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

Model Number 2115

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422)

Event Date 04/18/2023

Event Type  malfunction  

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: pulsatile bleeding on the surface.Had to balloon at level of manta closure x2 inflations to restore flow distal to manta.8x40x135 abbott armada pta.Additional information on 19apr2023 per phone call: it was reported that there was a partial occlusion post manta deployment upon angiogram.Patient reported as fine post procedure.

Event Description

It was reported that: pulsatile bleeding on the surface.Had to balloon at level of manta closure x2 inflations to restore flow distal to manta.8x40x135 abbott armada pta.Additional information on 19apr2023 per phone call: it was reported that there was a partial occlusion post manta deployment upon angiogram.Patient reported as fine post procedure.

Manufacturer Narrative

(b)(4).The device was not returned for investigation.No return product evaluation could be completed.Angiograms were obtained by vsi however, they were inconclusive and did not provide any information relevant to the analysis.The dhr was reviewed and 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 right femoral artery.Micro puncture and ultrasound were utilized to attain higher-positioned access.Arteriotomy was.7.6mm x 8.2mm, mild posterior calcification, posterior wall calcification, and bilateral tortuosity in the iliac, with a measured depth of 5cm + 1cm.No issues were encountered advancing or withdrawing the procedural sheaths.Activated clotting time (act) prior to closure was 319, heparin was administered.The manta device was deployed to the measured depth and protamine was administered.Following deployment, pulsatile bleeding was on the surface and light pressure was held.A post-angiogram revealed a significant amount of dye decreased past the manta access.The physician indicated there was a partial occlusion since some of the dye could still get through.Two balloon inflations were applied, successfully achieving haemostasis, and the patient outcome post-procedure was fine.It is likely the cause of the occlusion is either from collagen dispositioned in the vessel or the anchor being mispositioned due to the high access site.High-access sites are listed as contraindications to the manta device due to the possibility of not achieving an optimal seal and causing more difficulty in controlling bleeding.The ifu warns not to use manta if there is marked femoral or iliac artery tortuosity.Procedure requirements state arterial access should be gained using a micro-puncture technique using ultrasound guidance to puncture the midline of the femoral artery; do not puncture the posterior wall of the artery; and activated clotting time (act) should be below 250 seconds prior to closure.Potential adverse events related to the deployment of vascular closure devices include ischemia of the leg or stenosis of the femoral artery, accidental positioning of some or all the collagen plugs within the femoral artery, leading to stenosis and other access site complications possibly requiring endovascular intervention.Procedure preparations state to confirm via femoral arteriogram: no evidence of significant peripheral vascular disease or calcification in the region of the arteriotomy.Corrected data: review of clinical outcome of the patient, the reported event indicates a malfunction and not a serious injury; therefore, section h.Has been corrected to reflect malfunction from serious injury.

• 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: 16794482
• MDR Text Key: 313808463
• Report Number: 3010252479-2023-00087
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• 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
• Device Lot Number: MN2201490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• 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
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention