SpiderFX™ SPD2-US-070-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00821684068380), received between Feb 22, 2018 and Mar 13, 2026 — classified as 18 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Deformation Due to Compressive Stress; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE TREATMENT OF A PLAQUE LESION IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY USING THE SPIDER FX EMBOLIC PROTECTION DEVICE, A KINK WAS NOTED AT THE MID WIRE DURING THE PROCEDURE AND THE WIRE SNAPPED ALONG THE BREAK POINT, WHICH APPEARED TO BE DUE TO PHYSICIAN MISHANDLING. IT DID NOT HAVE AN IMPACT ON PATIENT TREATMENT. ARTERY DIAMETER REPORTED AS 6MM. THE VESSEL WAS POST-DILATED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW NON-MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594316 ↗
• InjuryDec 19, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL VASCULAR INTERVENTION USING THE SPIDERFX FILTER, SEVERE CALCIFICATION, AND >75% STENOSIS OF A 60MM LESION IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY/PROXIMAL POPLITEAL ARTERY, THE PHYSICIAN EXPERIENCED DIFFICULTY FULLY COLLAPSING AND CAPTURING THE SPIDERFX FILTER INTO A TRAILBLAZER CATHETER AFTER LESION TREATMENT. THE DEVICE HAD PASSED THROUGH A PREVIOUSLY DEPLOYED PROTEGE EVERFLEX. A NANOCROSS WAS USED FOR POST-DILATION. THE TRAILBLAZER CATHETER BECAME CAUGHT ON THE DISTAL END OF A 7FR NON MEDTRONIC SHEATH PARKED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY AND COULD NOT BE PULLED THROUGH. AN ATTEMPT WAS MADE TO MAINTAIN VESSEL ACCESS WITH A 0.035" STIFF ANGLED GLIDEWIRE AND TO REPLACE THE SHEATH, BUT UPON REMOVAL, THE SPIDERFX FILTER BECAME CAUGHT AT THE LEFT COMMON FEMORAL ARTERIOTOMY SITE AND COULD NOT BE RETRIEVED. FURTHER ATTEMPTS TO RECAPTURE THE FILTER RESULTED IN THE FILTER SNAPPING OFF THE WIRE AND REMAINING WITHIN THE PATIENT'S SOFT TISSUES. SURGICAL CUTDOWN ON THE LEFT GROIN WAS REQUIRED TO RETRIEVE THE FILTER, AND CONTRALATERAL GROIN ACCESS WAS OBTAINED TO PLACE A COVERED STENT AT THE LEFT COMMON FEMORAL ARTERIOTOMY SITE. POST

  Patient problems: Insufficient Information

  MAUDE report 23851467 ↗
• InjuryDec 14, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A EP SPD2-US-070-320 SPIDER FX TO TREAT A CALCIFIED FIBROUS LESION IN THE LEFT PROXIMAL MID DISTAL COMMON FEMORAL ARTERY, EXTERNAL ILIAC ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS MODERATE. LESION LENGTH WAS 60MM. ARTERY/VEIN DIAMETER WAS 9MM. LESION LOCATION WAS A FORMER SURGICAL SITE, ARTERIOTOMY. A 8 DESTINATION SHEATH WAS USED. DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED MEDTRONIC GPS. SEVERE RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE USED. BUDDY WIRE WAS PLACED WITH SPIDER PRIOR TO REMOVAL AND SPIDER WAS PULLED INTO SHEATH WITH INTENT TO REMOVE WITH THE SHEATH, BUT THE WRONG WIRE WAS PULLED AND THE SPIDER REMAINED. SPIDER BASKET DETACHED WITHIN THE VESSEL WHEN FORCED TO PULL. TACKED TO VESSEL WALL. REMAINS IMPLANTED IN PATIENT WITH COVERED STENT SECURING ITS LOCATION. UNABLE TO RETRIEVE WITH SNARE OR BIOPSY FORCEPS.

  Patient problems: Insufficient Information

  MAUDE report 23799513 ↗
• InjuryAug 29, 2025Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (MODERATE CALCIFICATION, 60MM LESION LENGTH, 7MM ARTERY DIAMETER) WITH THE SPIDER FX, THE SPIDER BASKET/FILTER DETACHED FROM THE WIRE WITHIN THE SHEATH. A TIGHT FIT WAS NOTED ONCE THE SPIDER BASKET ENTERED THE SHEATH. THE DETACHED BASKET/FILTER WAS SNARED AND SAFELY REMOVED. THE PROCEDURE WAS COMPLETED AT THE END OF THE CASE AFTER REMOVAL OF THE FILTER BASKET FROM THE PATIENT'S SUPERFICIAL FEMORAL ARTERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22920915 ↗
• InjuryJul 2, 2025Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SPIDER FX AND THE STENT PROTEGE RX, A PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO COMPLICATIONS ENCOUNTERED IN THE LEFT DISTAL COMMON CAROTID ARTERY, WHICH HAD AN 80% STENOTIC PLAQUE AT THE TARGET LESION. THE PATIENT¿S VASCULAR ANATOMY WAS DESCRIBED AS SEVERELY TORTUOUS, INCLUDING ARCH ANATOMY TORTUOSITY AND A TORTUOUS INTERNAL CAROTID ARTERY. DURING THE PROCEDURE, THE SPIDER FX FILTER BECAME ENTRAPPED WITHIN THE STENT AND COULD NOT BE REMOVED ENDOVASCULARLY. THIS RESULTED IN REMOVAL DIFFICULTIES, REQUIRING A SURGICAL CUTDOWN FOR DEVICE RETRIEVAL. THE PATIENT WAS SUBSEQUENTLY TAKEN TO SURGERY FOR STENT AND SPIDER FX REMOVAL VIA CAROTID ENDARTERECTOMY. VESSEL DAMAGE WAS NOTED AS A CUTDOWN WAS PERFORMED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE THAT WAS NOT A MEDTRONIC PRODUCT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22385625 ↗
• InjuryOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A SPIDER FX WAS PLACED PRIOR TO ATHERECTOMY. AFTER THE ATHERECTOMY WAS COMPLETE THE RETRIEVAL CATHETER WAS INSERTED OVER THE FILTER WIRE AND FILTER TIP WAS CAPTURED WITHIN THE CATHETER. AS THE CATHETER AND WIRE WERE BEING PULLED UP, THE RETRIEVAL CATHETER SNAPPED OFF THE WIRE AND WAS LEFT INSIDE THE PATIENT. A 5MM SNARE WAS DEPLOYED OVER THE FILTER WIRE AND SUCCESSFULLY CAPTURED THE PORTION OF THE CATHETER LEFT IN THE PATIENT. THE CATHETER WOULD NOT PASS THROUGH THE SHEATH SO THE PROCEDURE ENDED EARLY.

  Patient problems: Insufficient Information

  MAUDE report 20383116 ↗
• MalfunctionNov 8, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A SPIDER FX DURING TREATMENT OF A LESION IN THE LEFT PROXIMAL REGION OF THE LESION/VESSEL SITE OR LOCATION ASSOCIATED WITH THE EVENT SUPERFICIAL FEMORAL ARTERY (SFA). A 7FR NON MEDTRONIC SHEATH WAS USED. THE IFU WAS FOLLOWED. IT WAS REPORTED THE PATIENT HAD LEFT GROIN ACCESSED FOR A RIGHT SFA INTERVENTION. A 7MM SPIDER AND 7F TURBOHAWK-LX WERE USED TO SHAVE THE SFA. THE SFA WAS HIGHLY CALCIFIED AND THE FILTER BASKET WAS NOTED TO BE FULL OF DEBRIS. UPON TRYING TO CAPTURE THE SPIDER, IT WAS TOO FULL TO RETRIEVE THROUGH A CATHETER, SO THE TRAILBLAZER <(>&<)> SPIDER WERE PULLED BACK TO THE SHEATH BUT THE SPIDER WAS TOO FULL TO PULL INTO THE 7F SHEATH. THE PHYSICIAN PULLED EVERYTHING BACK UP OVER THE GROIN, ADVANCED A SECOND WIRE THROUGH THE SHEATH TO MAINTAIN ACCESS AND TRIED TO WITHDRAW THE 7F SHEATH AND PUT IN AN 8F SHEATH. THE FILTER STILL WOULDN¿T PULL THROUGH THE SHEATH AND AFTER TUGGING, THE BASKET BROKE IN THE GROIN. ANGIO SHOWED IT APPEARED TO BE IN THE ARTERIOTOMY ITSELF. THE PROCEDURE WAS TERMINATED AND THE PA TIENT RECOVERED WITHOUT INCIDENT. THE PHYSICIAN STATED THAT THE PATIENT RECENTLY GOT A GROIN DUPLEX STUDY AND HAS NO COMPLICATIONS FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091538 ↗
• InjuryJun 2, 2023Peeled/Delaminated; Difficult to Remove; Peeled/Delaminated; Difficult to Remove

  A SPIDER FX WAS BEING USED FOR TREATMENT OF TWO CALCIFIED LESIONS WITH 80% STENOSIS, ONE 60MM LESION IN PROXIMAL REGION AND A 40MM LESION IN THE DISTAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. A 7FR NON MEDTRONIC SHEATH WAS USED. THE VESSEL WAS NOT PRE-DILATED. THE IFU WAS FOLLOWED. IT WAS REPORTED COMPONENT EMBOLIZATION OCCURRED DURING WITHDRAWAL WITHIN THE VESSEL. A NON-MEDTRONIC ATHERECTOMY DEVICE WAS USED OVER THE SPIDER FX. AFTER THE ATHERECTOMY WITH THE NON-MEDTRONIC ATHERECTOMY DEVICE, THE PHYSICIAN ATTEMPTED TO REMOVE THE FILTER, BUT THE RETRIEVAL CATHETER WOULD NOT FIT OVER THE BASKET. THEY CAPTURED THE FILTER WITH THE SHEATH AND PULLED THE SYSTEM OUT OF THE BODY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THERE WAS NO VESSEL DAMAGE. UPON INSPECTION, IT WAS NOTED THAT SOMETHING EMBOLIZED AROUND THE WIRE AND COULD NOT BE REMOVED FROM THE SPIDER WIRE, IT IS THOUGHT TO BE THE COATING ON THE WIRE. THE PATIENT'S LEFT POSTERIOR TIBIAL EMBOLIZED. I NTRA-ARTERIAL NITRO WAS GIVEN AND THE VESSEL RESOLVED TO PATENT FLOW.

  Patient problems: Reduced Blood Flow

  MAUDE report 17048230 ↗
• InjuryFeb 16, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  A PHYSICIAN WAS USING A SPIDER FX DURING TREATMENT OF A 40-60MM CALCIFIED LESION WITH 80% STENOSIS IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. THE ARTERY DIAMETER WAS 6-7MM. THE DEGREE OF TORTUOSITY WAS MILD AND CALCIFICATION WAS MODERATE. THE IFU WAS FOLLOWED. A 7FR NON MEDTRONIC SHEATH WAS USED. THE VESSEL WAS NOT PRE-DILATED. IT WAS REPORTED DURING THE ATHERECTOMY THE SPIDER WIRE WAS PULLED BACK TO THE DISTAL END OF THE LESION. AN ATTEMPT WAS MADE TO RECAPTURE AND REDEPLOY THE SPIDER DISTALLY THOUGH THE ANGLED TEMPO QUA CATHETER (CORDIS). THE FILER WOULD NOT CAPTURE AND WAS PULLED FURTHER BACK WITHIN THE CALCIFIED LESION. NON PURPOSEFUL MOVEMENT FORWARD CAUSED WHAT APPEARED TO BE A PROLAPSE. SECOND ATTEMPT TO CAPTURE CAUSED DETACHMENT OF BASKET WITHIN LESION. THE DETACHMENT DID NOT RESULT IN INJURY TO THE PATIENT. THE GUIDEWIRE WAS ADVANCED THROUGH THE BASKET, 10 MM AMPLATZ SNARE DEPLOYED WITH SUCCESSFUL CAPTURE OF BASKET FOR REMOVAL. IMAGES TAKEN SHOWED NO VESSEL DAMAGE AS WELL AS IMPROVEMENT OF INITIAL LESION LIKELY DUE TO ATHERECTOMY. POST DILATION OF INITIAL LESION WITH 6X80 DCB RESULTED IN GOOD RESULT WITH AV FISTULA PRESENT WITHOUT EVIDENCE OF DISTAL STEAL OR LIMITATIONS O

  Patient problems: Insufficient Information

  MAUDE report 16387462 ↗
• InjuryJan 22, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A SPIDER FX WAS USED DURING THE TREATMENT OF A 10MM PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. THE DEGREE OF CALCIFICATION WAS MILD AND THERE WAS NO TORTUOSITY. THE ARTERY DIAMETER WAS 6MM. THE VESSEL WAS NOT PREDILATED. A 6 FR SHEATH WAS USED. THE IFU WAS FOLLOWED  DURING PREPARATION, PROCEDURE AND POST-PROCEDURE. IT WAS REPORTED AFTER THE DA WAS USED, THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE FILTER FROM THE PATIENTS BODY.  THE FILTER COULD NOT BE CAPTURED BY THE CATHETER. THE PHYSICIAN ATTEMPTED TO REMOVE THROUGH SHEATH BUT THE FILTER WOULD NOT FULLY CAPTURE INTO THE SHEATH. MANUAL ASPIRATION WAS ATTEMPTED TO REMOVE SOME DEBRIS IN FILTER, THEN REMOVAL WAS RE ATTEMPTED. FILTER BASKET THEN BROKE OFF. PHYSICIAN USED A SNARE TO GRAB BASKET AND ATTEMPTED TO REMOVE BASKET AND SHEATH FROM BODY. SHEATH CAME OUT BUT BASKET STUCK IN HOLE IN ARTERY. PATIENT WAS TAKEN TO OR FOR BASKET REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16221618 ↗
• InjuryAug 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A NON-MEDTRONIC ATHERECTOMY ALONG WITH A 7MM 0.014" SPIDER FX EMBOLIC PROTECTION AND GUIDEWIRE A NON-MEDTRONIC 6FR SHEATH DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL TIBIAL/POPLITEAL TRUNK WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THERE WAS NO DEVICE INTERACTION WITH THE SPIDER. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 4MM AND 20MM RESPECTIVELY. THE VESSEL WAS PRE AND POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT DURING WITHDRAWAL RESISTANCE WAS FELT, THE TIP DETACHED, FRAGMENTED AND EMBOLIZED IN THE VESSEL. A NON MEDTRONIC ATHERECTOMY DEVICE WAS BEING USED AND TIP OF THE SPIDER DEVICE BROKE OFF. SPIDER DETACHED, NOT ATHERECTOMY DEVICE. ATHERECTOMY DEVICE WAS REMOVED AND A MICRO GOOSE SNARE WAS USED TO RETRIEVE THE DETACHED PIECE.  PTA WAS PERFORMED AND PROCEDURE WAS COMPLETE. PATIENT TOLERATED PROCEDURE AND NO INJURIES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164736 ↗
• MalfunctionJun 2, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE 7MM SPIDER FX EMBOLIC PROTECTION DEVICE ALONG WITH A NON-MEDTRONIC 7FR 45CM SHEATH AND SPIDER WIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE RIGHT MID POPLITEAL ARTERY WITH 80% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 7MM AND 120MM RESPECTIVELY. THE VESSEL WAS NOT PRE DILATED BUT POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE WIRE SNAPPED AT THE TRANSITION POINT. PHYSICIAN TOOK OUT THE SPIDER AND PUT IN A NEW WIRE TO COMPLETE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11921660 ↗
• InjuryAug 21, 2020Device Damaged by Another Device; Device Damaged by Another Device

  PHYSICIAN INTENDED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A 100MM CALCIFIED LESION IN THE PATIENT¿ MID LEFT COMMON ILIAC ARTERY. VESSEL DIAMETER REPORTED AS 6MM. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 90% STENOSIS. A 7FR NON-MEDTRONIC (DESTINATION) SHEATH WAS USED. IFU WAS FOLLOWED AND THE DEVICES WERE PREPPED WITHOUT ISSUE. PRE-DILATION WAS NOT PERFORMED. ATHERECTOMY WAS PERFORMED TO DEBULK THE VESSEL. AN IMAGE WAS TAKEN, AND THE PHYSICIAN DECIDED TO CUT A LITTLE MORE. MORE PASSES WERE MADE WITH THE HAWKONE DEVICE PRIOR TO ATTEMPTED REMOVAL. ON REMOVAL ATTEMPT THE PHYSICIAN NOTED THE SPIDER FX WIRE HAD PROLAPSED ON THE HAWKONE DEVICE. SEVERAL ATTEMPTED WERE MADE TO ATTEMPT TO UNTANGLE THE WIRE UNSUCCESSFULLY. THE PHYSICIAN THEN PULLED THE DEVICE A LITTLE RESULTING IN A BREAK ABOVE THE CUTTER WINDOW. THE DISTAL END OF THE HAWKONE BROKE OFF WHERE THE CATHETER AND THE CUTTER CONNECTED. THE WHITE TIP WAS STILL ON THE FILTER WIRE. A SNARE WAS ADVANCED TO REMOVE THE DETACHED PORTION, BUT THIS WAS UNSUCCESSFUL. THE PROCEDURE WAS STOPPED AT THIS POINT, AND THE PATIENT WAS TRANSFERRED TO HOSPIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10435825 ↗
• InjuryJul 22, 2020Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  PHYSICIAN ATTEMPTED TO USE A SPIDER FX EMBOLIC PROTECTION DEVICE WITH A 7FR NON-MEDTRONIC SHEATH AND 0.035 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED AND PLAQUE LESION IN THE PATIENT¿S PROXIMAL, MID, AND DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS PERFORMED. IT IS REPORTED DURING THE CAPTURE PROCESS, THE SPIDER FX BECAME CAUGHT ON THE PROTÉGÉ EVERFLEX DEVICE. A 0.035 NON-MEDTRONIC WIRE WAS USED TO CAPTURE THE SPIDER FX AND SEVERAL ATTEMPTS WERE MADE TO SNARE IT USING A NON-MEDTRONIC SNARE DEVICE FROM BOTH PEDAL AND FEMORAL ACCESS. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306991 ↗
• MalfunctionJun 8, 2020Peeled/Delaminated; Peeled/Delaminated

  PHYSICIAN WAS ATTEMPTING TO USE A 5.0MM AND 7.0MM SPIDER FX ALONG WITH A NON-MEDTRONIC 7FR SHEATH DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT MID SFA TO POPLITEAL. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 10MM RESPECTIVELY. THE VESSEL WAS SEVERELY TORTUOUS. THE IFU WAS FOLLOWED. IT WAS REPORTED THAT THE PTFE COATING ON THE SPIDER WIRE CAME OFF ON BOTH DEVICES. ONE THE 5.0MM SPIDER, THE PTFE COATING WAS SEEN ON THE WET GAUZE AS WIRE WAS WIPED DOWN PRIOR TO INSERTION FOR SUPPORT CATHETER. THE DEVICE WAS INTRODUCED INTO THE PATIENT'S VASCULATURE. ON THE 7.0MM SPIDER, THE PTFE COATING WAS NOTED TO BE COMING OFF DURING USE. NO DIFFICULTIES WERE REPORTED DURING INSERTION OR REMOVAL OF THE 7.0 SPIDER. A PTA WAS PERFORMED OVER THE 7.0MM SPIDER, THEN FILTER WAS REMOVED USING RETRIEVAL DEVICE. IT IS BELIEVED THAT THE UNDERLYING WIRE WERE NOT EXPOSED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10127209 ↗
• InjuryJan 14, 2020Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material

  PHYSICIAN USED A SPIDER FX EMBOLIC PROTECTION DEVICE ALONG WITH A NON MEDTRONIC 6FR SHEATH WAS USED DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL SFA, POPLITEAL, TIBIAL/POPLITEAL TRUNK AND ANTERIOR TIBIAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 80MM RESPECTIVELY. THE VESSEL IS MODERATELY TORTUOUS. ABNORMALITIES REPORTED IN RELATION TO ANATOMY WAS AORTO ILIAC STEEP CALCIFIED BIFURCATION. THE VESSEL WAS NOT PRE DILATED BUT POST DILATED. THE IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. IT WAS REPORTED THAT THE FILTER TIP WAS DETACHED/DAMAGED, POSSIBLY UNCOILING OF DISTAL NITINOL TIP ON SPIDER WIRE. FIBER STRANDS WERE NOTED AT SHEATH HUB AFTER REMOVAL OF SPIDER FILTER WHICH WAS DONE VIAL PARTIAL CAPTURE WITH THE SPIDERV RETRIEVAL DEVICE. ATHERECTOMY, ANGIOPLASTY AND STENT WERE USED TO COMPLETE THE PROCEDURE. THE TIP/FILTER DETACHMENT DID NOT RESULT IN PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587038 ↗
• InjuryDec 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A SPIDER FX EMBOLIC PROTECTION DURING PTCA PROCEDURE. IT WAS REPORTED THAT THE SPIDER FILTER WIRE WAS INTRODUCED INTO THE RIGHT ARTERY, COULD NOT GET THE WIRE AND FILTER TO LAND WHERE PHYSICIAN WANTED. THE WIRE AND FILTER WAS PULLED BACK AND OUT OF THE LEG. IT WAS NOTICED THAT THE USED WIRE WAS NOT INTACT COMPARED TO THE NEW WIRE PLACED ON THE TABLE. THE TIP WAS MISSING. PHYSICIAN WAS ABLE TO SNARE THE TIP FROM THE DISTAL LEG ARTERY. A NEW SPIDER FX AND PTA WERE USED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT INJURY WAS REPORTED FOR THIS EVENT.

  Patient problems: Injury

  MAUDE report 9444688 ↗
• InjuryMay 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  SPIDER FX DEVICE WAS USED DURING A CARDIAC CATHETERIZATION PROCEDURE. THE SPIDER FX WAS ADVANCED INTO GRAPH TO CATCH A CLOT FROM ADVANCING INTO THE NATIVE ARTERY. WHEN ADVANCING THE WIRE THROUGH A STENT, THE TIP OF THE WIRE BECAME ENTANGLED BEHIND THE STENT STRUTS, THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE BUT IN DOING SO BROKE THE WIRE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND DEPLOYED ANOTHER STENT TO ENTRAP THE FRACTURED WIRE TO PREVENT FURTHER PROBLEMS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8635456 ↗
• MalfunctionMay 2, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A HAWKONE H1-M ATHERECTOMY DEVICE ALONG WITH SPIDER 7.0 FILTER TO TREAT A 90% STENOTIC SEVERLY CALCIFIED LESION OF MODERATE TORTUOSITY IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). THE IFU WAS FOLLOWED IN PREPARATION, DURING THE PROCEDURE AND POST PROCEDURE. THE GUIDEWIRE WAS HYDRATED AT PREP; DEVICE WAS ADVANCED OVER A BIFURCATION WITH NO RESISTANCE EXPERIENCED. THE CATHETER ADVANCED EASILY AND MADE 3 PASSES WITH NO ISSUE. AS THE PHYSICIAN ATTEMPTED TO PULL THE CATHETER OUT OF THE VESSEL HE ENCOUNTERED RESISTANCE. HE WAS INSTRUCTED TO ADVANCE THE CATHETER AND ROTATE THE CATHETER IN THE OPPOSITE DIRECTION FROM THE PROCEDURE. RESISTANCE WAS STILL PRESENT. AFTER LOOKING AT THE SHEATH A SMALL LOOP WAS NOTICED AT THE TIP. THE PHYSICIAN MANIPULATED THE CATHETER AND WIRE TO SEEMINGLY REMOVE THE LOOP. ON THE ENSUING ATTEMPT TO REMOVE THE CATHETER WAS NOTED TO HAVE MORE RESISTANCE. WHEN TRYING TO ADVANCE THE WIRE AND CATHETER KINKED TEMPORARILY. AT THIS POINT THE CATHETER AND WIRE WERE SEIZED TOGETHER AND REMOVED IN TANDEM THROUGH THE SHEATH. ONCE OUT OF THE BODY, THE KINKED WIRE AND TWISTED CATHETER WERE OBSERVED. WH EN EXAMINED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8572521 ↗
• MalfunctionApr 29, 2019Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  THE PHYSICIAN WAS USING A SPIDERFX WITH A 7FR 45CM TERUMO SHEATH TO TREAT A 100CM MODERATELY CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER WAS 6MM. RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL OF THE DEVICE INTO THE SHEATH. IT WAS REPORTED THAT DURING REMOVAL OF THE DEVICE FROM THE PATIENT A KINK WAS OBSERVED PROXIMAL TO THE BASKET AND THE FILTER WAS DETACHED FROM THE WIRE. ALL DEVICES WERE REMOVED FROM THE PATIENT AND THE SHEATH WAS EXCHANGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8560022 ↗
• MalfunctionApr 3, 2019Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE A HAWKONE M DEVICE WITH A 7MM SPIDER FX EMBOLIC PROTECTION DEVICE AND A 6FR (BIOTRONICK) 45CM SHEATH DURING TREATMENT OF A 90% STENOSED, 50MM PLAQUE LESION IN THE PATIENT¿S MID RIGHT COMMON FEMORAL ARTERY OF DIAMETER 7MM. IFU WAS FOLLOWED AND THE DEVICES WERE PREPPED WITHOUT ISSUE. WIRE WAS HYDRATED AT PREPARATION. PRE-DILATION WAS PERFORMED. IT IS REPORTED THAT DURING WITHDRAWAL SEVERE RESISTANCE WAS FELT DUE TO WIRE PROLAPSE. THIS RESULTED IN DAMAGE TO THE MID NOSECONE CAUSING IT TO BREAK IN HALF. THE DEVICE WAS THEN UNABLE TO BE WITHDRAWN THROUGH THE SHEATH. THE REST OF THE NOSECONE AND SPIDER WERE THEN PULLED AS ONE UNIT THROUGH THE SHEATH TO REMOVE FROM THE PATIENT. NO DAMAGE TO VESSEL AND NO FOREIGN BODIES LEFT BEHIND. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY, IT WAS NOTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8477150 ↗
• InjuryMar 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING A HAWKONE M TO TREAT A SEVERELY CALCIFIED 120MM CTO IN THE PROXIMAL COMMON ILIAC ARTERY, SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. LITTLE TORTUOSITY WAS REPORTED IN THE 6MM DIAMETER VESSEL. A 7MM 0.14 SPIDERFX EMBOLIC PROTECTION, TRAILBLAZER AND A 6FR COOK SHEATH WERE ALSO USED IN THE PROCEDURE. THE IFU WAS FOLLOWED AND THE VESSEL WAS PREDILATED. IT WAS REPORTED THAT AFTER COMPLETING THE ATHERECTOMY WITH THE HAWKONE, THE SPIDERFX COULD NOT BE RETRIEVED INTO THE RECOVERY CATHETER. IT COULD NOT BE RETRIEVED INTO THE TRAILBLAZER 6FR GUIDE CATHETER OR THE SHEATH. WHEN ATTEMPTING TO EXCHANGE THE SHEATH TO A 7R THE BASKET ON THE SPIDERFX SNAPPED OFF AND THE PATIENT WAS TAKEN TO SURGERY FOR A CUTDOWN TO REMOVE THE DETACHED WIRE.

  Patient problems: Patient Problem/Medical Problem; Unspecified Tissue Injury

  MAUDE report 8451212 ↗
• MalfunctionFeb 19, 2019Compatibility Problem; Compatibility Problem

  THE PHYSICIAN INTENDED TO USE THE HAWKONE WITH A SPIDER FX 7MM AND A TERUMO SHEATH AND A 0.35 GUIDEWIRE, TO TREAT A HEAVILY CALCIFIED LESION WITH 70% STENOSIS IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES NOTED. ARTERY DIAMETER 6MM, LESION LENGTH 200MM. IT WAS REPORTED DURING THE PROCEDURE THE GUIDEWIRE WAS WRAPPED AROUND THE HAWKONE AND RESISTANCE WAS ENCOUNTERED REMOVING THE DEVICE FROM THE PATIENT BUT WAS ULTIMATELY REMOVED THROUGH THE SHEATH. IT WAS REPORTED THAT THE CUTTER WAS IN THE HOUSING DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH DCB. NO INJURY TO THE PATIENT REPORTED. WHEN THE SPIDER DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION, IT WAS NOTED THAT THE DEVICE WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8350404 ↗
• InjuryDec 3, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING TREATMENT OF MODERATELY CALCIFIED FIBROUS LESIONS WITH 80% STENOSIS IN THE DISTAL MID LEFT SUPERFICIAL FEMORAL ARTERY (ARTERY DIAMETER 6MM), PHYSICIAN FIRST PREPPED TWO LESIONS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE AND THEN POST DILATED WITH TWO IN.PACT ADMIRAL BALLOONS. FOLLOWING POST-DILATION, A DISSECTION WAS NOTED IN THE DISTAL SFA AND POPLITEAL ARTERY THAT WAS DETERMINED TO REQUIRE STENTING. THE PHYSICIAN THEN USED AN EVERFLEX ENTRUST WITH A NON-MEDTRONIC 7FR. 55CM SHEATH AND A SPIDER FX 7MM EMBOLIC PROTECTION DEVICE. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING DEPLOYMENT. THE LENGTH OF THE DEPLOYED STENT WAS 6X120MM AND WAS ELONGATED TO 210MM. ONCE THE STENT WAS PROPERLY POSITIONED FOR DEPLOYMENT THE RED TAB WAS FULLY PULLED AND THE DEPLOYMENT WHEEL WAS THEN TURNED TO DEPLOY. THE PHYSICIAN THEN FELT RESISTANCE IN THE WHEEL AFTER ONLY A FEW TURNS AND WAS UNABLE TO DEPLOY THE STENT FURTHER. THE WHEEL HAD JAMMED. THE PHYSICIAN DISASSEMBLED THE DELIVERY SYSTEM TO FIND THE DELIVERY WHEEL HAD BECOME ENTANGLED WITH THE IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124177 ↗
• InjuryOct 2, 2018Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE THE SPIDER FX AS PER IFU TO TREAT A SEVERELY CALCIFIED LESION IN THE POPLITEAL ARTERY. THE PERCENTAGE STENOSIS WAS REPORTED TO BE BETWEEN 80-90%. THE VESSEL WAS NON-TORTUOUS. IT WAS REPORTED THE PHYSICIAN ENCOUNTERED DIFFICULTIES ADVANCING THE SPIDER. THE SPIDER WAS REMOVED FROM THE PATIENT USING A NON-MEDTRONIC CATHETER TO TRAP IT. BOTH THE SPIDER FX AND NON-MEDTRONIC CATHETER WERE REMOVED IN TANDEM. ON REMOVAL, THERE WAS TIP DAMAGE OBSERVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925196 ↗