Esprit™ 1203350-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 08717648357091), received between Aug 13, 2024 and Sep 22, 2026 — classified as 1 death, 10 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861221 ↗
• InjurySep 14, 2026Difficult to Remove; Difficult to Advance; Material Deformation; Material Twisted/Bent

  It was reported that the procedure was to treat a lesion in an unspecified artery. The 3.5x38mm Esprit BTK would not advance onto the 0.014" Command ES guidewire. The device did not enter sheath and would not go further. Scaffold and balloon were noted to be bunched up and deformed. Then the Esprit could not be removed from the guidewire either. The guidewire was cut just before the balloon tip to proceed. The same guidewire with another Esprit was used with no issue to complete the procedure. There was no adverse patient effect and there was no clinically significant delay in the procedure. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758254 ↗
• MalfunctionSep 10, 2026Nonstandard Device; Deformation Due to Compressive Stress; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721559 ↗
• MalfunctionJul 30, 2026Material Separation; Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090196 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025, ONE 3.50X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE LEFT ANTERIOR TIBIAL ARTERY. DUPLEX ULTRASOUND FROM (B)(6) 2025 SHOWED SEVERE STENOSIS IN THE ANTERIOR TIBIAL ARTERY. ON (B)(6) 2025 THE PATIENT WAS SEEN FOR HIS 180-DAY FOLLOW-UP VISIT AND WAS NOTED TO HAVE DECREASED LOWER LIMB PULSES. ANGIOGRAM SHOWED THAT THERE WAS 90% STENOSIS PROXIMAL TO THE STUDY DEVICE IN THE ANTERIOR TIBIAL ARTERY. LASER ATHERECTOMY AND ANGIOPLASTY WERE PERFORMED IN THE LEFT ANTERIOR TIBIAL ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 23873053 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD AN ESPRIT BELOW THE KNEE IMPLANTED IN THE RIGHT TPT TRUNK. TWO DAYS LATER THE PATIENT BEGINS TO EXPERIENCE PURPURA (RASH, ALLERGIC REACTION). A STEROID SHOT WAS ADMINISTERED; HOWEVER, THE PATIENT IS STILL EXPERIENCING PURPURA LEG, ARMS AND TRUNK. THE PATIENT NEVER LISTED ANY ALLERGIES OR STATED ANY ALLERGY TESTING HAS BEEN DONE. THE PATIENT IS BEING SEEN BY THE PHYSICIAN FOR RE-EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23846312 ↗
• MalfunctionDec 18, 2025Stretched; Device Damaged by Another Device; Stretched; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. A NON-ABBOTT BALLOON WAS USED FOR PRE-DILATATION UP AND DOWN THE LESION BUT A PART OF IT DID NOT OPEN. THE JADE BALLOON WAS USED TO OPEN THE LESION SOME MORE AND AN ORBITAL ATHERECTOMY SYSTEM (OAS) WAS ALSO USED. THREE ESPRIT BTK STENTS WERE IMPLANTED TO THE DISTAL PORTION OF THE RIGHT ANTERIOR TIBIAL ARTERY WITHOUT ISSUES. THE 3.5X38MM ESPRIT BTK STENT WAS THEN IMPLANTED TO THE PROXIMAL PORTION SUCCESSFULLY. HOWEVER, GUIDEWIRE ACCESS WAS LOST. A NEW NON-ABBOTT GUIDEWIRE WAS ATTEMPTED TO GAIN ACCESS BUT FAILED EVEN WITH THE AID OF A .018 SUPPORT CATHETER. DURING THIS TIME, THE IMPLANTED SCAFFOLD WAS NOTED TO HAVE STRETCHED STILL WITHIN THE TARGET LESION UPON FLUOROSCOPY, AND THE MARKERS WERE INTACT. IT WAS NOTED THAT EITHER UNSPECIFIED GUIDEWIRE OR THE MICRO CATHETER DAMAGED THE SCAFFOLD. NO INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS ABORTED SINCE GUIDEWIRE ACCESS COULD NOT BE RE-ESTABLISHED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843500 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT UNDERWENT THE STUDY PROCEDURE WITH IMPLANT OF THE 2.5X38 MM ESPRIT BTK SCAFFOLD IN THE RIGHT PERONEAL ARTERY. THERE WAS NO RESIDUAL STENOSIS POST INDEX PROCEDURE. FOUR DAYS LATER, ON (B)(6) 2025 THE PATIENT WAS SEEN FOR HER ROUTINE DUPLEX ULTRASOUND WHICH FOUND 75-99% STENOSIS IN THE INDEX, MID ANTERIOR TIBIAL ARTERY, ALONG WITH SEGMENT OCCLUSION IN THE PROXIMAL, MID, AND DISTAL PERONEAL ARTERY. THE PATIENT DID NOT HAVE SYMPTOMS AND DID NOT HAVE NEW OR WORSENING WOUNDS; THEREFORE, NO INTERVENTION WAS INDICATED FOR THE OCCLUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23829917 ↗
• MalfunctionDec 16, 2025Migration; Migration

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT POSTERIOR TIBIAL ARTERY. A NON-ABBOTT FILTRATION DEVICE WAS PLACED IN THE VESSEL AND ATHERECTOMY PERFORMED. THE 3.50X35MM ESPRIT BTK SYSTEM WAS ADVANCED AND THE SCAFFOLD DEPLOYED IN THE TARGET LESION WITH THE SCAFFOLD WELL APPOSED TO THE VESSEL WALL. DURING ADVANCEMENT OF THE FILTRATION DEVICE RETRIEVAL CATHETER, IT BECAME CAUGHT ON THE IMPLANTED SCAFFOLD STRUTS. THE SCAFFOLD WAS PUSHED FURTHER DOWN THE ARTERY BUT WAS IN THE INTENDED LESION STILL AND DID NOT STRETCH. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817395 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, ONE 3.5X38 MM ESPRIT BTK WAS IMPLANTED IN THE HEAVILY CALCIFIED, RIGHT PROXIMAL POSTERIOR TIBIAL ARTERY. ON (B)(6) 2025 THE PATIENT WAS NOTED TO HAVE A NEW WOUND AND A NEW OCCLUSION IN THE POSTERIOR TIBIAL ARTERY. REVASCULARIZATION OF THE TARGET LIMB WAS PERFORMED ON (B)(6) 2025 WITH 0% RESIDUAL OCCLUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 23791428 ↗
• DeathDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A RECTAL BLEED ON (B)(6) 2025. COLONOSCOPY REVEALED A PERIRECTAL HEMATOMA WHICH WAS CONTROLLED. IN THE OPINION OF THE PHYSICIAN, THE ESPRIT BTK SCAFFOLD IS NOT RELATED TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Vascular Problem

  MAUDE report 23771553 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT IN THE OPINION OF THE PHYSICIAN, THE PSEUDOANEURYSM ARISING FROM THE SUPERFICIAL FEMORAL ARTERY, AND RELATED ISSUES, WAS NOT CAUSED BY AN ABBOTT DEVICE. THE PHYSICIAN USED A SUTURE TO CLOSE THE LEFT GROIN PROCEDURAL ACCESS SITE ON 9/23/2025. ALTHOUGH THE PSEUDOANEURYSM, HEMORRHAGE, ADMINISTRATION OF MEDICATION AND BLOOD TRANSFUSION ARE NOT RELATED TO THE IMPLANTED SCAFFOLD, THIS EVENT HAS BEEN REPORTED; THEREFORE, IT WILL REMAIN REPORTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Pseudoaneurysm

  MAUDE report 23750764 ↗
• MalfunctionNov 19, 2025Peeled/Delaminated; Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn; Peeled/Delaminated; Deformation Due to Compressive Stress; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A POSTERIOR TIBIAL ARTERY. AN UNSPECIFIED ESPRIT BTK SCAFFOLD OVER A 0.014" GUIDE WIRE WAS DEPLOYED. A 3.50X38MM ESPRIT BTK RESORBABLE SCAFFOLD SYSTEM, WAS ADVANCED WHEN IT WAS OBSERVED THAT THE UNSPECIFIED 0.014" GUIDEWIRE WAS NO LONGER AT THE POSTERIOR TIBIAL ARTERY. THE GUIDE WIRE WAS ADJUSTED AND THE ESPRIT BTK PULLED BACK. AN ATTEMPT WAS MADE TO ADVANCE THE ESPRIT BTK; HOWEVER, UNSUCCESSFUL. THE ESPRIT BTK WAS REMOVED AND THE SHAFT WAS OBSERVED TO BE KINKED. THE FAILURE TO ADVANCE WAS NOTED TO BE DUE TO THE KINK IN THE DELIVERY SYSTEM OF THE ESPRIT BTK. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS OBSERVED SHREDDING NOTED AT THE DISTAL BALLOON FOLDS AND THE GUIDE WIRE EXIT NOTCH WAS TORN DISTALLY FOR A LENGTH OF 5 MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598242 ↗
• MalfunctionSep 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREP, STAFF NOTICED THE 2.5X38 ESPRIT BTK SCAFFOLD DID NOT LOOK FULLY CRIMPED ON THE BALLOON; IT LOOKED LOOSE. NO PATIENT WAS INVOLVED. ANOTHER ESPRIT BTK WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074303 ↗
• MalfunctionAug 14, 2025Break; Failure to Advance; Deformation Due to Compressive Stress; Break; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. FOLLOWING ATHERECTOMY AND THE DEPLOYMENT OF UNSPECIFIED STENTS, A 3.5X38MM ESPRIT BTK WAS ATTEMPTED TO BE ADVANCED; HOWEVER, THE DEVICE ONLY MADE IT HALFWAY THROUGH THE LESION AND FAILED TO CROSS AND THE SHAFT KINKED. IT IS UNKNOWN WHY THE DEVICE FAILED TO CROSS BECAUSE AN UNSPECIFIED BALLOON CATHETER HAD ALREADY CROSSED SUCCESSFULLY PRIOR TO THE ATTEMPT TO CROSS THE ESPRIT BTK. A SECOND 3.5X38MM ESPRIT BTK WAS THEN ADVANCED, THROUGH RESISTANCE, AND SUCCESSFULLY DEPLOYED AND POST-DILATED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS REVEALED THAT THE SUPPORT SKIVE/WIRE/BAYONET SEPARATED BUT HELD TOGETHER BY THE OUTER MEMBER. THE ACCOUNT CONFIRMED THE CORRECT DEVICE WAS RETURNED, AND NOTED THAT THEY WERE UNAWARE OF THE DAMAGES FOUND IN THE PRODUCT RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809835 ↗
• InjuryAug 12, 2025Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR TIBIAL ARTERY. THE 3.50X38MM ESPRIT BTK SYSTEM WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION AND THE SHAFT COILED BACK ON ITSELF AND COULD NOT BE REMOVED. A SNARE DEVICE WAS USED TO RETRIEVE THE SYSTEM. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781455 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.5X18 MM, 3.5X38 MM, 3.75X18 MM AND A 3.75X38 MM ESPRIT BELOW THE KNEE (BTK) BIORESORBABLE VASCULAR SCAFFOLD WERE IMPLANTED ON (B)(6) 2025 IN THE RIGHT ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION AND 100% STENOSIS. THE STENTS APPEARED OCCLUDED UNDER X RAY FROM (B)(6) 2025. TREATMENT WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22730577 ↗
• MalfunctionJul 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED ARTERY. THE 3.5X38MM ESPRIT BTK DEVICE WAS BEING ADVANCED TO THE TARGET LESION; HOWEVER, THE SCAFFOLD SEPARATED FROM THE WIRE [DISLODGED]. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22559466 ↗
• MalfunctionJul 15, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT TWO ESPRIT BTK SCAFFOLDS (3.0X38, 3.5X38 MM) HAD A FAILURE TO DEPLOY. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509544 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, ONE 3.5X38 MM ESPRIT SCAFFOLD WAS IMPLANTED IN THE RIGHT ANTERIOR TIBIAL ARTERY (ATA). THAT SAME DAY, THREE 6.0 MM STENTS WERE ALSO IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT WAS DISCHARGED HOME THE SAME DAY, (B)(6) 2024. ON (B)(6) 2025 THE PATIENT HAD WORSENING CLAUDICATION SYMPTOMS IN BOTH LEGS; HOWEVER, THE PAIN ON THE RIGHT LEG WAS GREATER. THERE WAS NO PAIN AT REST AND THERE WAS NO TISSUE LOSS. AN OUTPATIENT DIAGNOSTIC ANGIOGRAM SHOWED DIMINISHED PERFUSION TO THE RIGHT LEG. THE SFA, POPLITEAL ARTERY, TIBIOPERONEALTRUNK, AND PERONEAL ARTERY WERE 100% STENOSED. THE ATA WAS 100% STENOSED AT THE ORIGIN WITH RECONSTITUTION THROUGH THE PROFUNDA TO GENICULATE COLLATERALS AND PATENT THROUGH THE CALF DOWN TO THE LEVEL OF THE ANKLE WHERE THERE WAS NARROWING AND THEN BEYOND TO THE FOOT. ONLY A SMALL PORTION OF THE ATA HAD STENOSIS. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL. THE PATIENT WAS GIVEN FENTANYL AND VERSED AS PART OF THE PROCEDURAL PAIN MANAGEMENT. THE PATIENT HAD AN OFFICE VISIT WITH THE PHYSICIAN ON (B)(6) 2025. THE PHYSICIAN DOES NOT RECOMMEND INTERVENTION AT THIS TIME. NO ADDITIONAL INFORMATION W

  Patient problems: Ischemia; Pain; Stenosis

  MAUDE report 22384371 ↗
• MalfunctionMay 14, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. PRE-DILATATION WAS PERFORMED AND THE 3.5X38 MM ESPRIT BELOW THE KNEE BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS ADVANCED. REPORTEDLY, THERE WAS RESISTANCE DIFFICULTY ADVANCING THE ESPRIT OVER THE 0.014 VIPEWIRE GUIDEWIRE. THE DEVICE BECAME STUCK ON THE WIRE REQUIRING THE REMOVAL OF THE GUIDEWIRE AND THE DEVICE AS A SINGLE UNIT. A NEW ESPRIT BTK 3.50 X 38 AND A NON-ABBOTT GUIDE WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020812 ↗
• MalfunctionApr 17, 2025Break; Difficult to Flush; Improper or Incorrect Procedure or Method; Break; Difficult to Flush; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE TECH COULD NOT FLUSH THE 3.5X38 MM ESPRIT BTK DELIVERY SYSTEM DURING PREP. NO PATIENT WAS INVOLVED. THE TECH DID NOT SEE HEPARINIZED SALINE COMING OUT OF THE MONORAIL PORT DURING PREP. THE TECH REMOVED THE STYLET FROM THE DELIVERY SYSTEM AND ATTACHED THE SYRINGE TO THE YELLOW COVER (SHEATH COVERS SCAFFOLD). THE TECH TRIED TO FLUSH, BUT THE FLUID WAS NOT SEEN EXITING. WHEN THAT DID NOT WORK, THEN THEY REMOVED THE SHEATH AND TRIED TO FLUSH, BUT IT STILL DID NOT FLUSH. THEY USED ANOTHER ESPRIT BTK TO COMPLETE THE PROCEDURE AND THAT ONE FLUSHED PROPERLY. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A BREAK ON THE SUPPORT/SKIVE/WIRE/BAYONET 5.6 CM DISTAL TO THE OUTER MEMBER TO HYPOTUBE SEAL BUT REMAINED IN THE INFLATION LUMEN OF THE OUTER MEMBER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861302 ↗
• MalfunctionApr 4, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. THE 3.50X38MM RX ESPRIT BTK SYSTEM WAS ADVANCED OVER A 0.014 COMMAND GUIDE WIRE HOWEVER RESISTANCE WAS MET OUTSIDE THE PATIENT. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A MAILMAN 0.014 WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE INNER MEMBER WAS SEPARATED WITHIN THE OUTER MEMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21772852 ↗
• MalfunctionJan 13, 2025Break; Failure to Advance; Material Twisted/Bent; Break; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO). PRE-DILATATION WAS PERFORMED WITH A 2.5 MM BALLOON AND 2 PREVIOUS 3.0 MM SCAFFOLDS HAD BEEN IMPLANTED IN THE TARGET LESION WITHOUT ISSUE. THE THIRD, 3.5X38 MM ESPRIT BTK SCAFFOLD FAILED TO CROSS THE LESION DUE TO THE ANATOMY AND UPON REMOVAL THE HYPOTUBE SEEMED TWISTED/COILED. THE DEVICE WAS NOT USED ANY FURTHER AND THE LESION WAS FURTHER PRE-DILATED WITH A HALF SIZE BIGGER BALLOON AND ANOTHER ESPRIT BTK SCAFFOLD DELIVERY SYSTEM EASILY ADVANCED AND WAS IMPLANTED IN THE INTENDED LOCATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE SUPPORT SKIVE/WIRE/BAYONET WAS SEPARATED 7.5CM DISTAL TO THE OUTER MEMBER TO HYPOTUBE SEAL BUT WAS HELD TOGETHER BY THE OUTER MEMBER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21141582 ↗
• MalfunctionDec 20, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY. THE 3.50X38MM ESPRIT BTK SYSTEM WAS ADVANCED TO THE TARGET LESION AND THE BALLOON INFLATE TO 9 ATMOSPHERES, HOWEVER THE SCAFFOLD DID NOT DEPLOY. THE BTK SYSTEM WAS REMOVED AND THE SCAFFOLD WAS CONFIRMED TO STILL BE ON THE BALLOON. ANOTHER SAME SIZE ESPRIT WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE SCAFFOLD WAS DEPLOYED WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20987071 ↗