MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN HEMABRIDGE; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number HEW3210BRIDGE

Device Problem Nonstandard Device (1420)

Patient Problem Blood Loss (2597)

Event Date 04/22/2020

Event Type  Injury  

Manufacturer Narrative

Device is not accessible for testing as it remained implanted in the patient.The device history records review concludes that there is no non-conformance / planned deviation in relation with the event reported.The review of post-marketing historical data indicates that no other similar complaint was reported for the same sterilization lot number.A retention sample from same lot and coated on the same day and under the same conditions as the involved device was identified.This retention sample underwent water permeability testing.The test result indicates a value well within product specifications (< 5 ml/cm²/min).The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.

Event Description

Isolated diffuse weeping/ bleeding from the complete small connection tube.The physician cut the connection tube as much as possible and compressed the tube some time.Then he left it in the patient and no new bleeding occurred.The patient was transfused due to massive blood loss.Status of patient is stable and very good now.

Manufacturer Narrative

(4112/4210-213) the case has been reviewed by our corporate medical officer.His assessment is as follows : "the event recorded describes the use of an intergard woven hemabridge graft.The type of intervention and the patient's condition were not collected.The surgeon complaints of a significant bleeding from what i assume is the branch graft.He describes the bleeding as diffused.Without detailed information, regarding the procedure i can only assume the branch graft was used for arterial perfusion and connected to the extracorporeal circulation.In this configuration, a significant blood flow is bypassed from the heart-lung machine to the ascending aorta as the heart is stopped.The manipulation of the vascular graft and the high shear stress due to the flow could have an effect on the collagen coating potentially allowing the kind of bleeding that has been observed.The anticoagulation regimen plays also a major role in this kind of events.The lack of detailed information does not allow to make any further comment." (4315) no further investigation can be performed since the product remained implanted and due to the lack of detailed information, no conclusion can be drawn.Therefore, the cause of the event remains unknown.However, the conducted investigation suggests that the device was not defective at the time of manufacturing.(22) please note that according to the instructions for use, "care should be taken when handling the graft to avoid damaging the collagen coating." in addition, blood leakage is mentioned as an adverse effect in the instructions for use: ¿risks associated with the implantation of all synthetic vascular grafts include thrombosis/occlusion, anastomotic intimal hyperplasia, recurrent symptoms, infection, seroma formation, blood leakage, pseudoaneurysm and dilatation of the graft.¿.

Event Description

See initial mfr report#(b)(4).Complaint #(b)(4).

• Brand Name: INTERGARD WOVEN HEMABRIDGE
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): INTERVASCULAR SAS; zone industrielle athelia i; la ciotat
• MDR Report Key: 10072904
• MDR Text Key: 193968528
• Report Number: 2242352-2020-00432
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00384401001386
• UDI-Public: 00384401001386
• Combination Product (y/n): N
• PMA/PMN Number: K013651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2023
• Device Model Number: HEW3210BRIDGE
• Device Catalogue Number: HEW3210BRIDGE
• Device Lot Number: 19A24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2020
• Distributor Facility Aware Date: 06/26/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention