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

Catalog Number	2115
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) udi will be added with the follow up report.
Event or Problem Description
It was reported that: "subject went to the er on (b)(6)2025 for the right groin bleed after the patient woke up to the bandage soaked with blood at the manta access site.The er applied pressure to the access site and changed the bandage before she was discharged.Later that evening the subject presented at the er a second time after she noted more blood on the bandage at the access site.Bleeding resolved that evening after 2 sutures were placed at the site." "date of tavr: (b)(6) 2025 ultrasound and micro puncture was used to gain access, there was no difficulty gaining access per data entry.Only one femoral arterial puncture was used in the same vessel during initial access for the interventional procedure.Target artery for manta closure: right cfa (9.0 mm) tissue depth recorded: 3.0 cm.Deployment is at 4.0 cm.Site reports 0 sheath exchanges prior to insertion of the manta sheath.Site reported no intraprocedural complication at the femoral access site before procedure sheath removal.Heparin was administered during the procedure.Act was 141 sec and systolic bp was 129 mmhg prior to closure.30mg of protamine was given prior to manta closure.Manta exp.Date: 10-apr-2025 site confirms deployment per ifu.Manta delivery system did not become kinked at any point during the case.There was no sign of bacterial contamination or antegrade puncture during the index procedure.Time to hemostasis was approximately 29 seconds per edc.".
Event or Problem Description
It was reported that: "subject went to the emergency room on (b)(6) 2025 for the right groin bleed after the patient woke up to the bandage soaked with blood at the manta access site.The er applied pressure to the access site and changed the bandage before she was discharged.Later that evening the subject presented at the er a second time after she noted more blood on the bandage at the access site.Bleeding resolved that evening after 2 sutures were placed at the site." "date of tavr: (b)(6) 2025 ultrasound and micro puncture was used to gain access, there was no difficulty gaining access per data entry.Only one femoral arterial puncture was used in the same vessel during initial access for the interventional procedure.Target artery for manta closure: right cfa (9.0 mm).Tissue depth recorded: 3.0 cm.Deployment is at 4.0 cm.Site reports 0 sheath exchanges prior to insertion of the manta sheath.Site reported no intraprocedural complication at the femoral access site before procedure sheath removal.Heparin was administered during the procedure.Act was 141 sec and systolic bp was 129 mmhg prior to closure.30mg of protamine was given prior to manta closure.Manta exp.Date: 10-apr-2025.Site confirms deployment per ifu.Manta delivery system did not become kinked at any point during the case.There was no sign of bacterial contamination or antegrade puncture during the index procedure.Time to hemostasis was approximately 29 seconds per edc.".
Additional Manufacturer Narrative
Qn#(b)(4).No return product evaluation could be completed as the device was not returned for investigation.The device history record review for lot number mn2301557 manta 18f indicated no non-conformities related to this lot, supporting that the device met material, assembly, and performance specifications before shipment.Case details were reviewed.This event is associated with the access-manta clinical study, where the patient is included if the patient meets the criteria for on-label use of manta as specified in the country-specific manta instructions for use (ifu) and is greater than or equal to 21 years of age.The patient is excluded from the study if unable or unwilling to give informed consent or reluctant to complete follow-up assessments.A 77-year-old female patient (25.86kg/m2) with a history of hypertension, heart failure, and a 30-year smoking history, presented to the or for a tavr procedure.No complications or issues were encountered during or after the deployment of the manta device.No signs of bacterial contamination or antegrade puncture are present during the index procedure, and the manta device did not become kinked at any time during the case.No adjunctive methods were required to achieve hemostasis; time to hemostasis was approximately twenty-nine seconds.Patient outcome post-procedure was fine and was discharged the following day.The patient experienced an adverse event (ae).Following discharge the next day, the patient woke up to a blood-saturated bandage at the access site and went to the er.Manual compression was applied, a new bandage was placed, and the patient was discharged.Later that evening, the patient returned to the er after noting more blood on the bandage at the access site.To address the adverse event, two sutures were applied to the access site, resolving the bleed; no additional intervention was required.The device was not returned for investigation.Post-procedural bleeding is a common occurrence following any closure device deployment as a result of the collagen requiring time to clot to create a seal or ambulation.The manta instructions for use (ifu) precautions state that if bleeding from the femoral access site persists after the use of the manta device, a ssess the situation.Based on the amount of bleeding, use manual or mechanical compression, apply balloon pressure, place a covered stent, and/or surgical repair to obtain hemostasis.There appears to be no product quality issue concerning manufacture, documentation, or labelling.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: MANTA 18F
• Common Device Name: VASCULAR CLOSURE DEVICE
• Manufacturer (Section D): ESSENTIAL MEDICAL, INC.; exton
• Manufacturer (Section G): ESSENTIAL MEDICAL, INC.; 260 sierra drive; exton
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21751916
• Report Number: 3010252479-2025-00036
• Device Sequence Number: 18553694
• Product Code: MGB
• UDI-Device Identifier: 00856279007062
• UDI-Public: (01)00856279007062(11)231004(17)250430(10)MN2301557(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P180025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 2115
• Device Lot Number: MN2301557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 73 KG