MANTA IPN928166Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00856279007307), received between Jun 25, 2024 and Apr 28, 2025 — classified as 1 death, 28 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (12 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  PROTAMINE WAS GIVEN. NO COMPLICATIONS REPORTED DURING/AFTER MANTA DEPLOYMENT. SITE CONFIRMS DEPLOYMENT PER IFU. MANTA DELIVERY SYSTEM DID NOT BECOME KINKED AT ANY POINT DURING THE CASE. THERE WAS NO SIGN OF BACTERIAL CONTAMINATION OR ANTEGRADE PUNCTURE DURING THE INDEX PROCEDURE. TIME TO HEMOSTASIS WAS 1 SECOND. NO ADJUNCTIVE METHOD WAS REQUIRED TO ACHIEVE ARTERIAL HEMOSTASIS AT THE MANTA CLOSURE SITE. POST DEPLOYMENT FEMORAL ANGIOGRAM WAS COMPLETED AND SHOWED PATENT TARGET ARTERY AT THE MANTA DEPLOYMENT SITE. VISUAL CHECK OF THE TARGET FEMORAL ACCESS SITE WAS PERFORMED. THE DEVICE DEFICIENCY OCCURRED DURING A PROCEDURE FOR A SINGLE PATIENT IN WHICH THREE MANTA DEVICES DID NOT DEPLOY. ACCORDING TO THE RESEARCH COORDINATOR, THE MANTA SHEATH WAS PREVENTING PROPER INSERTION OF THE DEVICE, WHICH PROMPTED THE CLINICAL TEAM TO CHANGE OUT THE SHEATHS DURING THE PROCEDURE. THE TIME OF DEPLOYMENT RECORDED ON THE CRF CORRESPONDS TO THE FINAL SUCCESSFUL ATTEMPT. ADDITIONAL INFORMATION: " THE BYPASS TUBE WOULD NOT ADVANCE FAR ENOUGH INTO THE SHEATH FOR THE DEVICE TO BE ADVANCED. WE REMOVED THE DEVICE AND READVANCED A NEW MANTA. THE INITIAL SHEATH WAS NOT REMOVED. THE FIRST MANTA WOULDN'T ADVAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917147 ↗
• MalfunctionApr 28, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  DATE OF TAVR: (B)(6) 2025. ULTRASOUND AND MICRO PUNCTURE WERE USED TO GAIN ACCESS; THERE WAS NO DIFFICULTY GAINING ACCESS PER DATA ENTRY. ONLY ONE FEMORAL ARTERIAL PUNCTURE WAS USED IN THE SAME VESSEL DURING INITIAL ACCESS FOR THE INTERVENTIONAL PROCEDURE. TARGET ARTERY FOR MANTA CLOSURE: LEFT CFA (9 MM). TISSUE DEPTH RECORDED: 5 CM. DEPLOYMENT IS AT 6 CM. NUMBER OF SHEATH EXCHANGES MADE PRIOR TO MANTA SHEATH INSERTION WAS 2. PROCEDURE SHEATH USED WAS AN ESHEATH SIZE 14F. TAVR VALVE WAS SIZE 26. SITE REPORTED NO INTRAPROCEDURAL COMPLICATION AT THE FEMORAL ACCESS SITE BEFORE PROCEDURE SHEATH REMOVAL. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. ACT WAS 275 SEC AND SYSTOLIC BP WAS 122 MMHG PRIOR TO CLOSURE. 100MG OF PROTAMINE WAS GIVEN. NO COMPLICATIONS REPORTED DURING/AFTER MANTA DEPLOYMENT. SITE CONFIRMS DEPLOYMENT PER IFU. MANTA DELIVERY SYSTEM DID NOT BECOME KINKED AT ANY POINT DURING THE CASE. THERE WAS NO SIGN OF BACTERIAL CONTAMINATION OR ANTEGRADE PUNCTURE DURING THE INDEX PROCEDURE. TIME TO HEMOSTASIS WAS 1 SECOND. NO ADJUNCTIVE METHOD WAS REQUIRED TO ACHIEVE ARTERIAL HEMOSTASIS AT THE MANTA CLOSURE SITE. POST DEPLOYMENT FEMORAL ANGIOGRAM WAS COMPLETED AND SHOWED PATENT TA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21917145 ↗
• MalfunctionApr 28, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  DATE OF TAVR: (B)(6) 2025. ULTRASOUND AND MICRO PUNCTURE WERE USED TO GAIN ACCESS; THERE WAS NO DIFFICULTY GAINING ACCESS PER DATA ENTRY. ONLY ONE FEMORAL ARTERIAL PUNCTURE WAS USED IN THE SAME VESSEL DURING INITIAL ACCESS FOR THE INTERVENTIONAL PROCEDURE. TARGET ARTERY FOR MANTA CLOSURE: LEFT CFA (9 MM). TISSUE DEPTH RECORDED: 5 CM. DEPLOYMENT IS AT 6 CM. NUMBER OF SHEATH EXCHANGES MADE PRIOR TO MANTA SHEATH INSERTION WAS 2. PROCEDURE SHEATH USED WAS AN ESHEATH SIZE 14F. TAVR VALVE WAS SIZE 26. SITE REPORTED NO INTRAPROCEDURAL COMPLICATION AT THE FEMORAL ACCESS SITE BEFORE PROCEDURE SHEATH REMOVAL. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. ACT WAS 275 SEC AND SYSTOLIC BP WAS 122 MMHG PRIOR TO CLOSURE. 100MG OF PROTAMINE WAS GIVEN. NO COMPLICATIONS REPORTED DURING/AFTER MANTA DEPLOYMENT. SITE CONFIRMS DEPLOYMENT PER IFU. MANTA DELIVERY SYSTEM DID NOT BECOME KINKED AT ANY POINT DURING THE CASE. THERE WAS NO SIGN OF BACTERIAL CONTAMINATION OR ANTEGRADE PUNCTURE DURING THE INDEX PROCEDURE. TIME TO HEMOSTASIS WAS 1 SECOND. NO ADJUNCTIVE METHOD WAS REQUIRED TO ACHIEVE ARTERIAL HEMOSTASIS AT THE MANTA CLOSURE SITE. POST DEPLOYMENT FEMORAL ANGIOGRAM WAS COMPLETED AND SHOWED PATENT TA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916686 ↗
• InjuryApr 22, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "INCOMPLETE HEMOSTASIS AND VESSEL EXTRAVASATION UNDER FLUOROSCOPY." ADDITIONAL INFORMATION: "DURING A TAVR PROCEDURE, MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN CENTRAL ACCESS IN THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 7MM WITH NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 3+1=4. SYSTOLIC BLOOD PRESSURE WAS 153 AND ACT WAS 243. 12K HEPARIN AND 100MG OF PROTAMINE WERE ADMINISTERED INTRAVENOUSLY DURING THE PROCEDURE. PERIPHERAL ANGIOPLASTY BALLOON AND STENT WAS APPLIED TO TREAT EXTRAVASATION AND INCOMPLETE HOMEOSTASIS. TIME TO HEMOSTASIS WAS 10-15 MINUTES AND PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21879775 ↗
• InjuryApr 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT "MANTA ANCHOR CAUGHT ON CALCIUM, NOT ALLOWING FULL OPPOSITION TO VESSEL. MANTA PGLA ANCHOR DIMINISHED FLOW TO SFA AND PROFUNDA. BALLOON ANGIOPLASTY ATTEMPTED WITH NO SUCCESS. CUTDOWN PERFORMED ON LEFT FA. MANTA DEVICE FULLY RECOVERED AND FLOW RESTORED." ADDITIONAL INFORMATION: "DURING A TAVR PROCEDURE, MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN CENTRAL ACCESS IN THE LEFT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 7MM WITH NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 4.5+1. SYSTOLIC BP WAS 130 AND ACT WAS 238. HEPARIN WAS GIVEN DURING THE PROCEDURE. THE ENTIRE MANTA WAS REMOVED DURING THE CUTDOWN AND THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 21857018 ↗
• MalfunctionApr 10, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "POST TAVR PROCEDURE, PHYSICIAN MET SEVERE RESISTANCE WHILE ATTEMPTING TO ADVANCE THE MANTA BYPASS TUBE THROUGH THE VALVE OF THE MANTA SHEATH. SEVERAL ATTEMPTS WERE MADE TO ADVANCE. MANTA SHEATH WAS REMOVED AND A NEW SECOND MANTA SHEATH WAS PLACED. SUCCESSFUL DEPLOYMENT WITH THE SECOND MANTA DEVICE." ADDITIONAL INFORMATION: "ACCESS WAS IN THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 7MM WITH NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 6+1 AND THE TIME TO HEMOSTASIS WAS IMMEDIATE POST DEPLOYMENT OF THE SECOND MANTA. THERE WAS NO REPORTED PATIENT HARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21811882 ↗
• InjuryMar 20, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "PATIENT WAS UNDERGOING A TAVR 26MM VALVE INSIDE AN 18F SHEATH. SIZING SHEET SHOWED CA++ POSTERIOR/MEDIAL AT THE MID-DISTAL 1/3 OF R FEMORAL HEAD AND DIAMETER ~7MM. DR. (---) USED AN 8F MEASURING TOOL TO GET JUST OVER 6MM (+1). TAVR WAS PERFORMED, MANTA WAS INTRODUCED AND AT JUST OVER 7CM WAS DEPLOYED, AND A 1 MINUTE TIMER WAS SET TO CINCH THE BLUE COLLAR AND KEPT PRESSURE ON DEVICE AT GREEN/RED. ANGIO WAS PERFORMED TO SHOW PARTIAL OCCLUSION; VASCULAR WAS BROUGHT IN TO ASSESS AND DECISION WAS MADE TO CUT DOWN AND REPAIR THE RFA WITH ENDARTERECTOMY. REPAIR WAS SUCCESSFULLY PERFORMED AND PATIENT HAS NO CLINICAL SEQUELA".

  Patient problems: Obstruction/Occlusion

  MAUDE report 21650386 ↗
• DeathFeb 24, 2025Break; Malposition of Device; Break; Malposition of Device

  IT WAS REPORTED THAT: "PHYSICIAN BROKE SUTURE LINE DURING DEPLOYMENT AND PUSHED COLLAGEN IN VESSEL. THE OPERATOR PULLED BACK THE MANTA DEVICE AFTER WITH EXCESSIVE FORCE AND THE SUTURE BROKE. THE VESSEL WAS PTA (BALLOON INFLATIONS) AND PLACEMENT OF A BMS (BARE METAL STENT). POST ANGIOGRAM REVEALED PATENT BLOOD FLOW." ADDITIONAL INFORMATION: "DURING AN ECMO ARTERIAL DECANNULATION PROCEDURE. MICRO PUNCTURE AND ULTRASOUND WERE UTILISED TO GAIN ACCESS IN THE LEFT COMMON FEMORAL ARTERY. VESSEL SIZE WAS >7.5MM WITH NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 5+1=6. POST MANTA DEPLOYMENT TIME TO HAEMOSTASIS WAS 15 MINUTES. SYSTOLIC BP WAS 105/55MMHG. ACT WAS 189. THERE WAS NO REPORTED PATIENT HARM. THEY WERE REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444258 ↗
• InjuryFeb 19, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT: "MANTA 18F DEPLOYED TO RIGHT FEMORAL ARTERY POST TAVR PROCEDURE. UPON SELECTIVE CONTRAST INJECTION TO RIGHT FEMORAL ARTERY, COMPLETE OCCLUSION NOTED AT DEPLOYMENT SITE OF MANTA. CT SURGEON PERFORMED A CUTDOWN TO RIGHT FEMORAL ARTERY. UPON CUTTING OUT MANTA CLOSURE DEVICE, THE SUTURE, RADIOPAQUE MARKER AND COLLAGEN WERE RETRIEVED, BUT THE FOOTPLATE WAS NOT OBTAINED. PHYSICIAN REPAIRED VESSEL AND DISTAL PULSES WERE PRESENT VIA DOPPLER TO RIGHT LOWER EXTREMITY." ADDITIONAL INFORMATION: " UPON THE CUT DOWN, THE COLLAGEN APPEARED TO BE DEPLOYED EXTRA VASCULAR PER THE CT SURGEON."

  Patient problems: Obstruction/Occlusion

  MAUDE report 21409920 ↗
• InjuryFeb 18, 2025Obstruction of Flow; Malposition of Device; Obstruction of Flow; Malposition of Device

  IT WAS REPORTED THAT "MANTA 18F CLOSURE WAS USED BY PHYSICIAN PER IFU AND PATIENT DEVELOPED COLD LEG WHILE IN RECOVERY. THE EVENT OCCURRED IN POST-OP RECOVERY. VASCULAR SURGERY WAS REQUIRED TO DETERMINE WHY THERE WAS NO BLOOD FLOW TO THE LEG."

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 21406424 ↗
• InjuryFeb 14, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "SURGEON SHARED 3 CASES WHICH MANTA FAILED. 2 CUT DOWN AND ONE STENT." ASSOCIATED COMPLAINTS 3010252479-2025-00009 AND 3010252479-2025-00010."

  Patient problems: Insufficient Information

  MAUDE report 21383345 ↗
• InjuryFeb 14, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "SURGEON SHARED 3 CASES WHICH MANTA FAILED. 2 CUT DOWN AND ONE STENT." ASSOCIATED COMPLAINTS 3010252479-2025-00008, 3010252479-2025-00009 AND 3010252479-2025-00010."

  Patient problems: Insufficient Information

  MAUDE report 21383233 ↗
• InjuryFeb 6, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT: "MANTA DEPLOYED INSIDE VESSEL AND CUTDOWN PERFORMED TO REMOVE MANTA AND CLOSE VESSEL."

  Patient problems: Obstruction/Occlusion

  MAUDE report 21320033 ↗
• MalfunctionJan 6, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "PARTIAL OCCLUSION AT LEVEL OF CLOSURE SITE CAUSED BY DISSECTION FLAP. HAD TO DO BALLOON INFLATION X 2MIN. FLOW RESTORED." ADDITIONAL INFORMATION : "DURING A TAVR PROCEDURE, MICRO PUNCTURE AND ULTRASOUND WERE USED TO GAIN CENTRAL ACCESS IN THE COMMON FEMORAL ARTERY. VESSEL SIZE WAS 5CM. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080085 ↗
• MalfunctionDec 13, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT: "POST TAVR PROCEDURE, MANTA SHEATH WAS INSERTED. PHYSICIAN MET SEVERE RESISTANCE ADVANCING BYPASS TUBE THROUGH THE MANTA SHEATH VALVE. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE BYPASS TUBE TO THE SHEATH VALVE IN ORDER TO ADVANCE THE HANDLE DOWN TO THE SHEATH. FINALLY, THE MANTA WENT THROUGH THE VALVE OF THE SHEATH. HE THEN MET SEVERE RESISTANCE TO SNAP THE MANTA DEVICE TO THE MANTA SHEATH. SEVERAL ATTEMPTS WERE MADE TO FORCIBLY SNAP THE TWO PIECES TOGETHER BUT ULTIMATELY WERE UNSUCCESSFUL. THE UNIT WAS REMOVED INTACT AND BAGGED TO BE SENT BACK FOR INVESTIGATION. A NEW MANTA SHEATH AND DEVICE WERE INSERTED AND DEPLOYED WITHOUT ISSUES. NO MEDICAL INTERVENTION REQUIRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924507 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT: NO/DIMINISHED BLOOD FLOW DISTAL FROM DEPLOYMENT SITE. SURGICAL CUT DOWN/REPAIR PERFORMED. PHYSICIAN NOTED THAT DEVICE APPEARED TO BE DEPLOYED CORRECTLY WITH NO COLLAGEN INSIDE THE VESSEL. PHYSICIAN BELIEVES THAT A POSSIBLE DISSECTION OR CALCIUM FLAP MAY HAVE GOTTEN CAUGHT ON THE ANCHOR FOOTPLATE AND WAS LIFTED, THUS BLOCKING BLOOD FLOW DISTAL TO THE DEPLOYMENT SITE. MANTA DEVICE WAS EXPLANTED AND VESSEL WAS SURGICALLY CLOSED. ADDITIONAL INFORMATION: "ULTRASOUND WAS UTILIZED TO GAIN CENTRAL ACCESS IN THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 10-11MM WITH MILD POSTERIOR AND MEDIAL CALCIFICATION. MEASURED DEPTH FOR THE MANTAQ WAS 3+1=4. SYSTOLIC BLOOD PRESSURE WAS 135MMHG. 6K HEPARIN AND 20MG OF PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE POST THE PROCEDURE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 20878677 ↗
• InjuryDec 9, 2024Malposition of Device; Failure to Seal; Malposition of Device; Failure to Seal

  IT WAS REPORTED THAT: "POSSIBLE DISSECTION AND COLLAGEN INSIDE VESSEL POST DEPLOYMENT." AI RECEIVED ON (B)(6) 2024: "MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN CENTRAL ACCESS IN THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 6.1MM WITH MODERATE, DISTAL POSTERIOR CALCIUM. MEASURED DEPTH FOR THE MANTA WAS 6.5+1=7.5. BLOOD PRESSURE WAS 118/45 AND BOTH HEPARIN AND PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. THE PATIENT HAD A SURGICAL CUT-DOWN POST MANTA CLOSURE TO RESOLVE REDUCED FLOW IN THE ARTERY, BUT DUE TO THE PATIENT'S ANATOMY, THE CARDIAC THORACIC SURGEON DECIDED TO LEAVE THE MANTA IMPLANTED AND PLACE A PERIPHERAL STENT PERCUTANEOUS THROUGH A CONTRALATERAL ACCESS. FLOW WAS RESTORED AFTER THE PTA BALLOON AND STENT WAS PLACED. NO REPORT OF ANY PATIENT HARM OR HEALTH CONSEQUENCES.".

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 20877091 ↗
• InjuryNov 25, 2024No Flow; No Flow

  IT WAS REPORTED THAT: "MANTA DEPLOYED PER IFU. POST ANGIOGRAM REVEALED NO FLOW BELOW THE MANTA DEVICE. SURGICAL CUTDOWN WAS PERFORMED AND THE MANTA WAS REMOVED INTACT." ADDITIONAL INFORMATION: "THE ISSUE OCCURRED DURING AN EVAR PROCEDURE. MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN A HIGHER ACCESS IN THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 7MM AND THE ULTRASOUND SHOWED SOME POSTERIOR CALCIUM, SO HE GAINED ACCESS ABOVE THAT CALCIUM. AT THE ACCESS SITE, NO CALCIUM WAS NOTED ON ULTRASOUND BUT ONCE HE HAD A VISUAL OF THE OPEN VESSEL, HE NOTICED SOME SIDE WALL CALCIUM THAT DID NOT SHOW UP ON ULTRASOUND. MEASURED DEPTH FOR THE MANTA WAS 3.5CM AND IT WAS DEPLOYED AT 4.5CM. IT WAS TIGHT TO ADVANCE BOTH THE PROCEDURAL AND MANTA SHEATHS. SYSTOLIC BLOOD PRESSURE WAS WITHIN NORMAL LIMITS. ACT WAS 330 SECONDS DURING THE PROCEDURE AND 230 SECONDS AT THE TIME OF THE MANTA DEPLOYMENT. 7500 UNITS OF HEPARIN AND 75 OF PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. POST OP THE PATIENT WAS STABLE AND TRANSPORTED TO PACU PER STANDARD PROTOCOL."

  Patient problems: Obstruction/Occlusion

  MAUDE report 20770072 ↗
• InjuryNov 19, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "JUST NOTIFIED OF VASCULAR COMPLICATION, PATIENT DEVELOPED FOOT DROP (R) POST OP IMMEDIATE OR POD 1. ON POD 2 DEVELOPED ACUTE LIMB ISCHEMIA (R). UNDERWENT THROMBECTOMY ON 10/18 (R)SFA UNDERWENT HEMATOMA EXCAVATION ON 10/20."

  Patient problems: Ischemia; Reduced Blood Flow

  MAUDE report 20721565 ↗
• InjuryOct 30, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT: "FOOTPLATE GOT WEDGED INTO THE VESSEL AND WHEN THE PHYSICIAN WAS TRYING TO GET A WIRE PAST TO BALLOON HE CAUSED A DISSECTION AND A PERFORATION. CUTDOWN WAS PERFORMED AND A PATCH WAS PLACED." ADDITIONAL INFORMATION RECEIVED ON 18OCT2024: "MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN ACCESS IN THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 8MM WITH NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 6+1CM. BOTH HEPARIN AND PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. THE DISSECTION WAS CAUSED BY THE PHYSICIAN TRYING TO GET A WIRE PAST WHERE THE OBSTRUCTION WAS - WHICH THE OBSTRUCTION WAS CAUSED BY THE FOOT PLATE. THE OBSTRUCTION WAS THE MANTA FOOT PLATE THAT WAS NOT FLUSH AGAINST THE ARTERIOTOMY."

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 20568400 ↗
• InjuryOct 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "CUSTOMER NOTIFIED ME THAT THE 8 FR DEPTH LOCATOR BROKE OFF DURING INSERTION AND THE BROKEN PIECE COULD NOT BE RETRIEVED. THE PATIENT WAS REPORTED AS FINE."

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20461587 ↗
• InjuryOct 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "SUPPORTING TEVAR CASE. MANTA WAS MEASURED, DEPLOYED, WHILE PULLING TO TENSION ALL PARTS CAME OUT". ADDITIONAL INFORMATION: "ULTRASOUND WAS UTILIZED TO GAIN LOW ACCESS AT BIFURCATION IN THE RIGHT COMMON FEMORAL ARTERY. MEASURED DEPTH FOR THE MANTA WAS 2+1CM. SYSTOLIC BLOOD PRESSURE WAS 150MMHG. BOTH HEPARIN AND PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. PULSATILE ARTERIAL BLEEDING WAS PRESENT POST DEPLOYMENT. CUT DOWN PREFORMED AND ALL PIECES OF MANTA HAD BEEN REMOVED DURING THE DEPLOYMENT FOOTPLATE COLLAGEN AND SUTURE WITH RADIOPAQUE LOCK INTACT UPON INSPECTION."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20461489 ↗
• InjuryOct 16, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "MANTA DEPLOYED PER IFU IN RIGHT FEMORAL ARTERY POST EVAR PROCEDURE. UPON ASSESSMENT OF TIBIAL AND PEDAL PULSES, PULSES WERE ABSENT ON RIGHT FOOT. ULTRASOUND PERFORMED, FLOW TO VESSEL WAS LIMITED DISTAL TO MANTA CLOSURE DEVICE. PHYSICIAN PROCEEDED WITH CUTDOWN TO REPAIR VESSEL, GRAFTED VESSEL SUTURED IN PLACE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 20459636 ↗
• MalfunctionOct 9, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "POST MANTA DEPLOYMENT THERE WAS NOTICEABLE SLOW IN FLOW POST ANGIOGRAM WITH SLIGHT BLUSHING. PATIENT WAS POST TAVR VALVE SIZE 20 WITH 14F SHEATH REMOVAL. SHEATH WAS "TIGHT" PER PROVIDER GOING IN. ARTERY WAS 7.1MM RIGHT FEMORAL ARTERY. MICRO PUNCTURE AND ULTRA SOUND USED FOR ACCESS. SINGLE STICK TO RIGHT FEMORAL ARTERY MID FEMORAL HEAD. DEPTH WAS 3+1CM. PATIENT WEIGHT WAS 41.7KG. MILD TORTUOSITY, WITH MILD POSTERIOR CALCIFICATION. DIRECT PRESSURE WAS HELD. WHILE LEFT SHEATH EXCHANGED FOR LONG 6F SHEATH. WIRE AND BALLOON ADVANCED AND SITE ANGIOPLASTY. POST ANGIOGRAM HAD TIMI 3 FLOW AND NO BLUSHING. SBP 120'S/60'S-70'S PRIOR TO DEPLOYMENT. ACT PRE VALVE DEPLOYMENT WAS 269. 5000 UNITS HEPARIN AND 50MG PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Extravasation; Obstruction/Occlusion

  MAUDE report 20406001 ↗
• InjuryOct 9, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT "THE MANTA DEPTH LOCATOR SPLIT IN HALF TRYING TO REMOVE FROM THE VESSEL AFTER DEPTH LOCATION DUE TO SEVERE SCAR TISSUE LEFT FROM A HIP REPLACEMENT." ADDITIONAL INFORMATION: "DURING A TAVR PROCEDURE, MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN CENTRAL ACCESS IN THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 8MM WITH MILD CALCIFICATION. THE MANTA WAS NOT USED ON THIS PATIENT. THE DEPTH LOCATOR BROKE IN HALF AND SO WE WERE NOT ABLE TO USE THE PRODUCT. WE HAD TO RETRIEVE THE DISTAL HALF OF THE DEPTH LOCATOR THAT WAS IN THE PATIENT. THIS RESULTED IN A CUT DOWN."

  Patient problems: Insufficient Information

  MAUDE report 20405999 ↗