MANTA 18F
Report
- Report Number
- 3010252479-2025-00051
- Event Type
- Injury
- Date Received
- May 19, 2025
- Date of Event
- April 30, 2025
- Report Date
- April 30, 2025
- Manufacturer
- ESSENTIAL MEDICAL, INC.
- Product Code
- MGB
- UDI-DI
- 00856279007062
- PMA / PMN Number
- P180025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4)
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE DETAILS OF THE COMPLAINT WERE REVIEWED. IT IS LIKELY THAT THE DISSECTION OR VESSEL FACTORS CAUSED BY THE INITIAL STICK AND/OR THE E-SHEATH COULD HAVE LED TO OCCLUSION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
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."
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."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138542 | MANTA 18F | VASCULAR CLOSURE DEVICE | MGB | ESSENTIAL MEDICAL, INC. | 73E2400582 | 00856279007062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Unknown | Required Intervention | NOT REPORTED| NOT REPORTED |