MANTA 18F
Report
- Report Number
- 3010252479-2023-00243
- Event Type
- Injury
- Date Received
- September 19, 2023
- Date of Event
- September 12, 2023
- Report Date
- September 12, 2023
- Manufacturer
- ESSENTIAL MEDICAL, INC.
- Product Code
- MGB
- UDI-DI
- 00856279007062
- PMA / PMN Number
- P180025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#(B)(4).
(B)(4). THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. NO RETURN PRODUCT EVALUATION COULD BE COMPLETED. ANGIOGRAM VIDEO WAS OBTAINED BY VSI/ TELEFLEX INDICATING THE RADIOPAQUE LOCK POSITIONED BELOW THE FEMORAL HEAD, IN THE TISSUE TRACT. THE DEVICE LOT HISTORY RECORD REVIEW FOR LOT NUMBER MN2201490 MANTA 18F INDICATED NO NON-CONFORMITIES RELATED TO THIS LOT, THEREFORE, SUPPORTING THE DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS BEFORE SHIPMENT. CASE DETAILS WERE REVIEWED. AN 86-YEAR-OLD MALE PATIENT (BMI WITHIN ACCEPTABLE RANGE) PRESENTED TO THE OR FOR A TAVI PROCEDURE. A CENTRALLY POSITIONED ACCESS WAS GAINED UTILIZING ULTRASOUND GUIDANCE WITH A MICRO PUNCTURE KIT. THE RIGHT COMMON FEMORAL ARTERY (RCFA) WAS 10.8MM, WITH MODERATE CALCIFICATION DISTAL TO THE ACCESS, MEDIAL WALL CALCIFICATION, AND TORTUOSITY IN THE ILIAC, WITH A MEASURED DEPTH OF 2.0CM + 1CM. NO ISSUES WERE ENCOUNTERED ADVANCING OR WITHDRAWING THE 16F PROCEDURAL SHEATHS. FOLLOWING THE TAVI, AN 18F MANTA WAS DEPLOYED TO THE MEASURED DEPTH. DURING THE DEPLOYMENT, WHILE WITHDRAWING THE MANTA CLOSURE DEVICE TO YELLOW/GREEN IN THE TENSION WINDOW, PULSATILE BLEEDING WAS PRESENT. THE PHYSICIAN ADVANCED THE BLUE LOCK ADVANCEMENT TUBE, AND CONTINUED THE DEPLOYMENT STEPS, ALTHOUGH PULSATILE BLEEDING CONTINUED. FOLLOWING DEPLOYMENT, IMMEDIATE MANUAL PRESSURE WAS APPLIED WHILE A SECOND PHYSICIAN OBTAINED CONTRALATERAL ACCESS FOR AN ULTRASOUND OF THE RCFA. THE ULTRASOUND INDICATED A PATENT RCFA, GOOD DISTAL PULSES, AND NO BLUSHING OR BLEEDING AROUND THE ARTERIOTOMY, HOWEVER, THE RADIOPAQUE LOCK APPEARED FAR FROM THE ACCESS. THE PATIENT BEGAN FEELING QUEASY DESPITE BEING HEMODYNAMICALLY STABLE, WITH GOOD WAVEFORM AND 99% ON PU LSE OXIMETER, AND THE ACCESS SITE WAS DRY. A CONSULT WAS CALLED IN FOR A VASCULAR SURGEON. WHILE AWAITING THE CONSULT, THE PHYSICIAN THOUGHT THE GUIDEWIRE WAS PREVENTING THE ANCHOR FROM ADVANCING INTO POSITION AND ATTEMPTED TO TIGHTEN THE ANCHOR BY REMOVING THE GU IDEWIRE, PULLING THE MANTA DEVICE AGAIN TO YELLOW/GREEN, AND RE-ADVANCING THE BLUE LOCK ADVANCEMENT TUBE. A FOLLOW-UP ULTRASOUND INDICATED NO CHANGE. THE VASCULAR SURGEON DETERMINED BEST APPROACH WAS A CUTDOWN. DURING THE SURGICAL INTERVENTION, MANTA WAS SEEN HALF IN AND HALF OUT OF THE VESSEL DUE TO THE VESSEL BEING TORN LONGITUDINALLY. THE MANTA WAS EXPLANTED, THE VESSEL REPAIRED, AND THE TOTAL TIME TO HEMOSTASIS WAS ONE HOUR. THE PATIENT DID NOT EXPERIENCE ANY HARM, INJURY, OR HEALTH CONSEQUENCE FROM THIS EVENT AND THE OUTCOME POST-PROCEDURE WAS FINE. THE PHYSICIAN MENTIONED THE ARTERIOTOMY LIKELY WAS TORN DURING THE MULTIPLE SHEATH EXCHANGES THAT OCCURRED BEFORE THE MANTA DEPLOYMENT, DUE TO THE VALVULOPLASTY REQUIRING TWICE AS MANY EXCHANGES. DISSECTIONS ARE A POTENTIAL SEQUELA IN LARGE BORE CLOSURE PROCEDURES. THEREFORE, THE ROOT CAUSE OF THE PARTIAL TRACT DEPLOYMENT IS LIKELY DUE TO THE LONGITUDINAL ARTERIAL TEAR (DISSECTION) THAT WAS LIKELY PRESENT BEFORE THE MANTA DEPLOYMENT, UNABLE TO PROVIDE STABILITY FOR THE MANTA COLLAGEN PLUG TO SEAT PROPERLY. THE IFU POSTS WARNINGS NOT TO USE MANTA IF THERE IS MARKED TORTUOSITY OF THE FEMORAL OR ILIAC ARTERY. THE FOLLOWING POTENTIAL ADVERSE EVENTS RELATED TO THE DEPLOYMENT OF VASCULAR CLOSURE DEVICES INCLUDE OTHER ACCESS SITE COMPLICATIONS LEADING TO BLEEDING, HEMATOMA, PSEUDOANEURYSM, OR ARTERIO-VENOUS FISTULA, POSSIBLY REQUIRING BLOOD TRANSFUSION, SURGICAL REPAIR, AND/OR ENDOVASCULAR INTERVENTION. POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ANY LARGE BORE INTERVENTION, INCLUDING THE USE OF THE MANTA VASCULAR CLOSURE DEVICE, INCLUDE BUT ARE NOT LIMITED TO ARTERIAL DAMAGE, LATE ARTERIAL BLEEDING, AND VESSEL LACERATION OR TRAUMA. IF BLEEDING FROM THE FEMORAL ACCESS SITE PERSISTS AFTER THE USE OF THE MANTA DEVICE, ASSESS THE SITUATION. BASED ON THE AMOUNT OF BLEEDING, USE MANUAL OR MECHANICAL COMPRESSION, APPLICATION OF BALLOON PRESSURE, PLACEMENT OF A COVERED STENT, AND/OR SURGICAL REPAIR TO OBTAIN HEMOSTASIS. THERE APPEARS TO BE NO PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DOCUMENTATION OR LABELLING. THE DER PROCESS WILL CONTINUE TO MONITOR AND INVESTIGATE ANY SIMILAR EVENTS.
IT WAS REPORTED THAT: MD IC #1 DEPLOYED MANTA AS PER IFU TO RIGHT CFA. UPON PULLING MANTA HANDLE TO YELLOW/GREEN, PULSATILE ARTERIAL FLOW NOTED BY MD IC #1. MD IC #1 THEN ATTEMPTED TO ADVANCE BLUE TUBE AND CONTINUE STEPS, BUT PULSATILE FLOW CONTINUED. MD IC #1 STATED MANTA DEPLOYMENT TACTILE FEEL AS PER USUAL DESPITE OBVIOUS BLEED. MD IC #1 THEN IMMEDIATELY APPLIED MANUAL PRESSURE. DURING THIS TIME, MD IC #2 OBTAINED CONTRA-LATERAL ACCESS, LEFT. MD IC #2, DID US OF RIGHT CFA, US SHOWED PATENT CFA AS PER MD UNDER COLOUR FLOW DOPPLER. FLUORO IMAGING DONE VIA CONTRA-LATERAL ACCESS, DEMONSTRATED ANCHOR LARGE SPACE/DISTANCE BETWEEN FROM ANTERIOR ARTERIAL WALL AS PER MD. NO BLUSHING OR OBVIOUS BLEED AROUND ARTERIOTOMY ON FLUORO AS PER MD IC #1. PATIENT STATED FEELING "QUEASY". HEMODYNAMICALLY STABLE AS PER MD AT THIS TIME. PULSE OXIMETER TO AFFECTED LIMB: GOOD WAVEFORM AND 99% AS PER MD IC #1, AND RIGHT CFA SITE CHECKED AND DRY. MD IC #1 REQUESTED VASCULAR CONSULT NONE THE LESS AS CONCERNED ABOUT DISTANCE OF ANCHOR AND ARTERIAL WALL COMPARED TO PREVIOUS MANTA CASES PERFORMED. WHILE AWAITING VASCULAR MD, MD IC #1 CHOSE TO REMOVE WIRE FROM MANTA AND ATTEMPTED TO TIGHTENED ANCHOR BY PULLING TO YELLOW/GREEN AND RE-ADVANCING BLUE TUBE AS THOUGHT WIRE WAS PREVENTING ANCHOR FROM ADVANCING FULLY INTO POSITION. AS PER MD IC #1, NO CHANGE ON REPEATED FLUORO IMAGING AFTER THIS. VASCULAR MD DETERMINED BEST TO CUT DOWN. CUT DOWN PERFORMED, MANTA ANCHOR FOUND HALF IN/HALF OUT OF VESSEL AS ARTERIOTOMY TORN LONGITUDINALLY. VESSEL REPAIRED. PATIENT REMAINED STABLE THROUGHOUT. MD IC #1 STATED ARTERIOTOMY WAS LIKELY TORN DUE TO MULTIPLE SHEATH EXCHANGE DURING TAVI PROCEDURE AS VALVULOPLASTY REQUIRED X 2 DURING TAVI.
IT WAS REPORTED THAT: MD IC #1 DEPLOYED MANTA AS PER IFU TO RIGHT CFA. UPON PULLING MANTA HANDLE TO YELLOW/GREEN, PULSATILE ARTERIAL FLOW NOTED BY MD IC #1. MD IC #1 THEN ATTEMPTED TO ADVANCE BLUE TUBE AND CONTINUE STEPS, BUT PULSATILE FLOW CONTINUED. MD IC #1 STATED MANTA DEPLOYMENT TACTILE FEEL AS PER USUAL DESPITE OBVIOUS BLEED. MD IC #1 THEN IMMEDIATELY APPLIED MANUAL PRESSURE. DURING THIS TIME, MD IC #2 OBTAINED CONTRA-LATERAL ACCESS, LEFT. MD IC #2, DID US OF RIGHT CFA, US SHOWED PATENT CFA AS PER MD UNDER COLOUR FLOW DOPPLER. FLUORO IMAGING DONE VIA CONTRA-LATERAL ACCESS, DEMONSTRATED ANCHOR LARGE SPACE/DISTANCE BETWEEN FROM ANTERIOR ARTERIAL WALL AS PER MD. NO BLUSHING OR OBVIOUS BLEED AROUND ARTERIOTOMY ON FLUORO AS PER MD IC #1. PATIENT STATED FEELING "QUEASY". HEMODYNAMICALLY STABLE AS PER MD AT THIS TIME. PULSE OXIMETER TO AFFECTED LIMB: GOOD WAVEFORM AND 99% AS PER MD IC #1, AND RIGHT CFA SITE CHECKED AND DRY. MD IC #1 REQUESTED VASCULAR CONSULT NONE THE LESS AS CONCERNED ABOUT DISTANCE OF ANCHOR AND ARTERIAL WALL COMPARED TO PREVIOUS MANTA CASES PERFORMED. WHILE AWAITING VASCULAR MD, MD IC #1 CHOSE TO REMOVE WIRE FROM MANTA AND ATTEMPTED TO TIGHTENED ANCHOR BY PULLING TO YELLOW/GREEN AND RE-ADVANCING BLUE TUBE AS THOUGHT WIRE WAS PREVENTING ANCHOR FROM ADVANCING FULLY INTO POSITION. AS PER MD IC #1, NO CHANGE ON REPEATED FLUORO IMAGING AFTER THIS. VASCULAR MD DETERMINED BEST TO CUT DOWN. CUT DOWN PERFORMED, MANTA ANCHOR FOUND HALF IN/HALF OUT OF VESSEL AS ARTERIOTOMY TORN LONGITUDINALLY. VESSEL REPAIRED. PATIENT REMAINED STABLE THROUGHOUT. MD IC #1 STATED ARTERIOTOMY WAS LIKELY TORN DUE TO MULTIPLE SHEATH EXCHANGE DURING TAVI PROCEDURE AS VALVULOPLASTY REQUIRED X 2 DURING TAVI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1596207 | MANTA 18F | VASCULAR CLOSURE DEVICE | MGB | ESSENTIAL MEDICAL, INC. | 2115 | MN2201490 | 00856279007062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | NOT REPORTED |