MANTA 2115Recalls & reported problems

Summary

The FDA's MAUDE database contains 966 adverse event reports that list this exact device (DI 00856279007062), received between Apr 23, 2019 and Nov 3, 2025 — classified as 14 deaths, 676 injuries, 276 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (223 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 966 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT "U/S USED FOR ACCESS WITH MICRO-INTRODUCER KIT. NOTED HIGH SINGLE STICK, BUT IN THE CENTER OF FA, WHICH MEASURES 8.7MM. MD WAS NOTIFIED BY ME THAT ACCESS WAS NOT OPTIMAL, BUT CONTINUED TO MOVE FORWARD. TAVR PERFORMED THROUGH RIGHT FA WITH A 18FR SHEATH. MEDTRONIC 29MM VALVE DEPLOYED WITH NO COMPLICATIONS. 18FR MANTA DEVICE USED PER IFU AND APPEARED TO HAVE OPTIMAL RESULT WITH NO OOZING OR EXTRAVASATION. FOLLOWED UP WITH PATIENT AFTER 15 MIN AND GROIN WAS SOFT. PT MOVED TO RECOVERY WITH NO ISSUES. PT HAD RP BLEED LATE IN THE DAY IN RECOVERY. PT WAS BROUGHT BACK TO CATH LAB FOR COVERED STENT. PT IS FINE"

  Patient problems: Retroperitoneal Hemorrhage

  MAUDE report 23448121 ↗
• InjuryOct 15, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT: "DURING A TAVR PROCEDURE. MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN ACCESS IN THE LEFT COMMON FEMORAL ARTERY AT THE BOTTOM OF THE FEMORAL HEAD. MODERATE POSTERIOR CALCIFICATION WAS REPORTED. MEASURED DEPTH FOR THE MANTA WAS 4.5 CM. SYSTOLIC BLOOD PRESSURE WAS 120/55 AND ACT WAS 565. HEPARIN 7000UNITS AND 40 MG OF PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. IT WAS REPORTED THERE WAS A TRACT DEPLOYMENT. DR PULLED HARD AND FAST TO RED. LOTS OF EXTRAVASATION ON POST ANGIO. LOCK FAR AWAY FROM VESSEL. AFTER MULTIPLE BALLOON INFLATIONS AT LT CFA EXTRAVASATION CONTINUED AND VASCULAR WAS CALLED TO DO A CUTDOWN. THERE WAS NO PATIENT HARM FROM THE INCIDENT."

  Patient problems: Vascular Dissection

  MAUDE report 23298561 ↗
• MalfunctionOct 10, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "FIRST MANTA DEVICE WAS INTRODUCED INTO MANTA SHEATH VALVE WITH INCREASED RESISTANCE WHICH CAUSED IT TO BACK OUT AND AFFECTED THE TIP AND ANCHOR. ANOTHER DEVICE (SECOND MANTA) WAS OPENED AND INTRODUCED INTO THE SAME SHEATH WITH SAME RESISTANCE, BUT BYPASS TUBE WENT IN AND WAS HELD IN PLACE WITH OPERATOR'S THUMB WHILE ADVANCING THE MANTA DEVICE FULLY INTO CLICKED POSITION. FROM THERE THE MANTA WORKED AS IT SHOULD AND A GOOD CLOSE WAS NOTED. THIS COMPLAINT IS FOR THE SECOND MANTA. ASSOCIATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263940 ↗
• InjuryOct 10, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT: "DURING A TAVR PROCEDURE. MICRO PUNCTURE WAS UTILISED TO GAIN ACCESSPHYSICIAN DIDN'T COMPLETE TAKING THE BLUE LEVER BACK TO RELEASE THE FOOTPLATE AND ENDED UP HAVING THE FOOTPLATE AND COLLAGEN DEPLOY IN THE SKIN TRACT. PHYSICIAN WENT UP AND OVER WITH A BALLOON AND COVERED STENT TO COMPLETE CLOSURE. THE PHYSICIAN DECIDED TO GIVE A BLOOD TRANSFUSION IN THE ROOM DUE TO BLOOD LOSS AND TO MAKE SURE THAT THE PATIENT WAS STABLE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23263860 ↗
• MalfunctionOct 9, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT "18FR MANTA VALVE RESISTANCE DURING CLOSURE AFTER TAVR CASE WITH EDWARDS VALVE SYSTEM WHICH CAUSED IT TO BACK OUT AND AFFECTED THE TIP AND ANCHOR. THERE WAS NO HARM OR CONSEQUENCE TO THE PATIENT. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23254800 ↗
• InjuryOct 8, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "MANTA DEVICE FAILED IMMEDIATELY, TISSUE TRACT DEPLOYMENT. ADDITIONAL INFORMATION: DURING AN EVAR MICROPUNCTURE AND ULTRASOUND WERE UTILISED TO GAIN CENTRAL ACCESS IN THE COMMON FEMORAL ARTERY. VESSEL SIZE WAS 8+MM WITH NO REPROTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 2+1. 10K UNITS OF HEPARIN AND 75MG OF PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. HEMOSTASIS WAS NOT ACHIEVED AFTER MANTA WAS DEPLOYED. SURGICAL CUTDOWN WAS PERFORMED AND THE MANTA WAS EXPLANTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23242304 ↗
• InjuryOct 7, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT "DURING A TAVR PROCEDURE, FOLLOWING THE DEPLOYMENT OF THE 18F MANTA BLEEDING WAS OBSERVED. MANUAL PRESSURE WAS APPLIED FOR 20 MINUTES BUT SURGICAL INTERVENTION WAS NEEDED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23231357 ↗
• InjuryOct 6, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "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 NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 4.5+1. SYSTOLIC BLOOD PRESSURE WAS 96/50 AND ACT WAS 264. BOTH HEPARIN AND PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. FOLLOWING THE DEPLOYMENT OF THE 18F MANTA ANGIOGRAPHY SHOWED EVIDENCE OF A RIGHT COMMON FEMORAL ARTERY OCCLUSION WAS OBSERVED. A COVERED STENT WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Reduced Blood Flow

  MAUDE report 23220051 ↗
• InjurySep 19, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "CONTINUED BLEEDING FROM THE SITE POST DEPLOYMENT. POSSIBLE VESSEL DISSECTION/DAMAGE REVEALED VIA ANGIOGRAM. SURGICAL CUTDOWN/REPAIR WAS PERFORMED TO THE SITE. " ADDITIONAL INFORMATION: " MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN CENTRAL ACCESS IN THE LEFT COMMON FEMORAL ARTERY. VESSEL SIZE WAS MM WITH MODERATE CALCIFICATION AND SOME TORTUOSITY NOTED. MEASURED DEPTH FOR THE MANTA WAS 7+1=8. WHEN ATTEMPTING TO ADVANCE THE SHEATHS DURING THE PROCEDURE THEY HAD TO BE EXCHANGED MULTIPLE TIMES DUE TO DIFFICULTY TRAVERSING THE VESSEL. SYSTOLIC BLOOD PRESSURE WAS 149MMHG. ACT GREATER THAN 250 AT TIME OF DEPLOYMENT. 12 THOUSAND UNITS OF HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. TIME TO HEMOSTASIS WAS APPROXIMATELY 20 MINUTES. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE.".

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 23093537 ↗
• InjuryAug 25, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT "18 FR MANTA DEPLOYED POST EDWARDS TAVR VALVE. LARGE POST CLOSURE LEAK FROM 12MM ABOVE FEMORAL ARTERIOTOMY. COVERED STENT DEPLOYED TO SEAL LEAK WITH GOOD RESULT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884875 ↗
• InjuryJun 18, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "18FR MANTA DEPLOYED IN TAVR. NO FLOW DURING POST DEPLOYMENT , POST ANGIOGRAM REVEALING VESSEL OCCLUSION , CUTDOWN WAS PERFORMED. SUCCESSFUL CUTDOWN REVEALED COLLAGEN AND FOOTPLATE WAS IN THE VESSEL DISRUPTING FLOW. HEMOSTASIS WAS SUCCESSFUL AFTER THE CUTDOWN. PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 22282303 ↗
• MalfunctionJun 17, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "DEVICE FOOTPLATE DID NOT RELEASE WHEN BLUE LEVEL WAS FLIPPED. THE BOX WAS BRAND NEW AND WE USED 2 AND THEY BOTH DID THE SAME THING. WE HAD TO USE A DIFFERENT LOT NUMBER TO CLOSE THE GROIN. THERE WAS SEVERE RESISTANCE NOTED WHEN ATTEMPTING TO ADVANCE THE SHEATH INTO THE BYPASS TUBE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE POST THE PROCEDURE." ASSOCIATED COMPLAINT 3010252479-2025-00069.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22217494 ↗
• MalfunctionJun 17, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "DEVICE FOOTPLATE DID NOT RELEASE WHEN BLUE LEVEL WAS FLIPPED. THE BOX WAS BRAND NEW AND WE USED 2 AND THEY BOTH DID THE SAME THING. WE HAD TO USE A DIFFERENT LOT NUMBER TO CLOSE THE GROIN. THERE WAS SEVERE RESISTANCE NOTED WHEN ATTEMPTING TO ADVANCE THE SHEATH INTO THE BYPASS TUBE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE. THEY WERE REPORTED AS FINE POST THE PROCEDURE." ASSOCIATED COMPLAINTS 3010252479-2025-00070.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22217487 ↗
• InjuryJun 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "AFTER FOOTPLATE DEPLOYMENT THE DEVICE FELL APART, AND MALFUNCTIONED. DR PREFORMED SURGICAL CUTDOWN TO FIX." 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 NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 5+1CM. BOTH PROTAMINE AND HEPARIN WERE ADMINISTERED INTRAVENOUSLY DURING THE PROCEDURE. DR STATED THAT AS HE WAS PULLING TO TENSION , THE DEVICE FAILED AND CAME APART. TIME TO HEMOSTASIS WAS IMMEDIATE BUT AFTER ANGIOGRAM THEY NOTICED AN OCCLUSION AND NO DISTAL PULSES. CUT DOWN PREFORMED AND DEVICE REMOVED PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 22211811 ↗
• MalfunctionJun 16, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "DR DEPLOYED THE 18F MANTA PER IFU INSTRUCTIONS. WHEN THE POST ANGIOGRAM WAS TAKEN , WE NOTICE THE FEMORAL ARTERY WAS OCCLUDED. HE PROCEEDED TO BALLOON THE SITE WHICH RESOLVED THE ISSUE." ADDITIONAL INFORMATION: "DURING THE 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+1CM. BOTH HEPARIN AND PROTAMINE WERE ADMINISTERED INTRAVENOUSLY DURING THE PROCEDURE. NO CUT DOWN WAS PERFORMED, THE OCCLUSION WAS RESOLVED WITH A BALLOON AND THE PATIENT WAS REPORTED TO BE FINE POST THE PROCEDURE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211223 ↗
• InjuryJun 13, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "MANTA USED PER IFU. 81Y/O MALE. BMI OF 35. DEPTH LOCATION WAS 6.5+1CM. MILD POSTERIOR CALCIUM, BUT VESSEL WAS 8.9MM. ACCESS OF RCA VIA U/S. BLOOD PRESSURE 130MMHG, ACT 220. HEPARIN 10000 UNITS AND HALF DOSE PROTAMINE GIVEN PRIOR TO CLOSURE. PRE-DILATION OF AORTIC VALVE WITH 18FR SHEATH, THEN REMOVED AND PROCEDURE COMPLETED WITH MEDTRONIC INTEGRATED SYSTEM. MANTA INSERTED AND PULLED TO 7.5CM AND FULLY DEPLOYED POST PROCEDURE. BLEEDING STILL NOTED POST PROCEDURE, BUT NO HEMATOMA. UPON POST MANTA CINE, EXTRAVASATION NOTED NEAR THE MANTA DEVICE. MANUAL PRESSURE HELD AND WE WENT UP AND OVER WITH BALLOON. WITH BALLOON INFLATED, BLEEDING AT ACCESS SITE STILL NOTED. BALLOON INFLATED TO NOMINAL AND KEPT UP FOR 5 MINUTES. 2 COVERED STENTS DEPLOYED. STRONG OOZE AT ACCESS SITE STILL NOTED AND HELD PRESSURE FOR 30MIN. VASCULAR SURGEON STATED HE BELIEVED THE MANTA IS NOT THE CULPRIT AND THERE IS A VESSEL ISSUE. BLEEDING SLOWED AND PATIENT WAS TAKEN TO ICU FOR FURTHER MANUAL PRESSURE AND OBSERVATION. SOME HOURS LATER, BLEEDING STOPPED AND NO NOTED OOZING OR HEMATOMA, AND RP BLEED WAS RULED OUT. PATIENT WAS STABLE AND ON BED REST. PATIENT WAS DISCHARGED THE NEXT DAY."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22202434 ↗
• MalfunctionJun 13, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT: "LIMITED FLOW NOTED PAST THE ACCESS SITE AFTER MANTA DEPLOYMENT." ADDITIONAL INFORMATION: "DURING A TAVR, MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN ACCESS IN THE MID FEMORAL HEAD OF THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE 9.6CM. ADVANCING PROCEDURE SHEATHS DURING THE CASE WAS DIFFICULT. SHOCKWAVE WAS USED IN THE DISTAL AORTA JUST ABOVE THE BIFURCATION TO ADVANCE THE VALVE DEPLOYMENT DEVICE. CALCIFICATION AS MILD ABOVE THE ACCESS SITE. MEASURED DEPTH FOR THE MANTA WAS 8+1MM. ACT WAS 250. 18000UNITS OF HEPARIN AND 40MG OF PROTAMINE WERE GIVEN DURING THE PROCEDURE. AFTER THE OCCLUSION WAS NOTED, A BALLOON ANGIOPLASTY OF THE AREA WAS DONE AND FLOW WAS RESTORED. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 22201862 ↗
• InjuryMay 28, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "BLEEDING FROM SITE POST DEPLOYMENT. FLUORO REVEALED EXTRAVASATION FROM CLOSURE SITE." ADDITIONAL INFORMATION: "DURING A TAVR PROCEDURE, MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN ACCESS IN THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 6.2MM WITH MILD POSTERIOR CALCIFICATION. MEASURED DEPTH FOR THE MANTA WAS 4+1=5. SYSTOLIC BLOOD PRESSURE WAS 160MMHG. ACT WAS 160 PRIOR TO VALVE DEPLOYMENT AND ADDITIONAL HEPARIN WAS GIVEN. 14000 UNITS OF HEPARIN WAS ADMINISTERED INTRAVENOUSLY AND 140MG OF PROTAMINE DURING THE PROCEDURE. TIME TO HEMOSTASIS WAS 10-15 MINUTES AND THE SITE HAD TO BE TREATED WITH A 6X59 COVERED STENT AND 7X40 PERIPHERAL ANGIOPLASTY BALLOON TO ACHIEVE HEMOSTASIS. THE PATIENT WAS REPORTED AS GOOD POST THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094489 ↗
• InjuryMay 19, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT: "TAVR CASE. PHYSICIAN GOT ACCESS WITH MIK AND ULTRASOUND. PUFF OF CONTRAST SHOWED HE WAS IN A DISSECTION PLANE. REMOVED MIK, HELD PRESSURE AND RE-STUCK A SECOND TIME WITH MIK AND ULTRASOUND. PRE FEMORAL ANGIO WAS IN TRUE LUMEN, PROCEEDED WITH TAVR CASE. NO ISSUES ADVANCING SHEATHS. WHEN THE VALVE ENTERED THROUGH E-SHEATH, PATIENT BECAME IRRITABLE AND WAS IN PAIN. CONTINUED WITH THE TAVR PROCEDURE. PHYSICIAN WAS CONCERNED ABOUT THE DISSECTION FROM THE INITIAL STICK, SO HE TOOK AN ANGIO WITH THE SHEATH PULLED BACK TO THE FEMORAL. SHEATH WAS OCCLUSIVE. PHYSICIAN REMOVED E-SHEATH AND CLOSED WITH MANTA. WHEN PHYSICIAN TOOK THE ANGIO POST MANTA, THE VESSEL WAS OCCLUDED FROM ILIAC TO DISTAL TO THE MANTA CLOSURE. PHYSICIAN CONSULTED VASCULAR SURGERY. CUT DOWN WAS PERFORMED AND THE MANTA DEVICE WAS REMOVED IN ITS ENTIRETY. THE PATIENT WAS STABLE POST THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042511 ↗
• MalfunctionMay 15, 2025Material Separation; Difficult or Delayed Activation; Physical Resistance/Sticking; Material Separation; Difficult or Delayed Activation; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "DEVICE FELL APART ON DEPLOYMENT. PHYSICIAN WAS ABLE TO HOLD PRESSURE AND USE ANOTHER DEVICE AND OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION STATES THAT THERE WAS MODERATE RESISTANCE FELT WHEN ATTEMPTING TO ADVANCE THE BYPASS TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024571 ↗
• InjuryApr 2, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "SUBJECT WENT TO THE EMERGENCY ROOM ON (B)(6) 2025 FOR THE RIGHT GROIN BLEED AFTER THE PATIENT WOKE UP TO THE BANDAGE SOAKED WITH BLOOD AT THE MANTA ACCESS SITE. THE ER APPLIED PRESSURE TO THE ACCESS SITE AND CHANGED THE BANDAGE BEFORE SHE WAS DISCHARGED. LATER THAT EVENING THE SUBJECT PRESENTED AT THE ER A SECOND TIME AFTER SHE NOTED MORE BLOOD ON THE BANDAGE AT THE ACCESS SITE. BLEEDING RESOLVED THAT EVENING AFTER 2 SUTURES WERE PLACED AT THE SITE." "DATE OF TAVR: (B)(6) 2025 ULTRASOUND AND MICRO PUNCTURE WAS 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: RIGHT CFA (9.0 MM). TISSUE DEPTH RECORDED: 3.0 CM. DEPLOYMENT IS AT 4.0 CM. SITE REPORTS 0 SHEATH EXCHANGES PRIOR TO INSERTION OF THE MANTA SHEATH. SITE REPORTED NO INTRAPROCEDURAL COMPLICATION AT THE FEMORAL ACCESS SITE BEFORE PROCEDURE SHEATH REMOVAL. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. ACT WAS 141 SEC AND SYSTOLIC BP WAS 129 MMHG PRIOR TO CLOSURE. 30MG OF PROTAMINE WAS GIVEN PRIOR TO MANTA CLOSURE. MANTA EXP. DATE:

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21751916 ↗
• MalfunctionMar 26, 2025Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT: "TAVI PROCEDURE, THE MEMBRANE OF THE MANTA SHEATH WAS STIFF, AND THE MANTA CATHETER COULDN'T PENETRATE IT. THE DOCTOR HAD TO TAKE NEW DEVICE, AND THAT WAS OK." ANATOMICAL INSERTION SITE OF DEVICE: RIGHT FEMORAL ARTERY. DEVICE REMOVED AND A NEW MANTA KIT WAS USED. THERAPY DELAYED DUE TO THIS BUT NOT HARM TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696347 ↗
• MalfunctionMar 26, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT: " DURING THE TAVI PROCEDURE WHEN THE PHYSICIAN OPENED THE MANTA DEVICE, HE SAW THAT THE BYPASS TUBE WITH THE ANCHOR AND COLLAGEN INSIDE THE TUBE WENT OUTSIDE OF THE DELIVERY TUBE. HOWEVER, THE PHYSICIAN TRIED TO CONNECT THE MANTA DEVICE TO THE MANTA SHEATH, BUT WITHOUT SUCCESS. THE CONNECTION BETWEEN THE DEVICE AND SHEATH WAS IMPOSSIBLE. THEN THE PHYSICIAN DECIDED TO USE SECOND DEVICE, AND EVERYTHING FINISHED PERFECT." ADDITIONAL INFORMATION: "INSERTION OCCURRED IN THE INVASIVE CARDIOLOGY DEPARTMENT. MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN CENTRAL ACCESS. THERE WAS NO REPORTED CALCIFICATION. ANATOMICAL INSERTION SITE OF THE DEVICE: FEMORAL ARTERY. THE DEVICE KINKED DURING THE ATTEMPT. ISSUE RESOLVED BY USING ANOTHER MANTA DEVICE AND WAS SUCCESSFUL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695612 ↗
• MalfunctionMar 20, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "PARTIAL OCCLUSION OF FEMORAL ARTERY, ARTERY BALLOONED FOR 30 SECONDS AND OCCLUSION RESOLVED." ADDITIONAL INFORMATION: "DURING AN LBC PROCEDURE, MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN LOWER ACCESS IN THE COMMON FEMORAL ARTERY. THERE WAS NO REPORTED CALCIFICATION OR TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 2+1. TIME TO HAEMOSTASIS WAS IMMEDIATE. THERE WAS NO PATIENT INJURY OR CONSEQUENCE FROM THE PROCEDURE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 21650917 ↗
• InjuryMar 20, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT: "MANTA DEPTH WAS OBTAINED, PROCEDURE WENT AS EXPECTED, MANTA CLOSURE WAS PLACED, DRAWN BACK TO APPROPRIATE DEPTH, ENGAGED ANCHOR, STARTED TO PULL BACK AND PT WAS BLEEDING LIKE NORMAL COMING TO YELLOW/GREEN, MDS DIDN'T FOLLOW THE NEXT STEPS IN DROPPING BLUE TUBE AND MARKER WAS HALFWAY DOWN THE SUTURE OUTSIDE THE BODY , THEY STOPPED, HELD PRESSURE, AND GOT CLIPS AND STARTED PULLING OUT THE COLLAGEN PLUG SEARCHING FOR THE ANCHOR THAT THEY THOUGHT WAS OUTSIDE THE VESSEL. THEY TOOK AN ANGIO AND THE ANCHOR WAS IN THE VESSEL. SHEATH WAS 18FR, RFA AT 7+MM, MICRO KIT/US/HIGH BIFURCATION, MID TO UPPER 1/3 OF FEM HEAD, NO CALCIUM, MINIMAL TORTUOSITY, DEPTH 3.5+1, 11000 HEP, ACT 320, 50MG PROTAMINE, BP WAS 152/89MMHG, MANTA DEPLOYED AT CORRECT DEPTH, AS STATED BEFORE THEY DIDN'T ADVANCE THE BLUE TUBE DOWN TO COMPLETE THE COLLAGEN SANDWICH. THEY BEGAN TO GO IN WITH SURGICAL CLIPS TO ATTEMPT TO GET THE ANCHOR. THEY WERE UNABLE TO GET THE ANCHOR AND OPTED FOR A CUTDOWN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650424 ↗