SpiderFX™ SPD2-US-050-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00821684068342), received between Dec 21, 2016 and Apr 22, 2026 — classified as 28 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (29 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A SPIDER FX DEVICE HAD A SPIDER COMPONENT DETACH WITHIN THE SHEATH WHILE THE DEVICE WAS BEING REMOVED AS THE PROCEDURE WAS REACHING COMPLETION. THE DETACHED SPIDER COMPONENT WAS REMOVED WITHIN THE SHEATH, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24950919 ↗
• InjuryApr 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY INTERVENTION USING THE SPIDER FX EMBOLIC PROTECTION DEVICE IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY, THE BASKET COMPONENT DETACHED WITHIN THE SHEATH. THE TARGET LESION WAS DESCRIBED AS PLAQUE WITH MINIMAL TORTUOSITY, MODERATE CALCIFICATION, CHRONIC TOTAL OCCLUSION, A LESION LENGTH OF 200 MM, AND A VESSEL DIAMETER OF 6 MM. A 7FR NON MEDTRONIC SHEATH WAS USED, EMBOLIC PROTECTION WAS USED, THE VESSEL WAS NOT PRE-DILATED, AND THE VESSEL WAS POST-DILATED WITH AN EVERCROSS 5X150 DEVICE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, THERE WAS NO REPORTED PACKAGING DAMAGE OR ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY, AND THE INSTRUCTIONS FOR USE WERE REPORTEDLY FOLLOWED WITHOUT ISSUE. A CUT-DOWN WAS PERFORMED TO REMOVE THE DETACHED BASKET, THE DEVICE WAS REPORTEDLY SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24938319 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF PERIPHERAL ARTERY PLAQUE IN THE MID RIGHT TIBIAL/POPLITEAL TRUNK, THE SPIDER FX DEVICE WIRE BROKE AT THE BREAK POINT INTO THE CXI CATHETER. THE RETRIEVAL CATHETER PROVIDED WITH THE SPIDER DEVICE WAS USED TO CAPTURE THE BROKEN SPIDER DEVICE, AND A NEWLY OPENED SPIDER DEVICE WAS DEPLOYED WITHOUT ISSUE. THE VESSEL HAD MINIMAL TORTUOSITY AND CALCIFICATION, WITH A DIAMETER OF 4 MM. THE SHEATH USED WAS A 6FR TERUMO PINNACLE, AND POST-DILATION WAS PERFORMED WITH A BOSTON STERLING DEVICE. THERE WERE NO ABNORMALITIES IN ANATOMY, NO RESISTANCE ENCOUNTERED, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC SPIDER DEVICE. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590231 ↗
• MalfunctionFeb 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING RETRIEVAL, THE WIRE OF THE EP SPD2-US-050-320 SPIDER FX WAS CUT INSIDE THE GUIDING CATHETER. IT IS NOT KNOWN HOW THE DETACHED COMPONENT WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290308 ↗
• InjuryFeb 4, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE EP SPD2-US-050-320 SPIDER FX DEVICE, A PATIENT EXPERIENCED A 30-MINUTE DELAY IN SURGERY DUE TO A PRODUCT MALFUNCTION. THE PROCEDURE TARGETED A 100% STENOSED LESION WITH PLAQUE LOCATED IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, WITH A LESION LENGTH OF 200MM AND ARTERY DIAMETER OF 7MM. MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. A 7X40 NON-MEDTRONIC SHEATH WAS USED. THE VESSEL WAS POST-DILATED WITH A 6X80 EVERCROSS PTA BALLOON. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. REMOVAL DIFFICULTIES WERE ENCOUNTERED WHEN RETRIEVING THE DEVICE. THE DISTAL PART OF SPIDER DETACHED AND REMAINS OF THE PRODUCT WERE LEFT ON THE STENT. THE DEPLOYED STENT WAS ALTERED AND CORRECTED BY STENT OVERLAP AND PTA. THE RESIDUAL MATERIAL/ENDO-TRASH WAS STENTED OVER AND THE PROCEDURE WAS COMPLETED. NO VESSEL DAMAGE REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258180 ↗
• InjuryMar 27, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A SPIDER FX DEVICE, DEFORMATION OCCURRED IN VIVO WHERE THE SPIDER WAS NOT FULLY OPEN AND NOT COMPLETELY OPPOSED TO THE VESSEL WALL. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY REPORTED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE, WITHOUT ISSUE. THE LESION WAS LOCATED IN THE RIGHT COMMON CAROTID ARTERY, PROXIMAL LOCATION, WITH AN 80% STENOSIS AND A LENGTH OF 25MM. THE ARTERY DIAMETER WAS 4.85MM, AND THE LESION WAS MINIMALLY CALCIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE PATIENT EXPERIENCED A RIGHT HEMISPHERIC STROKE REQUIRING REHABILITATION. THE STROKE WAS ASSOCIATED WITH THE PRODUCT ISSUE. THE ADVERSE OUTCOMES INCLUDED HOSPITALIZATION WITH PROLONGATION OF THE EXISTING STAY, EXTENDED STAY POST-PROCEDURE, AND DISABILITY. THE ISSUE IS STILL PRESENT.

  Patient problems: Stroke/CVA

  MAUDE report 21709633 ↗
• MalfunctionJan 7, 2025Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT AN ATTEMPTED WAS MADE TO USE A SPIDER FX EMBOLIC PROTECTION DEVICE IN A PATIENT TO TREAT A CALCIFIED FIBROUS PLAQUE RIGHT MID INTERNAL CAROTID ARTERY WITH SEVERE TORTUOSITY. A NON-MEDTRONIC SHEATH WAS USED AND A NON-MEDTRONIC GUIDEWIRE. MODERATE RESISTANCE WAS NOTED AND IFU WAS FOLLOWED. IT WAS REPORTED THAT THE DISTAL TIP OF THE SPIDER WIRE DETACHED AFTER REMOVAL OF THE DEVICE DUE TO TRACKING DIFFICULTIES DUE TO ANATOMY. THE DETACHED COMPONENT WAS REMOVED, DEVICE DID NOT DETACH UNTIL REMOVED FROM THE BODY AND THE PHYSICIAN BARELY TOUCHED IT. PROCEEDED WITH CAROTID STENTING WITHOUT THE USE OF AN EMBOLIC PROTECTION DEVICE. THE DEVICE WAS PREPPED AS NORMAL WITH NO ISSUE. PHYSICIAN IS VERY EXPERIENCED WITH SPIDER FX. PATIENT PRESENTED WITH TORTUOUS ANATOMY CAUSING THE SPIDER TO NOT TRACK WELL INTO THE INTERNAL CAROTID ARTERY. WHEN ADVANCING THE SPIDER THROUGH THE INTRODUCER SHEATH, WE NOTICED THE WIRE BUCKLING ON ITSELF A LITTLE BIT AND THE PHYSICIAN FELT RESISTANCE WHEN TRYING TO ADVANCE. WE REMOVED THE DEVICE AND INSPECTED IT. THE PHYSICIAN SAID HE JUST BARELY TOUCHED THE TIP OF THE WIRE, AND IT BROKE RIGHT OFF, DELAYS IN SURGERY DUE TO PRODUCT MALFUNCTION FOR 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091172 ↗
• InjuryJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A SPIDER FX, THE BASKET COMPONENT DETACHED AT THE TARGET LESION IN THE LEFT COMMON CAROTID ARTERY, MID-LOCATION. THE TARGET LESION WAS PLAQUE, AND THE DEGREE OF TORTUOSITY WAS MODERATE WITH MINIMAL CALCIFICATION. THE DETACHED COMPONENT WAS SUCCESSFULLY REMOVED USING A NON MEDTRONIC FORCEPS. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, WHICH WAS NOT A MEDTRONIC DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21077108 ↗
• MalfunctionOct 16, 2024Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A SPIDER FX TO TREAT A LESION. DEVICE WOULD NOT DEPLOY. IT WAS REPORTED THAT THE DEVICE WAS AN EXPIRED PRODUCT. DEVICE SAFELY REMOVED FROM PATIENT. PROCEDURE COMPLETED BY USING A NEW DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459097 ↗
• InjuryJan 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A SPIDER FX TO TREAT A CALCIFIED LESION IN THE RIGHT MID POPLITEAL ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS SEVERE. A 6FR FORTRESS WAS USED. A 014 NITREX N143001 WAS USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. IFU WAS FOLLOWED. THERE WAS ISSUE LOADING INTO THE DELIVERY CATHETER. SUPPLIED RECOVERY CATHETER WAS USED. THERE WAS DIFFICULTIES DURING PLACEMENT OF CATHETER. THERE WAS RESISTANCE. THE TIP DETACHED. CATHETER WAS ADVANCED PER PHYSICIAN AND GOT HUNG UP WHEN REPOSITIONING, THE RETRIEVAL CATHETER GOT STUCK AND TIP BROKE OFF. PHYSICIAN WAS ABLE TO SNARE. TIP DETACHMENT DID NOT RESULT IN INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18543783 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A SPIDER FX EMBOLIC PROTECTION DEVICE WITH A 6FR SHEATH AND A NON-MEDTRONIC (TERUMO) GUIDEWIRE DURING TREATMENT OF A 40MM CALCIFIED LESION IN THE PATIENT¿S LEFT MID COMMON CAROTID ARTERY. LITTLE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. ARTERY DIAMETER REPORTED AS 8MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE INTERNAL CAROTID WAS STENTED USING AN 8X40 NON-MEDTRONIC STENT. THE STENT WAS POST DILATED WITH A 6X20 NON-MEDTRONIC BALLOON. PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS AND POST PROCEDURE IMAGING WAS OBTAINED AND NOTHING WAS NOTICEABLE. PATIENT WENT TO POST-OP AND WAS UNAROUSABLE AND DEMONSTRATED RIGHT SIDE PARALYSIS 2 DAYS LATER. IT IS UNKNOWN IF STROKE WAS EMBOLIC. THE PHYSICIAN WAS NOT SURE IF THE EVENT WAS RELATED TO THE DEVICE OR PROCEDURE, A FOLLOW UP MRI WAS NOT AVAILABLE DUE TO A SPINAL CORD STIMULATOR.

  Patient problems: Stroke/CVA

  MAUDE report 18310618 ↗
• MalfunctionJun 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE WITH A 45CM 7FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A 200MM LESION IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY. MODERATE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 85% STENOSIS. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT IS REPORTED THE SPIDER FILTER BROKE WHEN THE PHYSICIAN WAS ADVANCING IT INTO THE PATIENT THROUGH A .035 X 150 TRAILBLAZER WITH MINIMAL FORCE. THE SPIDER DID NOT PROLAPSE WITHIN THE DELIVERY CATHETER AND DID NOT APPEAR TO BE DEFORMED ON INSPECTION. THE FILTER DID NOT DETACH, THE WIRE BROKE INTO TWO DIFFERENT PIECES. THE PORTION OF THE WIRE THAT WAS INSIDE THE PATIENT WAS EASILY AND SAFELY REMOVED FROM THE PATIENT USING HANDS THROUGH THE TRAILBLAZER AND WAS REPLACED BY A NEW 5.0 SPIDER FILTER TO COMPLETE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226364 ↗
• InjuryJun 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A SPIDER FX DURING TREATMENT OF A CALCIFIED LESION IN THE COMMON CAROTID ARTERY (CCA). THERE WAS MODERATE TORTUOSITY AND CALCIFICATION. THE IFU WAS FOLLOWED. IT WAS REPORTED PART OF THE PRIMARY  GUIDEWIRE EXIT PORT WAS SNAPPED AND LEFT AT THE CCA. A SNARE WAS USED TO CAPTURED THE LEFT PART OF THE CATHETER AND TOOK OUT IT. ANOTHER GUIDEWIRE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 17125376 ↗
• InjuryJun 2, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A SPIDERFX TO TREAT A FIBROUS LESION IN THE MID SHORT SAPHENOUS VEIN (SSV). DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS LITTLE. LESION STENOSIS WAS CTO (CHRONIC TOTAL OCCLUSION-100%). A 6FR SHEATH FRENCH WAS USED. 5MM EMBOLIC PROTECTION WAS USED. THE VESSEL WAS PRE-DILATED. THE VESSEL WAS POST-DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE FILTER DETACHED. PHYSICIAN CROSSED LESION, PLACED IVUS (INTRAVASCULAR ULTRASOUND) OVER SPIDER WIRE, WHILE REMOVING IVUS CATHETER THEY REALIZED THE SPIDER WIRE BROKE. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE FILTER WITHOUT SUCCESS. PHYSICIAN DECIDED TO LEAVE IT, DUE TO THE GRAFT BEING OCCLUDED. THE PATIENT IS ALIVE WITH NO COMPLICATIONS AS A RESULT OF SPIDER BREAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049197 ↗
• MalfunctionMay 17, 2023Difficult to Remove; Difficult to Advance; Device Contamination with Chemical or Other Material; Material Deformation; Difficult to Remove; Difficult to Advance; Device Contamination with Chemical or Other Material; Material Deformation

  A SPIDER FX WAS BEING USED DURING THE TREATMENT OF A PLAQUE LESION IN THE PROXIMAL REGION OF THE POPLITEAL ARTERY. THERE WAS MILD TORTUOSITY AND CALCIFICATION. THE ARTERY DIAMETER WAS 5MM. THE IFU WAS FOLLOWED. THE VESSEL WAS NOT PRE-DILATED.  IT WAS REPORTED THE PHYSICIAN ATTEMPTED TO PUSH THE SPIDER THROUGH A A .035 STRAIGHT TRAILBLAZER BUT ENCOUNTERED MILD RESISTANCE WHILE PUSHING. THE SHEATH POSITION WAS CHECKED TO ENSURE NO KINKING OR PROLAPSING INTO AORTA. THE PHYSICIAN SUCCESSFULLY PUSHED THE SPIDER THROUGH THE TRAILBLAZER AND LANDED IT BELOW TWO LESIONS. A HAWKONE M WAS USED TO SHAVE THE PROXIMAL LESION AND THEN WANTED TO ADVANCE THE HAWK TO THE DISTAL LESION. THE SPIDER BASKET CAME BACK AS THE HAWK WAS ADVANCING DOWN AND WOULD NOT PUSH FORWARD. THE HAWK WAS REMOVED AND THE TRAILBLAZER WAS LOADED ON THE SPIDER WIRE. IT WAS ADVANCED DOWN TO THE SPIDER BUT THE SPIDER WOULD NOT MOVE NEITHER FORWARD NOR BACKWARD AFTER ATTEMPTS WERE MADE TO PUSH IT OR DIRECT IT WITH THE USE OF A TRAILBLAZER. THE MOUTH OF THE SPIDER WAS CAPTURED IN THE TIP OF THE TRAILBLAZER AND THE WHOLE SYSTEM OF CATHETER AND FILTER WAS REMOVED IN TANDEM BECAUSE THE SPIDER WOULD NOT PULL THROUGH THE TRAILBLAZER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945690 ↗
• InjuryFeb 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A SPIDER FX DURING THE TREATMENT OF A PLAQUE/SOFT TISSUE LESION WITH CHRONIC TOTAL OCCLUSION IN THE LEFT POPLITEAL ARTERY. A 6FR NON MEDTRONIC SHEATH WAS USED. AFTER TREATMENT THE SPIDER WAS CAPTURED BY A NON-MEDTRONIC .035 90CM STRAIGHT CATHETER. AS THE DEVICE WAS BEING PULLED OUT AS ONE UNIT THE BASKET AND DISTAL PORTION OF THE WIRE RELEASED FROM THE CATHETER. THE WIRE APPEARED TO HAVE SNAPPED PROXIMAL TO THE BASKET DURING THE CAPTURE PROCESS AND WAS SITTING IN THE DISTAL POPLITEAL. THE SHEATH WAS EXCHANGED FOR A 6F 90CM NON-MEDTRONIC SHEATH. A 6-12MM NON-MEDTRONIC SNARE WITH A 120 CATHETER KIT WAS USED TO SNARE THE DEVICE INTO THE CATHETER AND SHEATH AND OUT OF THE PATIENT. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16450073 ↗
• InjuryFeb 9, 2023Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  A TURBOHAWK PLUS AND A SPIDER FX WERE BEING USED FOR THE TREATMENT OF A 60MM PLAQUE LESION IN THE DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. THE ARTERY DIAMETER WAS 5MM IN AND THE DEGREE OF TORTUOSITY WAS MODERATE. THERE WAS MILD CALCIFICATION. A 6FR NON MEDTRONIC SHEATH WAS USED FOR THECASE. THE VESSEL WAS NOT PRE DILATED. BOTH DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE SPIDER FILTER WAS PLACED IN POSTERIOR TIBIAL ARTERY. DEVICE ADVANCED THROUGH LESION AND SEVERAL PASSES PERFORMED WITHOUT INCIDENT. THE TURBOHAWK WAS GOING TO BE REMOVED FROM THE SHEATH BUT RESISTANCE WAS FELT. A WIRE LOOP WAS DISCOVERED UNDER X-RAY AND THE SPIDER WIRE HAD KINKED. ATTEMPTING TO PULL THE SHEATH, TURBOHAWK AND SPIDER BACK OVER THE AORTIC BIFURCATION RESULTED IN THE HAWK TIP DETACHING. A BUDDY WIRE WAS PLACED ALONGSIDE THE SPIDER WIRE TO MAINTAIN UP-AND-OVER ACCESS. THE TURBOHAWK CATHETER WAS REMOVED WHILE THE SPIDER WIRE REMAINED IN PLACE WITH THE HAWK TIP FLOATING ON IT. THE SHEATH, HAWK TIP, AND SPIDER WIRE WERE ATTEMPTED TO BE REMOVED OVER THE BUDDY WIRE. THE SHEATH CAME OUT BUT THE SPIDER WIRE BROKE AT THE GROIN SITE. THE TUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335970 ↗
• MalfunctionJan 3, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  A PHYSICIAN WAS ATTEMPTING TO USE A SPIDER FX. THE IFU WAS FOLLOWED. IT WAS REPORTED THAT THERE WAS PARTIAL DAMAGE TO THE DISTAL PART OF THE CATHETER DURING THE IFU FOLLOWED PROCEDURE. THE PHYSICIAN DECIDED TO USE ANOTHER PRODUCT TO COMPLETE THE CASE. THE DEVICE WAS PASSED IT EXPIRY DATE WHEN USED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085899 ↗
• InjuryOct 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A SPIDER FX EMBOLIC PROTECTION DEVICE IN THE SUPERFICIAL FEMORAL AND ARTERY POPLITEAL ARTERY. THE IFU WAS FOLLOWED. IT WAS REPORTED WHEN  ATTEMPTING TO RETRIEVE THE FILTER WIRE WITH THE RETRIEVAL SHEATH, THE BASKET OF THE FILTER WIRE BROKE OFF FROM THE PROXIMAL RADIOPAQUE TIP AND REMAINED IN THE PATIENT. A SNARE WAS USED TO RETRIEVE THE BASKET FROM THE VESSEL SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614554 ↗
• InjurySep 14, 2022Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  DURING PROCEDURE, IN THE PROCESS OF PERFORMING LHC (LEFT HEART CATHETERIZATION) ANGIOGRAM THE PHYSICIAN PROCEEDED TO FIX THE STENOSIS OF THE SVG-OM GRAFT. THEY USED A 5.0 SPIDER FILTER WIRE AND THEN PROCEEDED TO PUT A 4.0X12 IN THE OSTIUM OF THE SVG (SAPHENOUS VEIN) GRAFT. THE STENT WAS DEPLOYED SUCCESSFULLY AND IT WAS TIME TO RETRIEVE THE FILTER WIRE WITH THE FILTER REMOVAL SYSTEM THAT COMES WITH THE SPIDER WIRE, THE FILTER WIRE THEN GOT STUCK WITHIN THE STENT. THE PATIENT WAS STABLE THE ENTIRE TIME. THEY THEN HAD TO PROCEED WITH DIFFERENT TECHNIQUES TO GET THE SPIDER FILTER OUT. WE ENDED UP PULLING THE FILTER WIRE OUT WITH THE STENT ATTACHED. VISUALIZED STENT ON FILTER AFTER REMOVAL. NEW STENT PLACE- NO HARM TO PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15416668 ↗
• MalfunctionAug 26, 2022Difficult to Remove; Physical Resistance/Sticking

  IN PROCESS OF PERFORMING THE LHC (LEFT HEART CATHETERIZATION) ANGIOGRAM. WE PROCEEDED TO FIX THE STENOSIS OF THE SVG-OM GRAFT. WE PUT A 5.0 SPIDER FILTER WIRE (MEDTRONIC) AND THEN PROCEEDED TO PUT A 4.0X12 IN THE OSTIUM OF THE SVG (SAPHENOUS VEIN) GRAFT. THE STENT WAS DEPLOYED SUCCESSFULLY, AND IT WAS TIME TO RETRIEVE THE FILTER WIRE WITH THE FILTER REMOVAL SYSTEM THAT COMES WITH THE SPIDER WIRE. THE FILTER WIRE THEN GOT STUCK WITHIN THE STENT. THE PATIENT WAS STABLE THE ENTIRE TIME. WE THEN HAD TO PROCEED WITH DIFFERENT TECHNIQUES TO GET THE SPIDER FILTER OUT. WE ENDED UP PULLING THE FILTER WIRE OUT WITH THE STENT ATTACHED. VISUALIZED STENT ON FILTER AFTER REMOVAL. NEW STENT PLACE- NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15301678 ↗
• InjuryAug 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A 5 MM SPIDER FX EMBOLIC PROTECTION DEVICE ALONG WITH A NON-MEDTRONIC SHEATH DURING TREATMENT OF A CALCIFIED PLAQUE LESION IN THE PATIENT¿S COMMON CAROTID ARTERY. MODERATE VESSEL CALCIFICATION WAS REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. IT IS REPORTED THAT WHEN PHYSICIAN WAS TRYING TO DEPLOY THE FILTER, FILTER PORTION DETACHED FROM THE WIRE. IT WAS A STROKE PATIENT AND NO BLOOD WAS FLOWING SO FILTER STAYED IN PLACE AND DID NOT MIGRATE. ANOTHER FILTER WAS USED TO RETRIEVE THE DETACHED FILTER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209268 ↗
• MalfunctionAug 9, 2022Break

  WHILE DEPLOYING THE SPIDER WIRE, THE TIP OF THE WIRE BROKE OFF IN THE CAROTID.

  Patient problems: Foreign Body In Patient

  MAUDE report 15190464 ↗
• MalfunctionApr 20, 2022Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE THE SPIDER FX EMBOLIC PROTECTION DEVICE DURING PROCEDURE TO TREAT MODERATELY CALCIFIED PLAQUE IN THE DISTAL LEFT POPLITEAL ARTERY. THE VESSEL HAD LITTLE TORTUOSITY AND EXHIBITED 80% STENOSIS. THE ARTERY DIAMETER WAS 4MM AND LESION LENGTH WAS 80MM.A NON MEDTRONIC 6FR SHEATH WAS USED. THE VESSEL WAS PRE AND POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE FILTER WIRE BROKE AT THE BREAKING POINT WHEN A BALLOON WAS BEING LOADED ONTO THE WIRE. THE WIRE WAS NOT BENT AT THE BREAKING POINT AND BROKE ON IT¿S OWN, UNINTENTIONALLY. A NEW FILTER WIRE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14158617 ↗
• InjuryMar 31, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE SPIDERFX EMBOLIC PROTECTION DEVICE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED, NON TORTUOUS PLAQUE LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). LESION PRESENTING WITH 70% STENOSIS. THE VESSEL WAS PRE-DILATED. THE VESSEL WAS POST-DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT FILTER BROKE OFF THE WIRE DURING RETRIEVAL. A 10MM SNARE WAS USED TO RETRIEVE THE DETACHED FILTER FROM THE COMMON FEMORAL ARTERY. DID NOT LEAD TO INJURY FOR PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13965210 ↗