MANTA 2156Recalls & reported problems

Summary

The FDA's MAUDE database contains 347 adverse event reports that list this exact device (DI 00856279007079), received between Apr 30, 2019 and Oct 9, 2025 — classified as 4 deaths, 132 injuries, 211 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (198 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 347 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2025Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT "14 FR MANTA DEVICE FAILURE DURING PERIPHERAL VENTRICULAR ASSIST DEVICE (PVAD) REMOVAL CASE. PVAD SHEATH WAS REMOVED AND EXCHANGED FOR MANTA SHEATH. SEVERE VALVE RESISTANCE WAS EXPERIENCED DURING INTRODUCTION OF MANTA DEVICE REQUIRING MORE FORCE AND EVENTUALLY THE TIP WAS DAMAGED SO ANOTHER DEVICE WAS OPENED. DURING INTRODUCTION INTO THE SAME SHEATH, THE MANTA SHEATH HUB DISMANTLED AND BROKE APART. A THIRD DEVICE WAS OPENED AND MANTA SHEATH EXCHANGED. SAME VALVE RESISTANCE WAS EXPERIENCED BUT WAS ABLE TO MANAGE AND GET THE MANTA DEVICE THROUGH AND CLICKED TOGETHER. DEPLOYMENT WENT WELL BUT SOME EXTRAVASATION WAS SEEN ON ANGIOGRAM. WENT BACK UP ON MANTA TENSION FOR RE-EXTENSION AND THE SUTURE CUT INTO THE ADVANCEMENT TUBE AND MALFUNCTIONED. AN ALTERNATIVE SUTURE MEDIATED CLOSURE DEVICE WAS DEPLOYED TO CINCH UP THE REMAINING LEAK WITH GOOD RESULTS." ASSOCIATED COMPLAINTS 3010252479-2025-00100, 3010252479-2025-00099.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23255548 ↗
• MalfunctionOct 9, 2025Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT "14 FR MANTA DEVICE FAILURE DURING PERIPHERAL VENTRICULAR ASSIST DEVICE (PVAD) REMOVAL CASE. PVAD SHEATH WAS REMOVED AND EXCHANGED FOR MANTA SHEATH. SEVERE VALVE RESISTANCE WAS EXPERIENCED DURING INTRODUCTION OF MANTA DEVICE REQUIRING MORE FORCE AND EVENTUALLY THE TIP WAS DAMAGED SO ANOTHER DEVICE WAS OPENED. DURING INTRODUCTION INTO THE SAME SHEATH, THE MANTA SHEATH HUB DISMANTLED AND BROKE APART. A THIRD DEVICE WAS OPENED AND MANTA SHEATH EXCHANGED. SAME VALVE RESISTANCE WAS EXPERIENCED BUT WAS ABLE TO MANAGE AND GET THE MANTA DEVICE THROUGH AND CLICKED TOGETHER. DEPLOYMENT WENT WELL BUT SOME EXTRAVASATION WAS SEEN ON ANGIOGRAM. WENT BACK UP ON MANTA TENSION FOR RE-EXTENSION AND THE SUTURE CUT INTO THE ADVANCEMENT TUBE AND MALFUNCTIONED. AN ALTERNATIVE SUTURE MEDIATED CLOSURE DEVICE WAS DEPLOYED TO CINCH UP THE REMAINING LEAK WITH GOOD RESULTS." ASSOCIATED COMPLAINTS: 3010252479-2025-00100, 3010252479-2025-00099.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23255220 ↗
• InjuryOct 8, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "MICRO PUNCTURE AND ULTRAOUND WERE UTIILISED TO GAIN CENTRAL ACCESS IN THE RIGHT COMMON FEORAL ARTERY. VESSEL SIZE WAS 8MM AND MEASURED DEPTH FOR THE MANTA WAS 2+1 ACT WAS 320 AT TIME OF DEPLOYMENT AND THEN 10G PROTAMINE WAS GIVEN. A HEMATOMA STARTED FORMING IMMEDIATELY UNDER THE SKIN POST MANTA DEPLOYMENT. A FEMSTOP WAS APPLIED TO TREAT HEMATOMA. 2.5 HOURS LATER THE FEMSTOP WAS REMOVED IN THE RECOVERY ROOM AND THE PATIENTS BP DROPPED. THE PATIENT CODED AND CPR WAS PERFORMED. PATIENT HAD TO COME BACK FOR RE-ACCESS ON THE OPPOSITE SIDE AND BALLOON TAMPONADE FOR 10 MINS. THEY WERE REPORTED AS FINE POST THE INCIDENT. NO BLOOD TRANSFUSION WAS NEEDED."

  Patient problems: Hematoma

  MAUDE report 23243079 ↗
• InjuryOct 6, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT "WHEN MANTA WAS DEPLOYED, WE NOTICED A LARGE AMOUNT OF BLEEDING. THE DR HELD PRESSURE FOR 10 MINUTES AND CHECKED FOR PULSES. THERE WERE PULSES AND AFTER 10 MINUTES THERE WAS NO BLEEDING. HOWEVER, THE DR DECIDED TO USE ULTRASOUND TO CHECK THE SITE AND SAW THAT THE MANTA DEVICE WAS FULLY INSIDE OF THE VESSEL. SO THEN DECIDED TO CUTDOWN AND REMOVE MANTA AND REPAIR THE ARTERY. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE." ADDITIONAL INFORMATION: DURING THE PROCEDURE, MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN LOWER ACCESS IN THE LEFT COMMON FEMORAL ARTERY. THERE WAS MILD ANTERIOR CALCIFICATION REPORTED IN THE VESSEL. MEASURED DEPTH FOR THE MANTA WAS 2.5+1. 40MG OF PROTAMINE WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23220325 ↗
• MalfunctionAug 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "POST TAVR, SUTURE-MEDIATED CLOSURE SYSTEM X 3 UTILIZED FOR CLOSURE AND THEN MANTA 14FR FOR BAILOUT PROCEDURE. FIRST 2 MANTA HAD VALVE RESISTANCE ISSUES, 3RD 14FR MANTA WAS DEPLOYED AND WORKED PROPERLY TO CLOSE THE GROIN." ASSOCIATED COMPLAINTS 3010252479-2025-00078 AND 3010252479-2025-00079.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724334 ↗
• MalfunctionAug 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "POST TAVR, SUTURE-MEDIATED CLOSURE SYSTEM X 3 UTILIZED FOR CLOSURE AND THEN MANTA 14FR FOR BAILOUT PROCEDURE. FIRST 2 MANTA HAD VALVE RESISTANCE ISSUES, 3RD 14FR MANTA WAS DEPLOYED AND WORKED PROPERLY TO CLOSE THE GROIN." ASSOCIATED COMPLAINTS 3010252479-2025-00079.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724323 ↗
• MalfunctionJul 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "POST PERIPHERAL VENTRICULAR ASSIST DEVICE (PVAD) REMOVAL, PHYSICIAN MET SEVERE RESISTANCE ADVANCING THE BYPASS TUBE THROUGH THE VALVE OF THE MANTA SHEATH. THE MANTA DEVICE WOULD NOT ADVANCE AT ALL INTO THE MANTA SHEATH. PHYSICIAN REMOVED THE FIRST MANTA SHEATH AND OPENED A SECOND MANTA. THE ACCESS SITE WAS SUCCESSFULLY CLOSED WITH THE SECOND MANTA DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518003 ↗
• InjuryJul 8, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "DURING A TAVR HEART VALVE PROCEDURE, MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN CENTRAL ACCESS IN THE RIGHT COMMON FEMORAL ARTERY. AT THE END OF THE PROCEDURE A SUTURE MEDIATED CLOSURE DEVICE FAILED RESULTING IN THE USE OF 14 FR MANTA. THERE WAS STILL BLEEDING AROUND THE MANTA SO A COVERED STENT WAS PLACED. THERE WAS NO REPORTED PATIENT HARM AND THEY WERE REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22434464 ↗
• MalfunctionJun 16, 2025Material Twisted/Bent; Physical Resistance/Sticking; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "THE PHYSICIAN DECIDED TO REMOVE PVAD PERIPHERAL VENTRICULAR ASSIST DEVICE BEDSIDE AND UTILIZE MANTA TO CLOSE ACCESS SITE. THE REPORTED 14FR MANTA DEVICE HAD VALVE RESISTANCE AND ANCHOR INTERACTION AND FAILED TO CLICK TOGETHER. BYPASS TUBE WAS BUCKLING DUE TO RESISTANCE. AN 18 FR MANTA WAS THEN UTILIZED AND DEPLOYED SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210830 ↗
• InjuryJun 13, 2025Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT: "MANTA DEPLOYED DURING EVAR CASE. LEFT SIDED MANTA TO CLOSE A 12F SHEATH. VESSEL WAS 7.6MM AND CALCIFIED. POST DEPLOYMENT THERE WAS EXCESSIVE BLEEDING. MANTA "REDEPLOYED" AT STEEPER ANGEL. NO CHANGE IN BLEEDING. ANGIO TAKEN BUT DUE TO BLEEDING PHYSICIAN WAS UNABLE TO REMOVE PRESSURE FROM ACCESS SITE. MD MADE DECISION TO HOLD MANUAL PRESSURE FOR 40 MINUTES TOTAL. POST PRESSURE THERE WAS NO BLEEDING PRESENT, NO HEMATOMA, AND DOPPLER DISTAL PULSE TO ACCESS SITE. CHECK ON PATIENT ON (B)(6) 2025 SITE APPEARED WITHIN NORMAL LIMITS. BLOOD PRESSURE WAS 90S/60S. THERE WAS REPORTEDLY TORTUOSITY IN ILIAC BILATERALLY. MEASURED DEPTH FOR MANTA WAS 2.5+1. 4000 UNITS OF HEPARIN AND 50MG OR PROTAMINE WAS GIVEN DURING THE PROCEDURE. THE PATIENT NEEDED 1 UNIT OF BLOOD TRANSFUSED. RECEIVED MESSAGE TODAY EXPLAINING THAT THE LEFT FOOT HAD BECOME MOTTLED AND PATIENT TAKEN TO OR. MANTA REMOVED FROM WITHIN ARTERY. SECONDARY PROCEDURE TO REMOVE MANTA OCCLUSION ON (B)(6) 2025. ADDITIONAL INFORMATION: FOLLOWING AN EVAR PERFORMED ON (B)(6) 2025 A TELEFLEX MANTA CLOSURE DEVICE WAS INSERTED INTO THE LEFT COMMON FEMORAL ARTERY, WITH THE PATIENT HAVING HEAVILY CALCIFIED VESSELS THE FOOTPLATE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Reduced Blood Flow

  MAUDE report 22201499 ↗
• InjuryApr 2, 2025Premature Activation; Premature Activation

  IT WAS REPORTED THAT " THERE WAS PRE DEPLOYMENT OF FOOT PLATE WHILE LOADING THE DEVICE OVER WIRE." PER AI RECEIVED ON 12MAR2025: "DURING A TAVR PROCEDURE, ACCESS WAS GAINED IN THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 5.7MM WITH NO REPORTED CALCIFICATION. MEASURED DEPTH FOR THE MANTA WAS 3.5CM. SYSTOLIC BP WAS 130MMHG. ACT WAS 186. HEMOSTASIS WAS NOT ACHIEVED, AND VASCULAR DOCTOR WAS CALLED TO DO THE OPEN REPAIR."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21750947 ↗
• InjuryFeb 19, 2025Obstruction of Flow; Obstruction of Flow

  THE REPORT STATES: "14F MANTA VASCULAR CLOSURE DEVICE WAS DEPLOYED IN LEFT FEMORAL ACCESS SITE. POST DEPLOYMENT PEDAL PULSES WERE ABSENT UNDER DOPPLER EXAM. PERIPHERAL ANGIOGRAPHY REVEALED DISTAL DISSECTION AND EVIDENCE OF THROMBI. CARDIOVASCULAR OPERATING ROOM AND VASCULAR SURGERY NOTIFIED AND IN ROOM FOR INTERVENTION."

  Patient problems: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 21409183 ↗
• MalfunctionNov 19, 2024Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "MANTA DEVICE COMPLETELY CAME OUT OF PATIENT WHEN TRYING TO DEPLOY. PHYSICIAN USED A NEW MANTA AND ADDED 1CM AND DEPLOYMENT WAS SUCCESSFUL." AI RECEIVED ON 01NOV2024: "SEVERE RESISTANCE WAS EXPERIENCED WITH ADVANCEMENT OF THE MANTA BYPASS TUBE INTO THE MANTA SHEATH. IT WAS ALSO REPORTED THAT THERE WAS BUCKLING AND BENDING OF THE BYPASS TUBE. AI RECEIVED ON 07NOV2024: IT WAS CONFIRMED THAT THERE WAS KINKING OF THE FIRST BYPASS TUBE WHEN IT MET RESISTANCE. WHEN THE MANTA COMPLETELY PULLED OUT OF THE PATIENT, THE ANCHOR WAS INSIDE THE SHEATH. THE PATIENT EXPERIANCE NO HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723283 ↗
• MalfunctionOct 8, 2024Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "DURING A PCI / IMPELLA REMOVAL, GETTING THE BYPASS TUBE IN THE SHEATH VALVE WAS DIFFICULT, THE DOCTOR WAS ABLE TO CLICK TO CLOSURE UNIT INTO THE SHEATH WITH MORE FORCE THAN USUAL. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395932 ↗
• MalfunctionOct 8, 2024Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking; Failure to Advance; Material Twisted/Bent; Physical Resistance/Sticking

  IT WAS REPORTED THAT "SHEATH ADVANCED SMOOTHLY ON SUPER CORE WIRE. 14F MANTA DEVICE ADVANCED OVER WIRE. BYPASS TUBE WOULD NOT FULLY ENGAGE INTO VALVE OF SHEATH. DEVICE BECAME KINKED IN TWO AREAS. ADVISED IT BE REMOVED AND REPLACED. SECOND MANTA DEVICE USED SAME LOT NUMBER WITH NO CONCERNS. DEPLOYED WITH HEMOSTASIS ACHIEVED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20395222 ↗
• InjuryJul 15, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT: "EXTRAVASATION ON POST ANGIO, HELD PRESSURE FOR 1 HR. PT WENT TO SURGERY FOR CUTDOWN." ADDITIONAL INFORMATION: MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN ACCESS IN THE TOP 1/3 OF FEMORAL HEAD OF THE RIGHT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 5MM WITH MODERATE MEDIAL AND POSTERIOR CALCIFICATION AND NO REPORTED TORTUOSITY. MEASURED DEPTH FOR THE MANTA WAS 6+1=7CM. HEPARIN WAS ADMINISTERED DURING THE PROCEDURE AND NO PROTAMINE WAS GIVEN. AFTER THE CUTDOWN THE MANTA WAS FOUND IN THE TRACT AND WAS EXPLANTED. THE PATIENT WAS REPORTED AS FINE AFTER THE PROCEDURE.

  Patient problems: Extravasation

  MAUDE report 19738400 ↗
• MalfunctionMay 2, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT "COULD NOT PUSH THE MANTA THROUGH THE VALVE". ADDITIONAL INFORMATION: DURING AN PERCUTANEOUS VENTRICULAR ASSIST DEVICE PVAD 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. WHEN THEY WERE UNABLE TO PUSH THE MANTA TROUGH THE VALVE ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED AS FINE. ASSOCIATED COMPLAINTS: 3010252479-2024-00064 AND 3010252479-2024-00065.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228216 ↗
• MalfunctionMay 2, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT "COULD NOT PUSH THE MANTA THROUGH THE VALVE". ADDITIONAL INFORMATION: DURING AN PERCUTANEOUS VENTRICULAR ASSIST DEVICE PVAD 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. WHEN THEY WERE UNABLE TO PUSH THE MANTA TROUGH THE VALVE ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THER PATIENT WAS REPORTED AS FINE. ASSOCIATED COMPLAINTS: 3010252479-2024-00064 AND 3010252479-2024-00065.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228185 ↗
• InjuryMay 2, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT: "HEMOSTASIS WAS NOT OBTAINED. PHYSICIAN PERFORMED SURGICAL CUTDOWN, REMOVED MANTA CLOSURE DEVICE AND CLOSED VESSEL ACCESS SITE." ADDITIONAL INFORMATION: DURING AN EVAR PROCEDURE, MICRO PUNCTURE AND ULTRASOUND WERE UTILISED TO GAIN ACCESS IN THE RIGHT COMMON FEMORAL ARTERY. ACCESS WAS DESCRIBED AS CENTRAL CFA BUT SIDEWALL STICK (MEDIAL ON THE VESSEL RATHER THAN ANTERIOR). VESSEL SIZE WAS >8MM WITH MILD POSTERIOR CALCIFICATION AND NO REPORTED TORTUOSITY. BLOOD PRESSURE WAS 127/49MMHG PRIOR TO CLOSURE. HEPARIN 5000UNITS AND AN UNKNOWN AMOUNT OF PROTAMINE WERE ADMINISTERED DURING THE PROCEDURE. AS PER THE PHYSICIAN - MANTA WAS DEPLOYED ON MEDIAL SIDE OF VESSEL INSTEAD OF ANTERIOR. THE COLLAGEN WAS NOT DEPLOYED IN THE VESSEL; THE FOOTPLATE WAS CAUGHT ON PLAQUE AND DID NOT FULLY OPPOSE TO THE VESSEL WALL; THE COLLAGEN WAS ON TOP OF THE VESSEL; THERE WAS PULSATILE BLOOD FLOW AT THE END OF THE PROCEDURE. MANTA ANCHOR NOT POSITIONED CORRECTLY. CUT DOWN WAS PERFORMED AND THE MANTA WAS REMOVED. THE PATIENT WAS REPORTED AS FINE AND THERE WAS NO REPORTED PATIENT HARM POST THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19227970 ↗
• InjuryApr 30, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED "BLEEDING FROM FEMORAL ACCESS POST MANTA CLOSURE. A BALLOON AND COVERED STENT WAS USED FOR HEMOSTASIS"THERE WAS NO OTHER PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19214974 ↗
• InjuryApr 23, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED "MANTA DEVICE DEPLOYED IN TISSUE TRACT FAILURE TO OBTAIN HEMOSTASIS". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164450 ↗
• MalfunctionApr 4, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT: "THE MANTA WOULD NOT ADVANCE THROUGH SHEATH." THE ISSUE WAS IDENTIFIED DURING USE ON PATIENT. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040458 ↗
• MalfunctionApr 2, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT: DEVICE IN QUESTION WOULD NOT ADVANCE THROUGH THE VALVE. JUST GOT STUCK ON THE VALVE. ADDITIONAL INFORMATION: DURING A PCI PROCEDURE. THERE WAS NO ISSUE ADVANCING OR WITHDRAWING THE SHEATHS. THERE WAS NO REPORTED OF PATIENT HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19017917 ↗
• MalfunctionMar 27, 2024Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT: "UNABLE TO GET MANTA DEVICE THROUGH THE MANTA VALVE. ENTIRE DEVICE WAS DISCARDED AND SUCCESSFULLY USED A NEW DEVICE." ADDITIONAL INFORMATION: THE CASE WAS AN EVAR. THE MANTA WAS USED TO CLOSE THE LEFT CFA. SEVERE RESISTANCE WAS MET WHEN ATTEMPTING TO PASS THE DEVICE THROUGH THE SHEATH. THE PATIENT WAS REPORTED AS FINE POST THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985089 ↗
• InjuryMar 15, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT: 14FR MANTA USED DURING TAVR ON (B)(6) 2024 ON A CFA WITH 5.5 DIAMETER. PER VERBAL COMMUNICATIONS WITH THE SITE RESEARCH COORDINATOR AND REP, THE PUNCTURE SITE PROBABLY WAS STRETCHED DURING THE PROCEDURE AND THE MANTA DEVICE PULLED OUT OF THE ARTERY TO THE SUBCUTANEOUS TISSUE TRACT. THE PATIENT WENT THROUGH SURGICAL CUTDOWN. THIS IS BEING REPORTED FOR THE STUDY AS AN ADVERSE EVENT AND A DEVICE DEFICIENCY. ADDITIONAL INFORMATION RECEIVED ON 21FEB2024: PULSATILE BLOOD FLOW FROM GROIN. THE MANTA FOOTPLATE/COLLAGEN AND LOCK WERE IN THE TISSUE TRACK NOT THE VESSEL. THIS WAS DISCOVERED DURING THE CUTDOWN. ADDITIONAL INFORMATION: MICRO PUNCTURE AND ULTRASOUND WERE UTILIZED TO GAIN ACCESS IN THE LEFT COMMON FEMORAL ARTERY. VESSEL SIZE WAS 5.5 PER EDC 5.6MM. MEASURED DEPTH FOR THE MANTA WAS 3 + 1 =4. SBP WAS 136MMHG AND ACT WAS 175 PRIOR TO CLOSURE. 13000 UNITS OF HEPARIN AND 25 MG OR PROTAMINE WERE ADMINISTERED. HEMOSTASIS WAS NOT ACHIEVED UNTIL THE CUTDOWN 57 MINUTES AND 34 SECONDS AFTER DEPLOYMENT. SUCCESSFUL CUTDOWN AND CASE WAS COMPLETED AND THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE FROM THE INCIDENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18910577 ↗