MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. MANTA 18F; VASCULAR CLOSURE DEVICE

Model Number 2115

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypovolemia (2243); Retroperitoneal Hemorrhage (4483)

Event Date 02/20/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).An investigation has been opened to review historical data and risk documentation.A follow up report will be submitted after investigation.

Event Description

It was reported that: the physicians deployed an 18fr manta device over a j wire.Patient had unstable blood pressure post deployment and a retroperitoneal bleed was discovered.Additional information on 10mar2023: during a tavr procedure on 20feb the cardiac tech stated that they realized the patient had a rp bleed post procedure when patient became hypotensive.Acute cardiac life support (i.E., cpr, emergency ivp medications like epinephrine, lidocaine, etc) was performed.The tech stated that 6 units of blood were given.Cpr was initiated.The patient is reported as critical post procedure.Additional information has been requested from the account.A follow up report will be submitted after receipt of this information.

Manufacturer Narrative

(b)(4).The device was not returned for investigation.No return product evaluation could be completed.The device lot number was not reported for this investigation.Based on the information submitted, following an tavr procedure, a 18f manta was deployed for closure.Post-deployment the patient's blood pressure was unstable, became hypotensive, and a retroperitoneal bleed was discovered.Cpr was initiated, advanced cardiovascular life support performed, and the patient received six units of packed blood cells.Due to no information regarding the initial and deployment procedures, patient conditions and environment, no device or angiograms submitted for investigative purposes, a root cause of the retroperitoneal bleed remains undeterminable.This physician has not completed manta training and it is unknown how many manta cases this physician has performed.No manta representative and no manta trained healthcare professional were mentioned being present for this procedure.The ifu posts caution: federal law restricts this device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in interventional catheterization procedures and who has been trained in manta device use by an authorized representative of essential medical.Precautions the manta device should only be used by a licensed physician or healthcare provider trained in the use of this device.Potential adverse events as listed in the ifu, related to the deployment of vascular closure devices include retroperitoneal bleeding, and its consequences, because of failed closure in the setting of an access above the inguinal ligament or the most inferior border of the epigastric artery (iea).

Event Description

It was reported that: the physicians deployed an 18fr manta device over a j wire.Patient had unstable blood pressure post deployment and a retroperitoneal bleed was discovered.Additional information on 10mar2023: during a tavr procedure on (b)(6) the cardiac tech stated that they realized the patient had a rp bleed post procedure when patient became hypotensive.Acute cardiac life support (i.E., cpr, emergency ivp medications like epinephrine, lidocaine, etc) was performed.The tech stated that 6 units of blood were given.Cpr was initiated.The patient is reported as critical post procedure.Additional information has been requested from the account.A follow up report will be submitted after receipt of this information.

• Brand Name: MANTA 18F
• Type of Device: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): ESSENTIAL MEDICAL, INC.; exton
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16536543
• MDR Text Key: 311213822
• Report Number: 3010252479-2023-00047
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: 00856279007062
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2115
• Device Catalogue Number: 2115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 100 KG