MAUDE Adverse Event Report: ESSENTIAL MEDICAL, INC. 14F MANTA VASCULAR CLOSURE DEVICE

Catalog Number	2156
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "bleeding from femoral access post manta closure.A balloon and covered stent was used for hemostasis"there was no other patient harm or injury.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
Qn #: (b)(4).No product evaluation could be completed as a product was not returned for investigation.A manufacturing record review could not be completed as there was no lot number provided.Case details were reviewed.Ultrasound guidance and micropuncture were utilized to gain lower-positioned access.Following bav procedure manta was deployed.Bleeding from femoral access post manta closure was treated with a covered stent.Angios received were reviewed by and complete pull-out of manta was confirmed.The root cause for the pull-out is related to user error.The ifu posts a warning not to use manta if there is marked tortuosity of the femoral or iliac artery.The ifu precautions 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.The following potential adverse events related to the deployment of vascular closure devices include local trauma to the femoral or iliac artery wall, such as dissection and other access site complications leading to bleeding, hematoma, pseudoaneurysm, or arterio-venous fistula, possibly requiring blood transfusion, surgical repair, and/or endovascular intervention.Potential adverse events associated with any large bore intervention, including the use of the manta vascular closure device, include but are not limited to vessel laceration or trauma and late arterial bleeding.The ifu procedure preparation instructs to confirm via femoral arteriogram: no evidence of significant peripheral vascular disease or calcification in the region of the arteriotomy.The der process will continue to monitor for similar events.
Event or Problem Description
It was reported "bleeding from femoral access post manta closure.A balloon and covered stent was used for hemostasis." there was no other patient harm or injury.The patient's current condition is reported as "unknown".

• Brand Name: 14F MANTA VASCULAR CLOSURE DEVICE
• 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 27560
• MDR Report Key: 19214974
• Report Number: 3010252479-2024-00057
• Device Sequence Number: 8241459
• Product Code: MGB
• UDI-Device Identifier: 00856279007079
• UDI-Public: 00856279007079
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2156
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 72 KG