MAUDE Adverse Event Report: INTERVASCULAR SAS HEMASHIELD PLATINUM WOVEN STRAIGHT; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Model Number	M00202175210P0
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(4117) the device is not accessible for testing as it remained implanted in the patient.(4109/213) the review of historical data indicated that no other complaint was reported for the same sterilization lot number 22j07.(3331/213) the device history records review concluded that no deviation was identified in relation with the reported event.(11/213) one retention sample from the same sterilization lot number with the same fabric type (knitted) and the same coating parameters as the involved product.A visual inspection of the retention sample was performed by two qualified quality control technicians.It was concluded that the product is in compliance with the specifications.The retention sample subsequently underwent a water permeability testing and the test result is within specification (<5ml/min/cm²).(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
It was reported to intervascular that when a patient was having an impella 5.5 put in and was being cannulated with an axillary graft, the graft was leaking throughout the whole graft surface and also at the anastomosis site.The patient lost 6 liters of blood during the event.The blood was gathered with a cell saver and given back to the patient.The surgeon had to use 20ml of floseal (10ml x 2).Preveleak was also used to help with the bleeding.The patient went to the intensive care unit (icu); however, the patient had to come back to the operating room (or) for bleeding on (b)(6) 2024.
Additional Manufacturer Narrative
(4112/4248) the case and its investigation have been reviewed by the medical affairs department who concluded that: "this complaint refers to the use of a 10mm x 30cm hemashield platinum woven double velour straight graft as an access conduit to the axillary artery for the purpose of inserting an impella 5.5 support system (abiomed) on (b)(6) 2024.The graft was reported to have bled throughout its entire surface.A topical hemostat (floseal) and a surgical sealant (preveleak) were used to reestablish hemostasis.The patient was reported to have lost approximately 6 liters of blood.Blood loss was recovered during the surgery and replaced via a cell saver device.After surgery the patient was taken to the icu but was again taken back to the or due to blood loss on (b)(6) 2024.There was no additional information provided regarding the second surgery or the current status of the patient.Multiple attempts to contact the surgeon and request more information for this investigation were unsuccessful.Use of hemashield platinum woven grafts for the percutaneous insertion of the impella 5.5 device is off label.The maker of impella, abiomed, recommends the use of the hemashield platinum woven vascular graft for this purpose.Patients requiring use of the impella 5.5 support system are in cardiogenic shock.The internal investigation of historical data as well as the analysis of the retention sample were within specifications.Due to the lack of information provided a cause of bleeding cannot be determined." (4110/213) occurrence of bleeding events are reviewed monthly during quality meeting, as per internal procedure.During last meeting (september 2024), the bleeding events rate on hemashield products was within the maximum anticipated by the product risk assessment.(19) the investigation concluded that it was not possible to identify the exact origin of the adverse event since the involved product is not available for evaluation.However, the conducted investigation suggests that the product was not defective at the time of manufacturing.As stated in the medical assessment, the use of hemashield platinum woven grafts for the percutaneous insertion of the impella 5.5 device is off-label.To be noted that as per the product instructions for use, hemashield platinum woven vascular grafts are intended for use in the replacement or repair of the thoracic aorta, abdominal aorta and peripheral arteries, when open surgical operation is required.
Event or Problem Description
Complaint # (b)(4).

• Brand Name: HEMASHIELD PLATINUM WOVEN STRAIGHT
• Common Device Name: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat 13705 ; FR 13705
• Manufacturer Contact: clemence vaneenoge ; zone industrielle athelia i; la ciotat 13705 ; FR 13705 ; 442084646
• MDR Report Key: 19728128
• Report Number: 1640201-2024-00012
• Device Sequence Number: 8130670
• Product Code: MAL
• UDI-Device Identifier: 00384401018155
• UDI-Public: (01)00384401018155
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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 Model Number: M00202175210P0
• Device Catalogue Number: M00202175210P0
• Device Lot Number: 22J07
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLOSEAL AND PREVELEAK.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 106 KG