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

Model Number M00202175928P0

Device Problem Product Quality Problem (1506)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

The device is not accessible for testing as it remained implanted in the patient.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 22e11.The device history records review concluded that there was no non conformance/planned deviation in relation with the event reported.One retention sample from the same sterilization lot number was selected based on the same fabric type (woven), coated on a near day and under nearly similar coating parameters as the involved product.A visual inspection and water permeability testing will be performed.The investigation is still ongoing.A follow up report will be sent upon completion of the investigation.The actual device involved in the adverse event remained implanted.

Event Description

It was reported to intervascular that : "total arch graft replacement was performed with type a dissection, and during cpb weaning, overall oozing occurred in the graft, making it difficult to differentiate the bleeding of the surgical anastomosis site.After cpb was turned off and protamine and platelet ffp were transfused, oozing stopped.The graft is currently implanted in the patient." a video file of the operation was attached.It was additionally reported that during cpb weaving, oozing occurred in the graft in general and not just one part of the branch.It took about 3-40 minutes to stop oozing after cpb off and blood transfusion such as protein and platelet ffp.Platelet transmission was performed after bleeding throughout the graft in the process of blood circulation through heart pumping after removing the cardiopulmonary system.Moreover, there was no reported consequences on the patient.

Event Description

Complaint #(b)(4).

Manufacturer Narrative

(11/213) one retention sample from the same lot with the same fabric type (woven) and the same product configuration, coated two days before and with close coating parameters as the involved device was selected.A visual inspection of retention sample was performed by a quality control technician and the quality assurance supervisor, it is concluded that the retention product is in compliance with the specifications.A water permeability testing was also performed on the retention sample.The test result is within specification.(4112/213) the case and its investigation have been reviewed by the medical affairs department whose assessment is below: "this complaint refers to a hemashield platinum woven aortic arch branch graft implanted in south korea on (b)(6) 2023.The patient underwent surgery for a type a dissection.After sewing in the graft, the prosthesis began to ooze.The bleeding was generalized throughout the graft, making it challenging to determine if the anastomosis was bleeding.After the patient came off cardiopulmonary bypass and protamine and platelets were administered, the oozing stopped after 3 to 4 minutes.The surgical team did not give the platelets in response to the bleeding.The surgeon provided a short video clip of the bleeding graft but did not add any information regarding the cause of the generalized oozing.There is no information regarding what anticoagulant therapy regimen the patient was taking.Nothing unusual was observed during the procedure.The patient did not suffer any consequences due to the oozing of the graft.The surgeon is a habitual user of hemashield grafts.While it was impossible to examine the graft in question as it was not explanted, a qc technician examined the retention sample from the same lot and product family and determined that it complied with the specifications.A water permeability test was also performed on the retention sample, which was within specifications.While it is clear that the graft did ooze in a generalized fashion, as seen on the video, due to the lack of information regarding the coagulation profile of the patient and the inability to examine the prosthesis, as it remains implanted, medical affairs cannot reach a definitive conclusion as to the cause of bleeding.It is also important to note that patients that undergo emergent aortic arch surgery spend prolonged periods of time on cardiopulmonary bypass; this is known to affect hemostasis adversely and may cause intraoperative bleeding." (4110/213) occurrence of bleeding events is calculated and reviewed monthly during quality meeting.In march 2023, the bleeding rate on hemashield grafts was below the maximum anticipated by the product risk assessment.(4315) based on the investigation findings and the medical review, no conclusion can be drawn on the exact origin of the adverse event reported due to the lack of information regarding the coagulation profile of the patient and the inability to examine the prosthesis, as it remained implanted.However, the conducted investigation and testing performed suggest that the product was not defective at the time of manufacturing.Moreover, the medical affairs department underlines that generally patients that undergo emergent aortic arch surgery spend prolonged periods of time on cardiopulmonary bypass; which is known to affect hemostasis adversely and may cause intraoperative bleeding.(22) to be noted that bleeding is an undesirable side-effect as indicated in the instructions for use.

• Brand Name: HEMASHIELD PLATINUM WOVEN
• Type of Device: 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: 16602731
• MDR Text Key: 311916775
• Report Number: 2242352-2023-00238
• Device Sequence Number: 1
• Product Code: MAL
• UDI-Device Identifier: 00384401018650
• UDI-Public: (01)00384401018650
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K021213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00202175928P0
• Device Catalogue Number: M00202175928P0
• Device Lot Number: 22E11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2023
• Distributor Facility Aware Date: 04/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROTAMINE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male