOY AND ELONGATED ACROSS A PORTION OF THE DISEASED SFA BEFORE FRACTURING. THEREFORE, A PORTION OF THE STENT REMAINED IN THE PATIENT UN-RETRIEVED AND A PORTION CAME OUT WITH CATHETER. FURTHER INTERVENTION WAS PERFORMED WHERE THREE ADDITIONAL INNOVA STENTS (5MM X 120MM, 5MM X 100MM, 6MM X 150MM) WERE DEPLOYED TO COVER THE UN-RETRIEVED FRACTURED PORTION OF THE STENT AND LESION. SUBSEQUENTLY, THE SFA WAS OPENED WITH BLOOD FLOW THROUGH ALL STENT. THE PROCEDURE WAS COMPLETED S

  Patient problems: Foreign Body In Patient

  MAUDE report 12986645 ↗
• MalfunctionAug 2, 2021Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A PARTIAL DEPLOYMENT AND STENT FRACTURE OCCURRED. AN INNOVA STENT WAS SELECTED FOR USE DURING A SUPERFICIAL FEMORAL ARTERY STENTING PROCEDURE. DURING DEPLOYMENT, THE STENT DID NOT FULLY DEPLOY ALL THE WAY RESULTING IN HALF OF THE STENT HANGING OUT OF THE CATHETER. A CUT DOWN WAS PERFORMED TO ACCESS THE EXTERNAL ILIAC ARTERY TO RETRIEVE THE FRACTURED PORTION OF THE STENT. NO ADVERSE PATIENT EVENTS WERE REPORTED. THE PATIENT WAS NOTED TO HAVE FULLY RECOVERED FROM THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264498 ↗
• MalfunctionApr 12, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 5X150X130 INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE. AFTER THE DEVICE WAS REMOVED FROM THE PACKAGE AND INSPECTED, IT WAS OBSERVED THAT THE CATHETER WAS PULLED BACK AND THE STENT TIP WAS EXPOSED. A NEW DEVICE, SAME MODEL, WAS OPENED AND PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654014 ↗
• MalfunctionMar 9, 2021Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND STRETCHED. A 5MM X 150MM X 130CM INNOVA SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT DID NOT FULLY DEPLOY IN THE NORMAL MANNER. AS A RESULT, THE STENT WAS DEFORMED AND STRETCHED WHILE REMOVING THE DELIVERY SYSTEM FROM THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449407 ↗
• MalfunctionJan 19, 2021Premature Activation; Premature Activation

  IT WAS REPORTED THAT THE STENT INADVERTENTLY DEPLOYED. A 5MM X 150MM X 130CM INNOVA WAS SELECTED FOR USE IN A LEFT LEG ARTERIOGRAM WITH ANGIOPLASTY AND STENTING PROCEDURE. DURING PREPARATION, THE DEVICE WAS BEING FLUSHED ON THE BACK TABLE WHEN THE STENT PARTIALLY DEPLOYED. THE DEVICE NEVER ENTERED THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11196843 ↗
• InjuryNov 11, 2020Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

  IT WAS REPORTED THE STENT WAS PREMATURELY DEPLOYED. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE 95% STENOSED, SEVERELY CALCIFIED AND NON-TORTUOUS LESION WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATION WAS PERFORMED. A 5 X 150 X 130 INNOVA WAS ADVANCED OVER A 0.035 GUIDEWIRE. THE INNOVA DID NOT TRACK WELL OVER THE GUIDEWIRE. DUE TO SEVERE CALCIFICATION, THE STENT WAS DEPLOYED ABOVE THE DESIRED LOCATION AND THE STENT DID NOT DEPLOY UNIFORMLY. ANOTHER INNOVA STENT WAS USED TO COMPLETE THE PROCEDURE. POST-DILATION WAS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10823149 ↗
• InjuryMar 22, 2019Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND 1/3 OF THE STENT WAS LEFT IN THE PATIENT. A 5X150X130 INNOVA VASCULAR STENT WAS SELECTED FOR A LOWER EXTREMITY RUNOFF PROCEDURE IN THE PATIENT'S TOTALLY OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS OF NORMAL TORTUOSITY AND HEAVILY CALCIFIED. THE LESION WAS APPROACHED CONTRALATERALLY AND WAS PRE-DILATED. THE DEVICE WAS USED WITH AN UNSPECIFIED AMPLATZ GUIDEWIRE AND A NON-BSC SHEATH. WHILE ATTEMPTING TO DEPLOY, THE THUMBWHEEL ONLY WORKED FOR THE FIRST 1/3 OF THE DELIVERY OF THE STENT AND THEN STOPPED DEPLOYING THE STENT. NORMAL FORCE WAS REQUIRED TO TURN THE THUMBWHEEL. THE PULL GRIP WAS ATTEMPTED TO BE USED TO DEPLOY THE STENT, BUT STILL ONLY APPROXIMATELY 1/3 OF THE STENT DEPLOYED IN THE SFA. THE PHYSICIAN BROKE THE STENT TO REMOVE THE WHOLE SYSTEM, BUT LEFT THE 1/3 OF THE STENT INSIDE OF THE PATIENT'S SUBINTIMAL PLANE. THE REST OF THE STENT, THAT WAS REMAINING IN THE SHEATH, WAS REMOVED FROM THE PATIENT. THE CASE WAS FINISHED AT THAT POINT. NO PORTION OF THE FRACTURED STENT WAS STICKING OUT OF THE SUBINTIMAL PLANE TO OBSTRUCT BLOOD FLOW. THE PHYSICIAN CHOSE NOT TO REMOVE THE FRACTURED PORTION BECAUSE IT WAS IN THE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8445254 ↗
• MalfunctionMar 18, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE GREATER THAN 50% STENOSED TARGET LESION WAS LOCATED IN THE NORMALLY TORTUOUS AND HIGHLY CALCIFIED LEFT LOWER EXTREMITY. FOLLOWING PRE-DILATION, A 5 X 150 X 130 INNOVA STENT WAS ADVANCED IPSILATERAL OVER A NON-BSC GUIDEWIRE AND STENT DEPLOYMENT WAS INITIATED. THE THUMBWHEEL WAS USED TO DEPLOY THE STENT. THE THUMBWHEEL WAS ABLE TO DEPLOY 95% OF THE STENT. THE PULL GRIP WAS ATTEMPTED TO DEPLOY THE REMAINING 5% BUT THE PULL GRIP DID NOT WORK. THE PHYSICIAN THEN BACKED THE DELIVERY CATHETER OVER THE WIRE AND THE STENT RELEASED AND WAS ABLE TO DEPLOY. THE STENT DID NOT APPEAR STRETCHED OR ELONGATED. THE STENT WAS DEPLOYED IN THE TARGET LESION. THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430520 ↗
• MalfunctionAug 10, 2018Stretched; Activation, Positioning or Separation Problem; Stretched; Activation, Positioning or Separation Problem

  SAME CASE AS MDR ID: 2134265-2018-07262. IT WAS REPORTED THAT PARTIAL STENT DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED POPLITEAL ARTERY. A 5 X 150 X 130 INNOVA¿ WAS SELECTED FOR USE AND DEPLOYMENT ATTEMPTED. ONLY A PARTIAL AMOUNT OF THE STENT DEPLOYED FROM THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WITH STENT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN CHOSE ANOTHER 5 X 150 X 130 INNOVA¿ AND DEPLOYMENT WAS ATTEMPTED; HOWEVER, THE SAME THING OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY ONLY. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT CONDITION POST-PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7771927 ↗
• MalfunctionAug 10, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS FURTHER REPORTED THAT THE DEPLOYMENT THUMBWHEEL BECAME INCREASINGLY MORE DIFFICULT AS DEPLOYMENT WAS INITIATED. THE PULL GRIP EVENTUALLY DISCONNECTED DUE TO THE HIGH FORCES REQUIRED. THE PATIENT'S CALCIFICATION AND DISEASE WAS DESCRIED AS VERY DIFFICULT AND 'HARD AS A ROCK'. THE PHYSICIAN DID ASSESS THIS AS BEING A FACTOR IN THE PROCEDURE. THE PATIENT WAS CONFIRMED TO BE FINE. NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7771926 ↗
• InjuryJul 3, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED. A 5X150X130 INNOVA¿ STENT WAS SELECTED FOR AN INTERVENTION IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS 90% STENOSED, MINIMALLY TORTUOUS, AND MODERATELY CALCIFIED. ANTEGADE ACCESS WAS GAINED TO THE LESION AND PRE-DILATATION WAS PERFORMED. THERE WAS NO DIFFICULTY DEPLOYING THE STENT, HOWEVER, DURING DEPLOYMENT THE STENT STARTED TO COMPRESS AND IT SHORTENED. THE STENT MEASURED 80 MM POST-DEPLOYMENT (VISUAL ESTIMATION). NO DAMAGE WAS NOTED ON THE STENT. POST-DILATATION WAS PERFORMED AFTER THE STENT WAS DEPLOYED. BECAUSE THE STENT WAS ASSESSED TO BE SHORTENED, A 5X60 INNOVA¿ STENT WAS USED TO COVER THE REST OF THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENTS STATUS AFTER THE PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7660612 ↗
• InjuryMay 22, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR ID: 2134265-2018-04459. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2017, THE INDEX PROCEDURE WAS PERFORMED. THE PATIENT PRESENTED WITH CRITICAL ISCHEMIA, REST PAIN, GANGRENE, NON-HEALING ULCERS, AND AMPUTATION OF TOE. AN ANGIOGRAM OF THE RIGHT LEG SHOWED THAT THE RIGHT POPLITEAL ARTERY WAS 70% STENOSED AND THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS 60% STENOSED. A 5MM BY 150MM INNOVA STENT WAS IMPLANTED IN THE RIGHT POPLITEAL ARTERY AND POST-DILATED WITH A 5MM BY 200MM NON-BSC BALLOON. PRETREATMENT STENOSIS WAS 70% AND POST TREATMENT STENOSIS WAS 0%. A 6MM BY 120MM INNOVA STENT WAS IMPLANTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND POST-DILATED WITH A 6MM BY 150MM NON-BSC BALLOON. PRETREATMENT STENOSIS WAS 60% AND POST TREATMENT STENOSIS WAS 0%. THERE WERE NO COMPLICATIONS AND THERE WAS SIGNIFICANT IMPROVED RUNOFF AND FOOT PERFUSION POST INTERVENTION. ON (B)(6) 2018, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS OF BOTH INNOVA STENTS. ATHERECTOMY WAS PERFORMED USING A BSC JETSTREAM 2.4MM ATHERECTOMY CATHETER, FOLLOWED BY BALLOON ANGIOPLASTY WITH A 5MM BY 150MM BSC STERLING BALLOON. THE VESSELS WERE PATENT POST PROCEDURE. THERE WERE NO PATIENT CO

  Patient problems: Reocclusion

  MAUDE report 7535431 ↗
• InjuryMar 28, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR 2134265-2018-02379 AND MDR 2134265-2018-02377. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. A 6 X 80 INNOVA¿ STENT AND TWO 5 X 150 X 130 INNOVA¿ STENTS WERE SELECTED FOR THE INITIAL PROCEDURE ON (B)(6) 2017. THE PATIENT PRESENTED WITH CRITICAL ISCHEMIA, GANGRENE OF THE TOES AND RESTING PAIN. USING ULTRASOUND, IT WAS NOTED THAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WAS OCCLUDED AND THE RIGHT POPLITEAL ARTERY WAS OCCLUDED. THE RIGHT POPLITEAL ARTERY WAS BALLOON DILATED WITH A 5 X 200 NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 100%. POST-TREATMENT STENOSIS WAS 50% WITH DISSECTION. A 5 X 150 INNOVA STENT WAS PLACED IN THE RIGHT POPLITEAL ARTERY. THE STENT WAS POST DILATED WITH A NON-BSC 5 X 200 BALLOON. POST TREATMENT STENOSIS WAS 0%. THE RIGHT SFA WAS ATHERECTOMIZED WITH A BOSTON SCIENTIFIC JETSTREAM DEVICE. PRE-TREATMENT STENOSIS WAS 100% WITH DISSECTION AND POST-TREATMENT WAS 90%. THE RIGHT SFA WAS BALLOON DILATED WITH A 5 X 200 NON-BSC BALLOON. POST-TREATMENT STENOSIS WAS 50% WITH DISSECTION. A 5 X 150 INNOVA STENT WAS PLACED IN THE DISTAL RIGHT SFA. THE STENT WAS POST DILATED WITH A NON-BSC BALLOON. POST-TREATMENT STENOSIS WAS 0%. A 6 X 80 INNOVA STENT

  Patient problems: Reocclusion

  MAUDE report 7379844 ↗
• InjuryMar 28, 2018Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR 2134265-2018-02378 AND MDR 2134265-2018-02377. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. A 6 X 80 INNOVA¿ STENT AND TWO 5 X 150 X 130 INNOVA¿ STENTS WERE SELECTED FOR THE INITIAL PROCEDURE ON (B)(6) 2017. THE PATIENT PRESENTED WITH CRITICAL ISCHEMIA, GANGRENE OF THE TOES AND RESTING PAIN. USING ULTRASOUND, IT WAS NOTED THAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WAS OCCLUDED AND THE RIGHT POPLITEAL ARTERY WAS OCCLUDED. THE RIGHT POPLITEAL ARTERY WAS BALLOON DILATED WITH A 5 X 200 NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 100%. POST-TREATMENT STENOSIS WAS 50% WITH DISSECTION. A 5 X 150 INNOVA STENT WAS PLACED IN THE RIGHT POPLITEAL ARTERY. THE STENT WAS POST DILATED WITH A NON-BSC 5 X 200 BALLOON. POST TREATMENT STENOSIS WAS 0%. THE RIGHT SFA WAS ATHRECTOMIZED WITH A BOSTON SCIENTIFIC JETSTREAM DEVICE. PRE-TREATMENT STENOSIS WAS 100% WITH DISSECTION AND POST-TREATMENT WAS 90%. THE RIGHT SFA WAS BALLOON DILATED WITH A 5 X 200 NON-BSC BALLOON. POST-TREATMENT STENOSIS WAS 50% WITH DISSECTION. A 5 X 150 INNOVA STENT WAS PLACED IN THE DISTAL RIGHT SFA. THE STENT WAS POST DILATED WITH A NON-BSC BALLOON. POST-TREATMENT STENOSIS WAS 0%. A 6 X 80 INNOVA STENT

  Patient problems: Reocclusion

  MAUDE report 7379838 ↗
• InjuryDec 22, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR 2134265-2017-13134 AND MDR 2134265-2017-13135. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2017, THE INDEX PROCEDURE WAS PERFORMED. THE PATIENT PRESENTED WITH CRITICAL ISCHEMIA, GANGRENE OF THE TOES AND RESTING PAIN THE RIGHT LEG. AN ANGIOGRAM OF THE RIGHT POPLITEAL ARTERY SHOWED THAT IT WAS OCCLUDED. AN ANGIOGRAM OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) SHOWED IT WAS OCCLUDED. A 5X150 INNOVA¿ STENT WAS PLACED IN THE RIGHT POPLITEAL ARTERY. THE STENT WAS POST-DILATED WITH A NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 50% AND POST-TREATMENT STENOSIS WAS 0%. A 5X150 INNOVA¿ STENT WAS PLACED IN THE DISTAL RIGHT SFA. THE STENT WAS POST-DILATED WITH A NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 50% AND POST-TREATMENT WAS 0%. A 6X80 INNOVA¿ STENT WAS PLACED IN THE PROXIMAL RIGHT SFA. THE STENT WAS POST-DILATED WITH A NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 50% AND POST-TREATMENT WAS 0%. THE PROCEDURE HAD EXCELLENT RESULTS WITH PALPABLE PULSES POST INTERVENTION. THE PATIENT CONDITION WAS STABLE. ON (B)(6) 2017, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS IN BOTH 5X150 INNOVA¿ STENTS AND THE 6X80 INNOVA¿ STENT. AN ANGIOGRAM SHOWED THE RIGHT SFA

  Patient problems: Reocclusion

  MAUDE report 7142765 ↗
• InjuryDec 22, 2017Occlusion Within Device; Occlusion Within Device

  SAME CASE AS MDR 2134265-2017-13134 AND MDR 2134265-2017-13136. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. ON (B)(6) 2017, THE INDEX PROCEDURE WAS PERFORMED. THE PATIENT PRESENTED WITH CRITICAL ISCHEMIA, GANGRENE OF THE TOES AND RESTING PAIN THE RIGHT LEG. AN ANGIOGRAM OF THE RIGHT POPLITEAL ARTERY SHOWED THAT IT WAS OCCLUDED. AN ANGIOGRAM OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) SHOWED IT WAS OCCLUDED. A 5X150 INNOVA¿ STENT WAS PLACED IN THE RIGHT POPLITEAL ARTERY. THE STENT WAS POST-DILATED WITH A NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 50% AND POST-TREATMENT STENOSIS WAS 0%. A 5X150 INNOVA¿ STENT WAS PLACED IN THE DISTAL RIGHT SFA. THE STENT WAS POST-DILATED WITH A NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 50% AND POST-TREATMENT WAS 0%. A 6X80 INNOVA¿ STENT WAS PLACED IN THE PROXIMAL RIGHT SFA. THE STENT WAS POST-DILATED WITH A NON-BSC BALLOON. PRE-TREATMENT STENOSIS WAS 50% AND POST-TREATMENT WAS 0%. THE PROCEDURE HAD EXCELLENT RESULTS WITH PALPABLE PULSES POST INTERVENTION. THE PATIENT CONDITION WAS STABLE. ON (B)(6) 2017, THE PATIENT PRESENTED WITH IN-STENT RESTENOSIS IN BOTH 5X150 INNOVA¿ STENTS AND THE 6X80 INNOVA¿ STENT. AN ANGIOGRAM SHOWED THE RIGHT SFA

  Patient problems: Reocclusion

  MAUDE report 7142764 ↗

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