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

Model Number 2115

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/20/2023

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: "had to balloon at level of manta deployment.Vessel occluded.Flow restored".Patient was reported as fine post procedure.Additional information has been requested from account.

Event Description

It was reported that: "had to balloon at level of manta deployment.Vessel occluded.Flow restored" patient was reported as fine post procedure.Additional information has been requested from account.

Manufacturer Narrative

(b)(4).The device was not returned for investigation.No return product evaluation could be completed.Angiogram photos were obtained by vsi indicating an interrupted flow posterior to the manta radiopaque lock.The radiopaque lock was situated on the lower portion of the femoral head.Balloon inflation was applied, restoring flow and a covered stent was placed.The device lot history record review indicated no non-conformities related to this lot, therefore, supporting the device met material, assembly, and performance specifications prior to shipment.Based on the information submitted, following a tavr procedure, an 18f manta was deployed for closure in the left common femoral artery (lcfa).Micropuncture and ultrasound guidance were utilized to gain a lower bottom third of the femoral head and positioned access.The arteriotomy was 7.3mm, with moderate calcification in the cfa, extreme posterior calcification in the lower extremity, and no to rtuosity, with a depth measurement of 5.0cm + 1cm.No issues were encountered advancing or withdrawing the procedural sheaths.Manta was deployed to the measured depth and following deployment, a post-angiogram revealed an occluded vessel.The physician thought the occlusion was due to a vessel dissection although the cardiologist felt it was caused either by the manta anchor being mispositioned and/or the presence of plaque.The physician applied balloon angioplasty, and the patient began violently swinging and moving on the table and bleeding occurred from the access site.The patient was re-positioned back onto the table and a covered stent was deployed restoring flow.The time to hemostasis was greater than ten minutes, and the patient outcome post-procedure was fine.The suspected root cause of the extended hemostasis requiring a covered stent may be potentially due to the combination of the low-positioned access, calcium, and/or a dissection present proximal to the access, and the patient moving during the procedure causing further bleeding.Low-positioned access may impede the collagen plug capability due to the possibility of not achieving an optimal seal and causing more difficulty to control bleeding.Additionally, dissections are a common large-bore procedural complication.Therefore, it cannot be determined if a dissection occurred prior to or during the manta deployment.Risk documentation was reviewed, and failure to close a puncture hole was identified as a known risk.The ifu lists the following potential adverse events related to the deployment of vascular closure devices including ischemia of the leg or stenosis of the femoral artery, and other access site complications leading to bleeding, hematoma, pseudoaneurysm, or arterio-venous fistula, possibly requiring blood transfusion, surgical repair, and/or endovascular intervention.As a precaution, 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.Procedure preparation suggests confirming via femoral arteriogram: no evidence of significant peripheral vascular disease or calcification in the region of the arteriotomy.

• 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: 16625935
• MDR Text Key: 312103327
• Report Number: 3010252479-2023-00062
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: 2115
• Device Catalogue Number: 2115
• Device Lot Number: MN2201462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2023
• 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): Required Intervention